A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB) (PRESENCE)

July 2, 2021 updated by: Eli Lilly and Company

Effect of LY3154207 on Cognition in Mild-to-Moderate Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)

A randomized placebo-controlled trial to evaluate the safety and efficacy of three doses of study drug LY3154207 treated for 12 weeks in participants with mild-to-moderate dementia associated with LBD (PDD or DLB).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

344

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Ottawa, Canada, K1Y 4E9
        • Ottawa Hospital Research Institute
    • Ontario
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program
  • Puerto Rico
      • Bayamón, Puerto Rico, 00961-6911
        • Santa Cruz Behavioral PSC
      • Las Piedras, Puerto Rico, 00771
        • Cortex, PSC
      • San Juan, Puerto Rico, 00918
        • Instituto De Neurologia Dra. Ivonne Fraga
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic of Scottsdale
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
      • Tucson, Arizona, United States, 85724
        • University of Arizona Health Sciences
    • California
      • Fountain Valley, California, United States, 92708
        • Parkinson's & Movement Disorder Institute
      • Irvine, California, United States, 92697
        • University of CA, Irvine
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience Network - CNS
      • Los Angeles, California, United States, 90033
        • University of Southern California School of Medicine
      • Oxnard, California, United States, 93030
        • Pacific Neuroscience Medical Group
      • Palo Alto, California, United States, 94304
        • Stanford Neuroscience Health Center
      • Pasadena, California, United States, 91105
        • SC3 Research Group Inc Pasadena
      • Reseda, California, United States, 91335
        • SC3 Research Group Inc Reseda
      • Sacramento, California, United States, 95817
        • University of California, Davis - Health Systems
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Denver, Colorado, United States, 80210
        • Denver Neurological Research
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Movement Disorders Center
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • New England Institute for Clinical Research
      • Vernon, Connecticut, United States, 06066
        • Hartford Healthcare Chase Movement Disorders Center
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health Service
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
      • Aventura, Florida, United States, 33180
        • Visionary Investigators Network
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders
      • Gainesville, Florida, United States, 32608
        • Norman Fixel Institute for Neurological Diseases (FIND)
      • Maitland, Florida, United States, 32751
        • ClinCloud, LLC
      • Miami, Florida, United States, 33133
        • Visionary Investigators Network
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
      • Miami, Florida, United States, 33176
        • VIN - Victor Faradji
      • Naples, Florida, United States, 34105
        • Collier Neurologic Specialists
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Ormond Beach, Florida, United States, 32174
        • Neurology Associates of Ormond Beach
      • Pembroke Pines, Florida, United States, 33026
        • Visionary Investigators Network -VIN-Margarita Almeida
      • Tampa, Florida, United States, 33609
        • Axiom Research
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center of Medical Research
    • Illinois
      • Winfield, Illinois, United States, 60190
        • Central DuPage Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas School of Medicine
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Neurology
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • New England Neurological Associates, PC
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Professionals
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Cleveland Clinic of Las Vegas
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Springfield, New Jersey, United States, 07081
        • The Cognitive and Research Center of NJ
      • Toms River, New Jersey, United States, 08755
        • Bio Behavioral Health
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurological Institute
      • Buffalo, New York, United States, 14203
        • Alzheimer's Disease and Memory Disorders Center
      • Glens Falls, New York, United States, 12801
        • Adirondack Medical Research
      • New Hyde Park, New York, United States, 11040
        • Parker Jewish Insititue for Heatlh Care and Rehabilition
      • New York, New York, United States, 10016
        • NYU Langone
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Carolinas HealthCare System
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Univ. Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington Neurological Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75214
        • Texas Neurology, PA
      • Dallas, Texas, United States, 75243
        • Neurology Consultants of Dallas, PA
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Ins
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Sentara Neurology Specialists
    • Washington
      • Bellevue, Washington, United States, 98007-4209
        • Northwest Clinical Research Center
      • Kirkland, Washington, United States, 98034
        • Evergreen Professional Plaza
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin-Madison Hospital and Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment.
  • Meet diagnostic criteria for PD per MDS criteria or DLB per 4th Consensus Report of the DLB Consortium.
  • Have a score on the MoCA of 10 - 23.
  • Are Modified Hoehn and Yahr Stages 0 - 4.

  • Have a blood pressure (BP) or pulse rate at screening and randomization, as determined by three sequential BP/pulse rate measurements in a seated position:

    • Participants <60 years old:

      1. A mean systolic BP less than or equal to 140 millimeters of mercury (mmHg), a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal 90 beats/minute in a seated position.
      2. Each of the 3 systolic BP measurement must be less than 180 mmHg

    • Participants ≥60 years old:

      1. A mean systolic BP less than or equal to 150 mmHg, a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal to 90 beats/min in a seated position.
      2. Each of the 3 systolic BP measurement must be less than 180 mmHg
  • If on anti-parkinsonian agents, participants must be on stable dosage for at least 3 weeks prior to screening, and should remain on stable doses during the course of the study.
  • If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
  • If on antidepressant medications, participants must be on stable dosage for at least 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
  • If on clozapine, quetiapine, and pimavanserin to address drug induced or disease related psychosis, participants must be on stable dosage for 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
  • If on antihypertensive medications, participants must be on stable dosage for at least 3 weeks prior to screening.
  • Men should use appropriate contraception.
  • All participants must have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week) and will accompany the participant to screening, baseline, day 7, day 42, day 84 and follow-up.

Exclusion Criteria:

  • Are women of childbearing potential.
  • Have significant central nervous system or psychiatric disease, other than PD or DLB, that in the investigator's opinion may affect cognition or the ability to complete the study.
  • Have a history in the last 6 months of transient ischemic attacks or ischemic stroke.
  • Have a history of intra cerebral hemorrhage due to hypertension.
  • Have a history of hypertensive encephalopathy.
  • Have atypical or secondary parkinsonism due to drugs (e.g., antipsychotics) or disease (such as progressive supranuclear palsy, essential tremor, multiple system atrophy (e.g. striatonigral degeneration, olivopontocerebellar atrophy), or postencephalitic parkinsonism).
  • Have a current implantable intracranial stimulator or history of intracranial ablation surgery (e.g., subthalamic, globus pallidus-internal segment [GPi]).
  • Have a history of substance abuse within the past 1 year (drug categories defined by the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition [DSM-5], and/or substance dependence within the past 1 year, not including caffeine and nicotine.

  • Have a serious or unstable medical illness, other than idiopathic LBD (PDD or DLB), including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or electrocardiogram (ECG) abnormality as determined by the investigator.

    • Have a history in the last 6 months of exertional angina, unstable angina, myocardial infarction, and acute coronary syndrome.
    • Have a history of heart failure of either New York Heart Association Class III or IV.
    • A history of additional risk factors for Torsades de Pointes (TdP; [e.g., chronic hypokalemia, family history of Long QT Syndrome]).
  • Participants with acute liver disease (e.g. acute viral hepatitis, alcoholic hepatitis); participants with a known chronic liver disease (e.g. hepatitis B, C, alcoholic liver disease, cirrhosis); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or higher than 2X upper limit of normal (ULN); total bilirubin (TBL) equal to or higher than 1.5X ULN; (except for participants with Gilbert's syndrome); or alkaline phosphatase (ALP) equal to or higher than 2X ULN.
  • Participants have answered 'yes' to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the Columbia Suicide Severity Rating Scale (C-SSRS)- Children's version, or answer "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt).
  • Have used antipsychotic medications, with the exception of clozapine, quetiapine, pimavanserin in the 6 months prior to screening and at any time during the course of the study.
  • Have used anticholinergics trihexyphenidyl and benztropine in the 4 weeks prior to screening and at any time during the course of the study.
  • Have motor conditions for which the antiparkinsonian treatment is expected to change during the course of the study, as well as unpredictable motor fluctuations that in the investigator's opinion would interfere with administering assessments.
  • Are taking any medications or food, herbal or dietary supplements that are inhibitors (e.g., ketoconazole, grapefruit juice), or strong/moderate inducers of cytochrome P450 3A4 (CYP3A4) (e.g., rifampicin) or are unable or unwilling to discontinue usage of them 4 weeks prior to first dose of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received placebo administered orally once a day (QD).
Drug: Placebo
Administered orally.
Experimental: 10 milligram (mg) LY3154207
Participants received 10 mg LY3154207 administered orally QD.
Drug: LY3154207
Administered orally.
Experimental: 30 mg LY3154207
Participants received 30 mg LY3154207 administered orally QD.
Drug: LY3154207
Administered orally.
Experimental: 75 mg LY3154207
Participants received 75 mg LY3154207 administered orally QD.
Drug: LY3154207
Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)
Time Frame: Baseline, Week 12
The CDR-CCB tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition). Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerized battery tests. For continuity of attention, the score range is -999 to 35. A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. Data presented are model-based bayesian posterior mean response rates with 95% credible interval.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score
Time Frame: Baseline, Week 12
The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating. A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). 1= Very much better 2= Much better 3= A little better 4= Same 5= A little worse 6= Much worse 7= Very much worse. Least squares (LS) means were calculated using mixed model repeated measures adjusting for treatment + visit + treatment*visit + age*acheifl + age + concomitant use of acetylcholinesterase inhibitor (AChEI).
Baseline, Week 12
Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score
Time Frame: Baseline, Week 12
The PoA is a composite score derived from the CDR-CCB that measures the intensity of concentration (ability to focus attention): the faster the responses, the more processes are being brought to bear upon the task. Power of attention is calculated from the sum of three cognitive function speed tests: simple reaction time, choice reaction time and the speed of detections in digit vigilance task. Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment Values are calculated by a computer and higher scores mean better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.
Baseline, Week 12
Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Time Frame: Baseline, Week 12
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.
Baseline, Week 12
Change From Screening in the Montreal Cognitive Assessment (MoCA) Score
Time Frame: Screening (Baseline), Week 12
The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale. The MoCA is divided into 7 subscores (maximum possible subscore): visuospatial/executive (5 points), naming (3 points), memory (5 points for delayed recall), attention (6 points), language (3 points), abstraction (2 points) and orientation to time and place (6 points). A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.
Screening (Baseline), Week 12
Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score and Individual Item Scores
Time Frame: Baseline, Week 12
The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD),as well as other related dementing disorders.It assesses 12 behavioral disturbances,namely delusions,hallucinations,depression/dysphoria,anxiety,agitation/aggression,elation/euphoria,disinhibition,irritability/lability,apathy, aberrant motor activity, night-time behavior disturbances,and appetite/eating abnormalities.The frequency scored from 0 (never) to 4 (very frequently).The Severity scored from 0 (none) to 3 (marked).The domain score is obtained by multiplying frequency and severity scores.The total NPI score is sum total of all of individual domain scores (0-144).Higher score indiciates more abnormal behaviors.LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Baseline, Week 12
Change From Baseline in the Epworth Sleepiness Scale (ESS) Score
Time Frame: Baseline, Week 12
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Baseline, Week 12
Change From Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I-III)
Time Frame: Baseline, Week 12
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for MDS-UPDRS MDS-UPDRS Part I (non-motor experiences of daily living) and Part II (motor experiences of daily living) scores, total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + levodopa equivalency dose (LED).
Baseline, Week 12
Change From Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score
Time Frame: Baseline, Week 12
The PDAQ-15 is a 15-item measure of instrumental activities of daily living (IADL) that are impacted by cognitive impairment in participants with parkinson's disease dementia (PDD). The PDAQ-15 is derived from the original 50-item scale, which has demonstrated test-retest reliability, construct validity, sensitivity, and specificity to Parkinson's disease (PD) cognitive impairment and the questionnaire is completed by the caregiver. The score range is 0 to 60, with higher scores indicating better function. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Baseline, Week 12
Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score
Time Frame: Baseline, Week 12
The DKEFS verbal fluency category switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. Scales scores vary from 0 min to N/A max (no concrete maximum). Higher score = higher ability in language processing. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Baseline, Week 12
Change in MDS-UPDRS Parts II (Motor Experiences of Daily Living) and III (Motor Exam) From Baseline to Week 12
Time Frame: Baseline, Week 12
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for Part II total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + LED dose.
Baseline, Week 12
Number of Participants Who Met the Potentially Clinically Significant Vital Signs Criteria at 3 Consecutive Time Points at Visit 3
Time Frame: Visit 3 (Day 1 stopping rules)
Number of participants who met the potentially clinically significant vital signs criteria at 3 consecutive time points at visit 3 were reported. In the event of an unacceptable rate of participants meeting day 1 stopping rules at other doses, adjustments to doses may be made for subsequently randomized participants at the discretion of the internal assessment committee (IAC).
Visit 3 (Day 1 stopping rules)
Change From Baseline in Clinic Blood Pressure (BP) to 8 Hours Post Dose
Time Frame: Baseline, 8 Hours Post Dose
Systolic and diastolic blood pressure obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Baseline, 8 Hours Post Dose
Change From Baseline in Pulse Rate to 8 Hours Post Dose
Time Frame: Baseline, 8 Hours Post Dose
Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Baseline, 8 Hours Post Dose
Change From Baseline In-clinic BP to Week 12
Time Frame: Baseline, Week 12
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Baseline, Week 12
Change From Baseline in Pulse Rate to Week 12
Time Frame: Baseline, Week 12
Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Baseline, Week 12
Change in Home Blood Pressure Measurement (HBPM), for SBP, DBP From Baseline to Week 12
Time Frame: Baseline, Week 12
Systolic and diastolic blood pressure obtained from ABPM was evaluated. Participants followed a standardized measurement protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Baseline, Week 12
Change in HBPM for Pulse Rate From Baseline to Week 12
Time Frame: Baseline, Week 12
Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to week 12 and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Baseline, Week 12
Change From Baseline in the Physician Withdrawal Checklist (PWC)-20 Total Score From Week 12 to In-Clinic Follow-up Visit
Time Frame: Week 12, Follow-up (2 Weeks after Week 12)

The Penn PWC-20 is a 20-item checklist originally developed to assess the severity of withdrawal symptoms in anxiolytic medication discontinuation. To determine a change in the Intensity of Discontinuation symptoms, the PWC-20 administered by a trained clinician/rater to assess the intensity of discontinuation symptoms. The assessment has 20 items evaluated to detect withdrawal symptoms. Symptoms are rated on a scale of 0-3.

0. Not present

  1. Mild
  2. Moderate
  3. Severe Total scores range from 0 to 60 with higher scores indicating more severe symptoms.Least squares (LS) means were calculated using mixed model analysis of covariance (ANCOVA) adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Week 12, Follow-up (2 Weeks after Week 12)
Pharmacokinetics (PK): Steady-State Trough Plasma Concentrations of LY3154207
Time Frame: Day 1: 1-3 hours post-dose; Day 7, Day 14 and Day 42: post-dose; Day 84: pre-dose
Trough measurements of LY3154207 concentration in plasma at Day 1, Day 7, Day 14, Day 42 and Day 84 was evaluated.
Day 1: 1-3 hours post-dose; Day 7, Day 14 and Day 42: post-dose; Day 84: pre-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2017

Primary Completion (Actual)

July 10, 2020

Study Completion (Actual)

July 10, 2020

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 5, 2017

First Posted (Actual)

October 10, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16261
  • I7S-MC-HBEH (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsor/Collaborators

Locations

3
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