- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04417907
Perampanel Titration and Cognitive Effects
February 4, 2023 updated by: Kimford Jay Meador
Effects of Titration Rate on Cognitive and Behavioral Side Effects of Perampanel
The objective of this study is to determine whether there are any differences in the cognitive abilities and/or behavioral response of normal healthy volunteers across different titration rates of perampanel.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, double-blind, parallel group design across different titration rates of perampanel in healthy volunteers.
The study consists of 8 visits, 4 of which will occur at the participant's home, over a 7-week period.
One hundred and three (103) normal healthy subjects will be treated with perampanel (PER) at one of four different titration rates: (1) 2mg/day PER for one week followed by 4mg/day PER for five weeks, (2) 2mg/day PER for two weeks followed by 4mg/day PER for four weeks, (3) 4mg/day PER for six weeks, or (4) placebo (0mg/day PER) for six weeks.
Cognitive and behavioral function testing along with safety testing will be conducted at screening, pretreatment baseline, the end of each week during the titration and maintenance period.
Study Type
Interventional
Enrollment (Anticipated)
103
Phase
- Phase 4
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
-
-
California
-
Palo Alto, California, United States, 94304
- Recruiting
- Stanford University
-
Principal Investigator:
- Kimford Meador, MD
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Not yet recruiting
- Northwestern University
-
Contact:
- Elizabeth Bachman, MPH
- Email: elizabeth.bachman@nm.org
-
Principal Investigator:
- Elizabeth Gerard, MD
-
-
New York
-
New York, New York, United States, 10016
- Not yet recruiting
- New York University
-
Contact:
- Samantha Martin, MA
- Email: samantha.martin@nyulangone.org
-
Principal Investigator:
- Beth Leeman-Markowski, MD
-
-
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
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults between the ages of 18 and 55 years
- Male or female (using approved birth control methods)
- Informed consent obtained
Exclusion Criteria:
- Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease.
- Presence or history of drug or alcohol abuse or positive urine drug test at screening.
- The use of concomitant medications, which are known to affect perampanel or the use of any concomitant medications that may alter cognitive function (see Section VIII.F for a partial list).
- Prior adverse reaction to or prior hypersensitivity to perampanel.
- Prior participation in studies involving perampanel.
- Subjects who have received any investigational drug within the previous thirty days.
- Subjects with IQ < 80 as determined by the Peabody Picture Vocabulary Test after enrollment.
- Positive pregnancy test. Women of childbearing potential will be required to use approved birth control methods during the study.
- Presence of lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the C-SSRS at Screening.
- Invalid results on computerized cognitive tests at screening as indicated by a 'No' on any of the validity indicators generated in the CNS Vital Signs report.
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Participants will take 2mg placebo PO QD for six weeks.
|
Healthy adults will take 2mg placebo PO QD for six weeks
|
EXPERIMENTAL: PER 1 Week Titration
Participants will take 2mg perampanel PO QD for one week, followed by 4mg perampanel PO QD for five weeks.
|
Healthy adults will take 2mg perampanel PO QD for one week followed 4mg perampanel PO QD for five weeks.
Other Names:
|
EXPERIMENTAL: PER 2 Week Titration
Participants will take 2mg perampanel PO QD for two weeks, followed by 4mg perampanel PO QD for four weeks.
|
Healthy adults will take 2mg perampanel PO QD for two weeks followed 4mg perampanel PO QD for four weeks.
Other Names:
|
EXPERIMENTAL: PER 4 mg
Participants will take 4mg perampanel PO QD for six weeks
|
Healthy adults will take 4mg perampanel PO QD for six weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall neuropsychological composite Z-score as a measure of direct comparison of the 4 titration conditions across 6 weeks of treatment.
Time Frame: At the end of each week of treatment for 6 weeks plus a baseline measure for control.
|
Z score of cognitive tests (selected performance measures from the computerized cognitive test battery) and questionnaires (AEP, POMS, QOLIE-cognitive questions) at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment.
The Z-score indicates the number of standard deviations away from a reference population.
A Z-score of 0 is equal to the mean.
Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean.
|
At the end of each week of treatment for 6 weeks plus a baseline measure for control.
|
Composite Z-score of objective measures as a measure of direct comparison of the 4 titration conditions across 6 weeks of treatment.
Time Frame: At the end of each week of treatment for 6 weeks plus a baseline measure for control.
|
Z score of objective cognitive tests (selected performance measures from the computerized cognitive test battery) at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment.
The Z-score indicates the number of standard deviations away from a reference population.
A Z-score of 0 is equal to the mean.
Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean.
|
At the end of each week of treatment for 6 weeks plus a baseline measure for control.
|
Composite Z-score of subjective measures as a measure of direct comparison of the 4 titration conditions across 6 weeks of treatment.
Time Frame: At the end of each week of treatment for 6 weeks plus a baseline measure for control.
|
Z score of subjective questionnaires (AEP, POMS, QOLIE-cognitive questions at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment.
The Z-score indicates the number of standard deviations away from a reference population.
A Z-score of 0 is equal to the mean.
Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean.
|
At the end of each week of treatment for 6 weeks plus a baseline measure for control.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall neuropsychological composite Z-score at the end of the maintenance period (study week 6) compared to baseline (study week 1) as a measure of direct comparison of change across the 4 titration conditions.
Time Frame: At the end of the 6 week maintenance period plus a baseline measure for comparison.
|
Z score of cognitive tests (selected performance measures from the computerized cognitive test battery), questionnaires (AEP, POMS, QOLIE-cognitive questions), and non-computerized cognitive scores (average of z-scores for MCG immediate, MCG delayed, SDMT, Stroop-average score) at the end of the maintenance period, compared to baseline measures collected prior to treatment.
The Z-score indicates the number of standard deviations away from a reference population.
A Z-score of 0 is equal to the mean.
Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean.
|
At the end of the 6 week maintenance period plus a baseline measure for comparison.
|
Overall cognitive composite Z-score at the end of the maintenance period (study week 6) compared to baseline (study week 1) as a measure of direct comparison of change across the 4 titration conditions.
Time Frame: At the end of the 6 week maintenance period plus a baseline measure for comparison.
|
Z score of cognitive tests (selected performance measures from the computerized cognitive test battery) and non-computerized cognitive scores (average of z-scores for MCG immediate, MCG delayed, SDMT, Stroop-average score) at the end of the maintenance period, compared to baseline measures collected prior to treatment.
The Z-score indicates the number of standard deviations away from a reference population.
A Z-score of 0 is equal to the mean.
Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean.
|
At the end of the 6 week maintenance period plus a baseline measure for comparison.
|
Overall behavioral composite Z-score at the end of the maintenance period (study week 6) compared to baseline (study week 1) as a measure of direct comparison of change across the 4 titration conditions.
Time Frame: At the end of the 6 week maintenance period plus a baseline measure for comparison.
|
Z score of behavioral tests and questionnaires (AEP, POMS, QOLIE-cognitive questions) at the end of the maintenance period, compared to baseline measures collected prior to treatment.
The Z-score indicates the number of standard deviations away from a reference population.
A Z-score of 0 is equal to the mean.
Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean.
|
At the end of the 6 week maintenance period plus a baseline measure for comparison.
|
Treatment Emergent Adverse Events (TEAEs) across the six-week treatment period measure of direct comparison of the 4 titration conditions across 6 weeks of treatment.
Time Frame: At the end of each week of treatment for 6 weeks.
|
Number of TEAEs across the the four titration conditions over the six-week treatment period.
A score of 0 indicates no TEAEs.
Higher numbers indicate greater TEAEs.
|
At the end of each week of treatment for 6 weeks.
|
Dropouts across the six-week treatment period measure of direct comparison of the 4 titration conditions across 6 weeks of treatment.
Time Frame: At the end of each week of treatment for 6 weeks.
|
Number dropouts across the the four titration conditions over the six-week treatment period.
A score of 0 indicates no dropouts.
Higher numbers indicate greater dropouts.
|
At the end of each week of treatment for 6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
October 20, 2021
Primary Completion (ANTICIPATED)
September 30, 2023
Study Completion (ANTICIPATED)
September 30, 2023
Study Registration Dates
First Submitted
June 2, 2020
First Submitted That Met QC Criteria
June 2, 2020
First Posted (ACTUAL)
June 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 4, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 54358
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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