Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder

June 9, 2021 updated by: Shire

A Phase 4, Double-Blind, Multi-Center, Placebo-Controlled, Randomized Withdrawal, Safety and Efficacy Study of SPD489 in Adults Aged 18-55 With Attention-Deficit/Hyperactivity Disorder (ADHD)

The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and are maintained on their screening dose of commercial SPD489.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Study Centers, LLC
    • California
      • El Centro, California, United States, 92243
        • Valley Clinical Research, Inc.
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates, Inc
      • San Diego, California, United States, 92108
        • PCSD Feighner Research
      • Wildomar, California, United States, 92595
        • Elite Clinical Trials, Inc.
    • Colorado
      • Highlands Ranch, Colorado, United States, 80130
        • Colorado Clinica Trials, Inc.
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center
      • Fort Myers, Florida, United States, 33912
        • Gulfcoast Clinical Research Center
      • Jacksonville, Florida, United States, 32216
        • Clinical NeuroScience Solutions Inc
      • Lauderhill, Florida, United States, 33319
        • Fidelity Clinical Research, Inc.
      • Orlando, Florida, United States, 32806
        • CNS Healthcare
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
      • West Palm Beach, Florida, United States, 33407
        • Janus Center For Psychiatric Research
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
      • Roswell, Georgia, United States, 30076
        • Northwest Behavioral Research Center
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Joliet Center for Clinical Research
      • Libertyville, Illinois, United States, 60048
        • Capstone Clinical Research
    • Kansas
      • Newton, Kansas, United States, 67114
        • CIENTIFICA, Inc
      • Overland Park, Kansas, United States, 66211
        • Psychiatric Associates
      • Overland Park, Kansas, United States, 66212
        • Vince and Associates Clinical Research
      • Prairie Village, Kansas, United States, 66206
        • Clinical Trial Technology Inc.
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Pedia Research LLC
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clinical Research
    • Maryland
      • Rockville, Maryland, United States, 20852
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Rochester Center for Behavioral Medicine
      • Traverse City, Michigan, United States, 49686
        • The Behavioral Medicine Clinic of NW Michigan
      • Troy, Michigan, United States, 48083
        • Behavioral Medical Center-Troy
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Midwest Research Group/ St. Charles Psychiatric Associates
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Premier Psychiatric Research Institute, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Center for Psychiatry And Behavioral Medicine Inc.
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Center For Emotional Fitness
      • Princeton, New Jersey, United States, 08540
        • Global Medical Institutes, LLC. Princeton Medical Institute
    • New York
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Richard H. Weisler, MD, PA & Associates
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Prarie St. Johns/ Odyssey Research
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • UHCMC/ Discovery and Wellness Center for Children
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73703
        • IPS Research Company
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Calcagno Pediatrics
    • Pennsylvania
      • Colmar, Pennsylvania, United States, 18915
        • Introspect of Buxmont, Ltd.
      • Pittsburgh, Pennsylvania, United States, 15213
        • Youth and Family Research Program
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Carolina Clinical Trials, Inc.
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • CNS Healthcare
    • Texas
      • Austin, Texas, United States, 78756
        • FutureSearch Trials
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP
      • Houston, Texas, United States, 77007
        • Bayou City Reserch, Ltd.
      • Lubbock, Texas, United States, 79423
        • Westex Clinical Investigators
      • San Antonio, Texas, United States, 78247
        • Cerebral Research, LLC
    • Utah
      • Orem, Utah, United States, 84058
        • Aspen Clinical Research
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Vermont Clinical Study Center
      • Woodstock, Vermont, United States, 05091
        • Neuropsychiatric Associates
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Psychiatric Alliance Of The Blue Ridge
      • Midlothian, Virginia, United States, 23112
        • Dominion Clinical Research
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research Center
      • Kirkland, Washington, United States, 98033
        • Eastside Therapeutic Resource
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Dean Foundation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject must be 18-55 years of age, inclusive at the time of consent.
  2. Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at baseline and agree to comply with any applicable contraceptive requirements of the protocol.
  3. Subject has a documented diagnosis of ADHD or meets DSM-IV-TR™ with adult prompts criteria by history for a primary diagnosis of ADHD prior to treatment.
  4. Subject has a Baseline score of <22 using the Adult ADHD-RS with prompts and CGI-S score ≤3.
  5. Subject has been on stable treatment with commercial SPD489 (30, 50, or 70mg) for a minimum of at least 6 months preceding the Screening Visit with acceptable tolerability.Prior treatment with commercial SPD489 in the 6 months preceding the Screening Visit must be documented by prescription records, prescribing physician notes, or pharmacy records. Those subjects whose primary care physician (PCP) is someone other than the Principal Investigator (PI) will be required to provide the above documentation to the site.
  6. Subject must have a minimum level of intellectual functioning, as determined by the Investigator.
  7. Subject is willing and able to comply with all the testing and requirements defined in this protocol.
  8. Subject is able to swallow a capsule.
  9. Subject must be able to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E627 and applicable regulations, before completing any study-related procedures.

Exclusion Criteria:

  1. Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Prohibited disorders include those associated with diagnoses including but not limited to any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder [PTSD], psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder). Other symptomatic manifestations (such as agitated states)that contraindicate treatment with SPD489 or confound efficacy or safety assessments in the opinion of the examining physician are also prohibited. Comorbid psychiatric diagnoses will be established by the psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR™ disorders (SCID-I).
  2. Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation.
  3. The subject has a body mass index (BMI) of <18.5 or ≥40.
  4. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
  5. Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
  6. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
  7. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
  8. Subject has any clinically significant ECG or clinically significant laboratory abnormality at Screening.
  9. Subject has current abnormal thyroid function, as defined as abnormal Screening thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
  10. Subject has a history of moderate to severe hypertension or has a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg. Subjects with well-controlled mild or moderate hypertension on a single antihypertensive agent are allowed.
  11. Subject is taking any medication that is excluded (Please refer to Table 2).
  12. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
  13. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR™ criteria.
  14. Subject has a positive urine drug result at Screening (with the exception of subject's current stimulant therapy).
  15. Subject has taken an investigational compound that has a central nervous system(CNS) effect or taken part in a clinical trial for ADHD 6 months prior to the Screening Visit.
  16. Subject has taken part in an investigational trial within the 30 days prior to the Screening Visit.
  17. Subject has glaucoma.
  18. Subject is taking other medications that have CNS effects or affect performance, such as chronic use of sedating antihistamines and decongestant sympathomimetics (7 days prior to Screening). Stable use of bronchodilator inhalers is not exclusionary.
  19. Subject is female and pregnant or lactating.
  20. Subjects who have previously been enrolled into this study and subsequently withdrawn.
  21. Subject is not well controlled on SPD489 with acceptable tolerability (Adult ADHD-RS with prompts score ≥22).

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.
Experimental: SPD489
Drug: SPD489 (Lisdexamfetamine dimesylate)
1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.
Other Names:
  • Vyvanse

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of Treatment Failures at up to 6 Weeks
Time Frame: Up to 6 weeks
Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score.
Up to 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks
Time Frame: Up to 6 weeks
The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Up to 6 weeks
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks
Time Frame: Up to 6 weeks
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Up to 6 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPD489-401

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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