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

NCT ID: NCT00877487

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-07-08

Brief Summary

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.

Conditions

Attention-Deficit/Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SPD489

Group Type: EXPERIMENTAL

SPD489 (Lisdexamfetamine dimesylate)

Intervention Type: DRUG

1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.

Interventions

SPD489 (Lisdexamfetamine dimesylate)

1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.

Intervention Type: DRUG

Placebo

1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.

Intervention Type: DRUG

Other Intervention Names

Vyvanse

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Clinical Study Centers, LLC

Little Rock, Arkansas, United States

Valley Clinical Research, Inc.

El Centro, California, United States

Peninsula Research Associates, Inc

Rolling Hills Estates, California, United States

PCSD Feighner Research

San Diego, California, United States

Elite Clinical Trials, Inc.

Wildomar, California, United States

Colorado Clinica Trials, Inc.

Highlands Ranch, Colorado, United States

Florida Clinical Research Center

Bradenton, Florida, United States

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, United States

Fidelity Clinical Research, Inc.

Lauderhill, Florida, United States

CNS Healthcare

Orlando, Florida, United States

Miami Research Associates

South Miami, Florida, United States

Janus Center for Psychiatric Research

West Palm Beach, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Northwest Behavioral Research Center

Roswell, Georgia, United States

Joliet Center for Clinical Research

Joliet, Illinois, United States

Capstone Clinical Research

Libertyville, Illinois, United States

CIENTIFICA, Inc

Newton, Kansas, United States

Psychiatric Associates

Overland Park, Kansas, United States

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Clinical Trial Technology Inc.

Prairie Village, Kansas, United States

Pedia Research LLC

Owensboro, Kentucky, United States

Four Rivers Clinical Research

Paducah, Kentucky, United States

Rockville, Maryland, United States

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, United States

The Behavioral Medicine Clinic of NW Michigan

Traverse City, Michigan, United States

Behavioral Medical Center-Troy

Troy, Michigan, United States

Midwest Research Group/ St. Charles Psychiatric Associates

Saint Charles, Missouri, United States

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, United States

Center for Psychiatry and Behavioral Medicine Inc.

Las Vegas, Nevada, United States

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Global Medical Institutes, LLC. Princeton Medical Institute

Princeton, New Jersey, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Richard H. Weisler, MD, PA & Associates

Raleigh, North Carolina, United States

Prarie St. Johns/ Odyssey Research

Fargo, North Dakota, United States

UHCMC/ Discovery and Wellness Center for Children

Cleveland, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Calcagno Pediatrics

Gresham, Oregon, United States

Introspect of Buxmont, Ltd.

Colmar, Pennsylvania, United States

Youth and Family Research Program

Pittsburgh, Pennsylvania, United States

Carolina Clinical Trials, Inc.

Charleston, South Carolina, United States

CNS Healthcare

Memphis, Tennessee, United States

FutureSearch Trials

Austin, Texas, United States

FutureSearch Trials of Dallas, LP

Dallas, Texas, United States

Bayou City Reserch, Ltd.

Houston, Texas, United States

Westex Clinical Investigators

Lubbock, Texas, United States

Cerebral Research, LLC

San Antonio, Texas, United States

Aspen Clinical Research

Orem, Utah, United States

Vermont Clinical Study Center

Burlington, Vermont, United States

Neuropsychiatric Associates

Woodstock, Vermont, United States

Psychiatric Alliance of the Blue Ridge

Charlottesville, Virginia, United States

Dominion Clinical Research

Midlothian, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Eastside Therapeutic Resource

Kirkland, Washington, United States

Dean Foundation

Middleton, Wisconsin, United States

Countries

United States

References

Brams M, Weisler R, Findling RL, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Maintenance of efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: randomized withdrawal design. J Clin Psychiatry. 2012 Jul;73(7):977-83. doi: 10.4088/JCP.11m07430. Epub 2012 Jun 12.

Reference Type: RESULT

PMID: 22780921 (View on PubMed)

Weisler RH, Babcock T, Adeyi B, Brams M. Relationship of ADHD symptoms and global illness severity in adults treated with lisdexamfetamine dimesylate. Postgrad Med. 2014 Sep;126(5):31-41. doi: 10.3810/pgm.2014.09.2798.

Reference Type: DERIVED

PMID: 25295648 (View on PubMed)

Related Links

http://www.fda.gov/opacom/7alerts.html

FDA Recall Information

Other Identifiers

SPD489-401

Identifier Type: -

Identifier Source: org_study_id