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

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877487
• Other study ID #: SPD489-401
• Status: Completed
• Phase: Phase 4
• Start date: April 30, 2009
• Est. completion date: July 8, 2010

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: July 8, 2010
• Est. primary completion date: July 8, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• SPD489 (Lisdexamfetamine dimesylate)
1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.
• Placebo
1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	FutureSearch Trials	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Florida Clinical Research Center	Bradenton	Florida
United States	Vermont Clinical Study Center	Burlington	Vermont
United States	Carolina Clinical Trials, Inc.	Charleston	South Carolina
United States	Psychiatric Alliance of the Blue Ridge	Charlottesville	Virginia
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	UHCMC/ Discovery and Wellness Center for Children	Cleveland	Ohio
United States	Introspect of Buxmont, Ltd.	Colmar	Pennsylvania
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Valley Clinical Research, Inc.	El Centro	California
United States	Prarie St. Johns/ Odyssey Research	Fargo	North Dakota
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Calcagno Pediatrics	Gresham	Oregon
United States	Colorado Clinica Trials, Inc.	Highlands Ranch	Colorado
United States	Bayou City Reserch, Ltd.	Houston	Texas
United States	Clinical Neuroscience Solutions Inc	Jacksonville	Florida
United States	Joliet Center for Clinical Research	Joliet	Illinois
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	Center for Psychiatry and Behavioral Medicine Inc.	Las Vegas	Nevada
United States	Fidelity Clinical Research, Inc.	Lauderhill	Florida
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Premier Psychiatric Research Institute, LLC	Lincoln	Nebraska
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Westex Clinical Investigators	Lubbock	Texas
United States	CNS Healthcare	Memphis	Tennessee
United States	Dean Foundation	Middleton	Wisconsin
United States	Dominion Clinical Research	Midlothian	Virginia
United States	CIENTIFICA, Inc	Newton	Kansas
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Aspen Clinical Research	Orem	Utah
United States	CNS Healthcare	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	Pedia Research LLC	Owensboro	Kentucky
United States	Four Rivers Clinical Research	Paducah	Kentucky
United States	Youth and Family Research Program	Pittsburgh	Pennsylvania
United States	Clinical Trial Technology Inc.	Prairie Village	Kansas
United States	Global Medical Institutes, LLC. Princeton Medical Institute	Princeton	New Jersey
United States	Richard H. Weisler, MD, PA & Associates	Raleigh	North Carolina
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Peninsula Research Associates, Inc	Rolling Hills Estates	California
United States	Northwest Behavioral Research Center	Roswell	Georgia
United States	Midwest Research Group/ St. Charles Psychiatric Associates	Saint Charles	Missouri
United States	Cerebral Research, LLC	San Antonio	Texas
United States	PCSD Feighner Research	San Diego	California
United States	Miami Research Associates	South Miami	Florida
United States	Richmond Behavioral Associates	Staten Island	New York
United States	The Behavioral Medicine Clinic of NW Michigan	Traverse City	Michigan
United States	Behavioral Medical Center-Troy	Troy	Michigan
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Elite Clinical Trials, Inc.	Wildomar	California
United States	Neuropsychiatric Associates	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Ju — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Treatment Failures at 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	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at 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
Secondary	Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at 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

External Links

•   FDA Approved Label
•   FDA Recall Information