Clinical trial NCT00877487: Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Percent of Treatment Failures at up to 6 Weeks
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks
timeFrame: Up to 6 weeks
measure: Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: El Centro
country: United States
facility: Valley Clinical Research, Inc.
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates, Inc
state: California
city: San Diego
country: United States
facility: PCSD Feighner Research
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc.
state: California
city: Highlands Ranch
country: United States
facility: Colorado Clinica Trials, Inc.
state: Colorado
city: Bradenton
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Roswell
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Joliet
country: United States
facility: Joliet Center for Clinical Research
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Newton
country: United States
facility: CIENTIFICA, Inc
state: Kansas
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Prairie Village
country: United States
facility: Clinical Trial Technology Inc.
state: Kansas
city: Owensboro
country: United States
facility: Pedia Research LLC
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: Rockville
country: United States
state: Maryland
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Traverse City
country: United States
facility: The Behavioral Medicine Clinic of NW Michigan
state: Michigan
city: Troy
country: United States
facility: Behavioral Medical Center-Troy
state: Michigan
city: Saint Charles
country: United States
facility: Midwest Research Group/ St. Charles Psychiatric Associates
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine Inc.
state: Nevada
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Princeton
country: United States
facility: Global Medical Institutes, LLC. Princeton Medical Institute
state: New Jersey
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Raleigh
country: United States
facility: Richard H. Weisler, MD, PA & Associates
state: North Carolina
city: Fargo
country: United States
facility: Prarie St. Johns/ Odyssey Research
state: North Dakota
city: Cleveland
country: United States
facility: UHCMC/ Discovery and Wellness Center for Children
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Gresham
country: United States
facility: Calcagno Pediatrics
state: Oregon
city: Colmar
country: United States
facility: Introspect of Buxmont, Ltd.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Youth and Family Research Program
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Houston
country: United States
facility: Bayou City Reserch, Ltd.
state: Texas
city: Lubbock
country: United States
facility: Westex Clinical Investigators
state: Texas
city: San Antonio
country: United States
facility: Cerebral Research, LLC
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
city: Burlington
country: United States
facility: Vermont Clinical Study Center
state: Vermont
city: Woodstock
country: United States
facility: Neuropsychiatric Associates
state: Vermont
city: Charlottesville
country: United States
facility: Psychiatric Alliance of the Blue Ridge
state: Virginia
city: Midlothian
country: United States
facility: Dominion Clinical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Middleton
country: United States
facility: Dean Foundation
state: Wisconsin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.