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

NCT00877487 | Completed Phase 4 Results

• 1 other identifier: SPD489-401
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 55

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

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks

  Up to 6 weeks

• Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks

  Up to 6 weeks

Study Arms (2)

SPD489

EXPERIMENTAL

Drug: SPD489 (Lisdexamfetamine dimesylate)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SPD489 (Lisdexamfetamine dimesylate) DRUG

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

Also known as: Vyvanse

SPD489

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must be 18-55 years of age, inclusive at the time of consent.
• 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.
• 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.
• Subject has a Baseline score of \<22 using the Adult ADHD-RS with prompts and CGI-S score ≤3.
• 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.
• Subject must have a minimum level of intellectual functioning, as determined by the Investigator.
• Subject is willing and able to comply with all the testing and requirements defined in this protocol.
• Subject is able to swallow a capsule.
• 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.

You may not qualify if:

• 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).
• 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.
• The subject has a body mass index (BMI) of \<18.5 or ≥40.
• 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.
• 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.
• Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
• Subject has any clinically significant ECG or clinically significant laboratory abnormality at Screening.
• 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.
• 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.
• Subject is taking any medication that is excluded (Please refer to Table 2).
• Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
• 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.
• Subject has a positive urine drug result at Screening (with the exception of subject's current stimulant therapy).
• 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.
• Subject has taken part in an investigational trial within the 30 days prior to the Screening Visit.

Sponsors & Collaborators

• Shire: lead

Study Sites (55)

Clinical Study Centers, LLC

Little Rock, Arkansas, 72205, United States

Location

Valley Clinical Research, Inc.

El Centro, California, 92243, United States

Location

Peninsula Research Associates, Inc

Rolling Hills Estates, California, 90274, United States

Location

PCSD Feighner Research

San Diego, California, 92108, United States

Location

Elite Clinical Trials, Inc.

Wildomar, California, 92595, United States

Location

Colorado Clinica Trials, Inc.

Highlands Ranch, Colorado, 80130, United States

Location

Florida Clinical Research Center

Bradenton, Florida, 34208, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, 32216, United States

Location

Fidelity Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

Location

CNS Healthcare

Orlando, Florida, 32806, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Janus Center for Psychiatric Research

West Palm Beach, Florida, 33407, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Northwest Behavioral Research Center

Roswell, Georgia, 30076, United States

Location

Joliet Center for Clinical Research

Joliet, Illinois, 60435, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

CIENTIFICA, Inc

Newton, Kansas, 67114, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Clinical Trial Technology Inc.

Prairie Village, Kansas, 66206, United States

Location

Pedia Research LLC

Owensboro, Kentucky, 42301, United States

Location

Four Rivers Clinical Research

Paducah, Kentucky, 42003, United States

Location

Unknown Facility

Rockville, Maryland, 20852, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

The Behavioral Medicine Clinic of NW Michigan

Traverse City, Michigan, 49686, United States

Location

Behavioral Medical Center-Troy

Troy, Michigan, 48083, United States

Location

Midwest Research Group/ St. Charles Psychiatric Associates

Saint Charles, Missouri, 63301, United States

Location

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68510, United States

Location

Center for Psychiatry and Behavioral Medicine Inc.

Las Vegas, Nevada, 89128, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Global Medical Institutes, LLC. Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Richard H. Weisler, MD, PA & Associates

Raleigh, North Carolina, 27609, United States

Location

Prarie St. Johns/ Odyssey Research

Fargo, North Dakota, 58104, United States

Location

UHCMC/ Discovery and Wellness Center for Children

Cleveland, Ohio, 44106, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73703, United States

Location

Calcagno Pediatrics

Gresham, Oregon, 97030, United States

Location

Introspect of Buxmont, Ltd.

Colmar, Pennsylvania, 18915, United States

Location

Youth and Family Research Program

Pittsburgh, Pennsylvania, 15213, United States

Location

Carolina Clinical Trials, Inc.

Charleston, South Carolina, 29407, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials

Austin, Texas, 78756, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Bayou City Reserch, Ltd.

Houston, Texas, 77007, United States

Location

Westex Clinical Investigators

Lubbock, Texas, 79423, United States

Location

Cerebral Research, LLC

San Antonio, Texas, 78247, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

Vermont Clinical Study Center

Burlington, Vermont, 05401, United States

Location

Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States

Location

Psychiatric Alliance of the Blue Ridge

Charlottesville, Virginia, 22903, United States

Location

Dominion Clinical Research

Midlothian, Virginia, 23112, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Dean Foundation

Middleton, Wisconsin, 53562, United States

Location

Related Publications (2)

• 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.

  PMID: 22780921 RESULT

• 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.

  PMID: 25295648 DERIVED

Related Links

• FDA Recall Information

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: April 7, 2009
• Study Start: April 30, 2009
• Primary Completion: July 8, 2010
• Study Completion: July 8, 2010
• Last Updated: June 22, 2021
• Results First Posted: August 2, 2011

Record last verified: 2021-06

Locations

US (55)