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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00877487
Other study ID # SPD489-401
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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).

Study Design


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
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