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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00877487
First received: March 19, 2009
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder
Drug: SPD489 (Lisdexamfetamine dimesylate)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Percent of Treatment Failures at up to 6 Weeks [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    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)


Enrollment: 123
Study Start Date: April 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD489 Drug: SPD489 (Lisdexamfetamine dimesylate)
1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.
Other Name: Vyvanse
Placebo Comparator: Placebo Drug: Placebo
1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877487

  Show 55 Study Locations
Sponsors and Collaborators
Shire
  More Information

Additional Information:
Publications:
Brams M, Weisler R, Findling RL, et al. Maintenance of Efficacy of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder: Randomized Withdrawal Design. J Clin Psychiatry 2012; 73(7): 977-983.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00877487     History of Changes
Other Study ID Numbers: SPD489-401
Study First Received: March 19, 2009
Results First Received: July 6, 2011
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014