Phase 4
N=123
Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder
Attention-Deficit/Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00877487 ↗Enrolled (actual)
123
Serious AEs
0.9%
Results posted
Aug 2011
Primary outcome: Primary: Percent of Treatment Failures at up to 6 Weeks — 8.9; 75.0 Percent of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- SPD489 (Lisdexamfetamine dimesylate) (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Treatment Failures at up to 6 Weeks |
8.9; 75.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks |
1.6; 16.8 | <0.0001 sig |
| SECONDARY Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks |
32.1; 5.0; 35.7; 11.7; 17.9; 11.7 | <0.0001 sig |
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
- 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 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.
- Subject has glaucoma.
- 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.
- Subject is female and pregnant or lactating.
- Subjects who have previously been enrolled into this study and subsequently withdrawn.
- Subject is not well controlled on SPD489 with acceptable tolerability (Adult ADHD-RS with prompts score ≥22).
Data sourced from ClinicalTrials.gov (NCT00877487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.