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Clinical Trials/NCT00202605
NCT00202605CompletedPhase 2

A Phase II, Randomized, Double-Blind, Multi-center, Placebo-controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Shire4 sites in 1 country72 target enrollmentStarted: September 29, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Shire
Enrollment
72
Locations
4
Primary Endpoint
PERMP (Permanent Product Measure of Performance)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Primary diagnosis of ADHD using DSM-IV-TR criteria (at least 6 of the 9 subtype criteria met)
  • •Baseline ADHD-RS-IV score =>24
  • •IQ score of => 80 (using Kaufman Brief Intelligence Test)

Exclusion Criteria

  • •BMI < 18.5 or > 30 kg/m2
  • •Diagnosis of Post Traumatic Stress Disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
  • •History of seizure disorder or a lifetime history of any seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
  • •History of uncontrolled hypertension or currently hypertensive
  • •Subjects who have taken atomoxetine (STRATTERA) within 30 days prior to screening
  • •Current (or history within the last 12 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine)
  • •Female subject is pregnant or lactating, less than 3 months post partum

Outcomes

Primary Outcomes

PERMP (Permanent Product Measure of Performance)

Time Frame: 16 hours post-dosing

Secondary Outcomes

  • Subject self report (ADHD-SRS) of ADHD(approximately 5½, 11, and 16½ hours post-dosing)
  • Treatment emergent adverse events(Throughout the study period of approximately 3.25 months.)
  • Modified Pittsburgh Sleep Quality Index (PSQI)(Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit)
  • Time Segment Rating System (ADHD-RS[TSRS])(5½, 11, and 16½ hours post-dosing)

Investigators

Sponsor
Shire
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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