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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00202605
Other study ID # SPD465-203
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 29, 2005
Est. completion date January 6, 2006

Study information

Verified date June 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date January 6, 2006
Est. primary completion date January 6, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis

Intervention

Drug:
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate


Locations

Country Name City State
United States Bayou City Research, Ltd. Houston Texas
United States UCI Child Development Center Irvine California
United States Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada
United States Clinical Study Center Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PERMP (Permanent Product Measure of Performance) 0.5 hours pre-dosing
Primary PERMP (Permanent Product Measure of Performance) 2 hours post-dosing
Primary PERMP (Permanent Product Measure of Performance) 4 hours post-dosing
Primary PERMP (Permanent Product Measure of Performance) 8 hours post-dosing
Primary PERMP (Permanent Product Measure of Performance) 12 hours post-dosing
Primary PERMP (Permanent Product Measure of Performance) 14 hours post-dosing
Primary PERMP (Permanent Product Measure of Performance) 16 hours post-dosing
Secondary Time Segment Rating System (ADHD-RS[TSRS]) 5½, 11, and 16½ hours post-dosing
Secondary Subject self report (ADHD-SRS) of ADHD approximately 5½, 11, and 16½ hours post-dosing
Secondary Treatment emergent adverse events Throughout the study period of approximately 3.25 months.
Secondary 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
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