Back to resultsSafety of SPD465 in Treating Adults With ADHD.
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
Eligibility Criteria
Inclusion Criteria: Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events. Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods. Exclusion Criteria: Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol. Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders. History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder. Females who are pregnant of lactating.
Sites / Locations
Outcomes
Primary Outcome Measures
The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
Secondary Outcome Measures
ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.
Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).
Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00152035
Brief Title
Safety of SPD465 in Treating Adults With ADHD.
Official Title
A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2005 (Actual)
Primary Completion Date
November 7, 2006 (Actual)
Study Completion Date
November 7, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
505 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.
Primary Outcome Measure Information:
Title
The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
Time Frame
Throughout the study period of approximately 20 months
Secondary Outcome Measure Information:
Title
ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.
Time Frame
Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Title
Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).
Time Frame
Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Title
Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.
Time Frame
Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.
Exclusion Criteria:
Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
Females who are pregnant of lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety of SPD465 in Treating Adults With ADHD.
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