Safety of SPD465 in Treating Adults With ADHD.

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00152035
• Collaborator: (none)
• Enrollment: 505
• Actual Duration (Months): 19.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 505 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
• Actual Study Start Date: Mar 10, 2005
• Actual Primary Completion Date: Nov 7, 2006
• Actual Study Completion Date: Nov 7, 2006

Outcome Measures

Primary Outcome Measures

1. 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. [Throughout the study period of approximately 20 months]

Secondary Outcome Measures

1. ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter. [Baseline, Weekly for 4 weeks, and then Monthly for 5 months.]

2. Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET). [Baseline, Weekly for 4 weeks, and then Monthly for 5 months.]

3. Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET. [Baseline, Weekly for 4 weeks, and then Monthly for 5 months.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT00152035
• Other Study ID Numbers: SPD465-304
• First Posted: Sep 9, 2005
• Last Update Posted: Aug 23, 2021
• Last Verified: Aug 1, 2021

• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Amphetamine; Dextroamphetamine; Adderall

Study Results

No Results Posted as of Aug 23, 2021