Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343811
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2006-06-21
Brief Title:
Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder ADHD Who Are Responders to Modafinil Treatment
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A 6-week Double-Blind Placebo-Controlled Parallel Group Randomized Withdrawal Study to Evaluate the Continued Efficacy of Modafinil Treatment in Dosages up to 425mgDay in Patients With Attention-DeficitHyperactivity Disorder Who Are Responders to Modafinil Treatment Followed by a 12-Month Open-Label Extension Period
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the continued efficacy of modafinil treatment compared to placebo treatment in children and adolescents with attention-deficithyperactivity disorder ADHD who are responders to modafinil treatment
Detailed Description:
The primary objective of the study is to evaluate the continued efficacy of modafinil treatment compared to placebo treatment in children and adolescents with attention-deficithyperactivity disorder ADHD who are responders to modafinil treatment as assessed by the change from baseline in this current study in the total score from the ADHD Rating Scale Fourth Edition ADHD-RS-IV Home Version at endpoint week 6 or last double-blind post-baseline visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None