Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment

Attention Deficit Hyperactivity Disorder Clinical Trial

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 425mg/Day in Patients With Attention-Deficit/Hyperactivity Disorder Who Are Responders to Modafinil Treatment, Followed by a 12-Month Open-Label Extension Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343811
• Other study ID #: C1538/3048/AD/US
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2006
• Last updated: May 8, 2014
• Start date: June 2006
• Est. completion date: September 2006

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment.

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-deficit/hyperactivity 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patients must be currently enrolled in a Cephalon-sponsored clinical study and have completed at least 12 months of continuous modafinil treatment. Patients will be included in the study if they continue to meet all applicable criteria in their previous study and all of the following criteria are met:

• Written informed consent/assent is obtained.

• The patient is currently enrolled in study C1538d/312/AD/US or C1538/3044/AD/US and received modafinil treatment, continuously, for at least 12 months.

• The patient meets the protocol criteria for response at each of the last 2 visits of their previous study. Patients from study C1538d/312/AD/US must have at least a 25% reduction in Attention-Deficit/Hyperactivity Disorder Rating Scale - IV [ADHD-RS-IV] (Home Version) total score compared with the original baseline (this must be the baseline for a previous double-blind, placebo-controlled study of modafinil in ADHD). Patients from study C1538/3044/AD/US must have at least a 25% reduction in total score of the ADHD Index subscale of the Conners' Parent Rating Scale: Revised, Short Form (CPRS:R-S), compared with the baseline value from study C1538/3044/AD/US.

• The patient is in good health (except for diagnosis of ADHD) as determined by medical and psychiatric history, physical examination, electrocardiograms (ECGs), serum chemistry, hematology, urinalysis, and vital signs.

• Girls who are post-menarche or sexually active must have a negative urine pregnancy test at the baseline visit, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include the following: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); and abstinence.

• The patient has a parent or legal guardian who is willing to participate in the study.

Exclusion Criteria:

• Patients are excluded from participating in this study if 1 or more of the following criteria are met:

• The patient has a history or current diagnosis of pervasive developmental disorder, schizophrenia, or other psychotic disorders, or positive clinical assessment of current suicide risk or ideation.

• The patient has any current psychiatric co-morbidity that requires pharmacotherapy, including but not limited to depression or other mood disorder, anxiety disorder, or pervasive mental disorder.

• The patient currently uses any other prescription medication, other than modafinil, for ADHD (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine).

• Previous exposure to modafinil caused any clinically significant (drug-related) adverse reaction that led to withdrawal from the study, or which the investigator considers likely to put the patient at risk.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Modafinil

Locations

Country	Name	City	State
United States	Child Neurology Associates	Atlanta	Georgia
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	Alpine Clinical Research	Boulder	Colorado
United States	The Clinical Study Center	Burlington	Vermont
United States	Piedmont Neuropsychiatry	Charlotte	North Carolina
United States	CNS Research Institute	Clementon	New Jersey
United States	Triangle Neuropsychiatry	Durham	North Carolina
United States	Sarkis Family Psychiatry	Gainesville	Florida
United States	Amedica Research Institute, Inc.	Hialeah	Florida
United States	UCI Child Development Center	Irvine	California
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	Michael J. Rieser, MD, PSC	Lexington	Kentucky
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Miami Research Associates	Miami	Florida
United States	Monarch Research Associates	Norfolk	Virginia
United States	Pahl Pharmaceutical Research, Inc.	Oklahoma City	Oklahoma
United States	University of Nebraska	Omaha	Nebraska
United States	Four Rivers Clinical Research, Inc.	Paducah	Kentucky
United States	OCCI, Inc.	Salem	Oregon
United States	University of California at San Francisco	San Francisco	California
United States	Pacific Institute Mental Health	Seattle	Washington
United States	Encompass Clinical Research	Spring Valley	California
United States	Clinical Neurophysiology Services	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States,