Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment
Information source: Cephalon
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Modafinil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Cephalon
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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-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).
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Clinical Study Centers, LLC, Little Rock, Arkansas 72205, United States
Encompass Clinical Research, Spring Valley, California 91978, United States
UCI Child Development Center, Irvine, California 92612, United States
University of California at San Francisco, San Francisco, California 94143, United States
Alpine Clinical Research, Boulder, Colorado 80304, United States
Sarkis Family Psychiatry, Gainesville, Florida 32607, United States
Miami Research Associates, Miami, Florida 33173, United States
Amedica Research Institute, Inc., Hialeah, Florida 33013, United States
Child Neurology Associates, Atlanta, Georgia 30342, United States
Kentucky Pediatric/Adult Research, Bardstown, Kentucky 40004, United States
Michael J. Rieser, MD, PSC, Lexington, Kentucky 40509, United States
Four Rivers Clinical Research, Inc., Paducah, Kentucky 42001, United States
Clinical Neurophysiology Services, Troy, Michigan 48085, United States
University of Nebraska, Omaha, Nebraska 68198, United States
CNS Research Institute, Clementon, New Jersey 08021, United States
Triangle Neuropsychiatry, Durham, North Carolina 27717, United States
Piedmont Neuropsychiatry, Charlotte, North Carolina 28226, United States
Pahl Pharmaceutical Research, Inc., Oklahoma City, Oklahoma 73118, United States
OCCI, Inc., Salem, Oregon 97301, United States
The Clinical Study Center, Burlington, Vermont 05401, United States
Monarch Research Associates, Norfolk, Virginia 23510, United States
Pacific Institute Mental Health, Seattle, Washington 98133, United States
Eastside Therapeutic Resource, Kirkland, Washington 98033, United States
Additional Information
Starting date: June 2006
Ending date: September 2006
Last updated: June 18, 2008
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