Clinical trial NCT00343811: Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention-Deficit/Hyper Activity Disorder
ADHD
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-deficit/hyperactivity 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-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 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.

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