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Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD

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ClinicalTrials.gov Identifier: NCT00315276
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : August 24, 2012
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE April 17, 2006
First Posted Date  ICMJE April 18, 2006
Last Update Posted Date August 24, 2012
Study Start Date  ICMJE May 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00315276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD
Official Title  ICMJE A 9-week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With Attention Deficit/Hyperactivity Disorder
Brief Summary The purpose of the study is to evaluate the efficacy and safety of modafinil administered once daily for 9 weeks at doses of 255, 340, 425, and 510 mg as treatment for adults with ADHD.
Detailed Description The primary objective of the study is to determine whether modafinil at 255, 340, 425, or 510 mg'day is more effective than a placebo in alleviating the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults as determined by the change from baseline in the total score from the investigator-completed Adult ADHD Investigator Symptoms Rating Scale (AISRS) the at endpoint (last post-baseline observation [week 9 or early termination]).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Attention Deficit Hyperactivity Disorder
  • ADHD
Intervention  ICMJE Drug: Modafinil
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: April¬†17,¬†2006)
370
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent is obtained.
  • The patient is 18 to 65 years of age (inclusive) at the screening visit and is English speaking.
  • At screening (after washout, if required) the patient meets the full Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for ADHD (combined type, predominantly inattentive subtype, or predominantly hyperactivity-impulsive subtype), for which symptoms were present for the age of 7 and symptoms have been persistent for at least the last 6 months, according to a psychiatric/clinical evaluation using the adult ADHD Clinical Diagnosis Scale, Version 1.2 (ACDS).
  • The patient has a Hamilton Anxiety Scale (HAM-A) and a Hamilton Depression Scale (HAM-D) score less than 15.
  • The patient has an AISRS total score of greater than 24 at the screening and baseline visits, and the difference in the total score from the screening visit to the baseline visit is less than 25%.
  • The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating for ADHD of at least 4 at the baseline visit.
  • Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception 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 contraception include barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or intrauterine device [IUD].
  • The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.

Exclusion Criteria:

  • The patient has a history or current diagnosis of schizophrenia, bipolar or other psychotic disorders, or clinical assessment of suicide risk.
  • The patient has any current psychiatric comorbidity, including but not limited to depression or other mood disorder or anxiety disorder, that requires pharmacotherapy. Comorbidities will be assessed using selected modules (ie, psychosis, substance abuse, mood disorder, anxiety disorders) of the Structured Clinical Interview for DSM-IV-TR (SCID).
  • The patient has a current diagnosis of a clinically significant sleep disorder.
  • The patient is intellectually challenged, as determined by the investigator.
  • The patient is satisfied with current ADHD medication and has no unacceptable medication side effects.
  • The patient has previously used modafinil.
  • The patient is using other prescription medications for ADHD with psychoactive properties (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine) at the baseline visit.
  • The patient has had drug or alcohol abuse or dependence within the last 6 months.
  • The patient has used monoamine oxidase (MAO) inhibitors or selective serotonin reuptake inhibitors (SSRIs) within 2 weeks before the baseline visit.
  • The patient has used an investigational drug within 1 month before the baseline visit.
  • The patient is pregnant or lactating. (Any patients becoming pregnant during the study will be withdrawn from the study).
  • The patient has any clinically significant uncontrolled medical conditions (treated or untreated).
  • The patient has a clinically significant deviation from normal in the physical examination.
  • The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00315276
Other Study ID Numbers  ICMJE C1538/2027/AD/US
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Cephalon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Teva Pharmaceutical Industries
Verification Date November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP