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Attention Deficit Hyperactivity DisorderPhase 2NCT00315276

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

A Phase 2 study testing Modafinil in people with Attention Deficit Hyperactivity Disorder and ADHD, run by Cephalon at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Modafinil
How many people
370 participants
Where
18 sitesUnited States
Study dates
May 2006to Jan 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Massachusetts General Hospital

    Cambridge, Massachusetts, 02138

  • South East Health Consultants, LLC

    Charleston, South Carolina, 29407

  • University of Illinois

    Chicago, Illinois, 60608

  • CRI WorldWide, LLC

    Clementon, New Jersey, 08021

  • Bay Area Research Institute

    Lafayette, California, 94549

  • Michael J. Reiser, MD, LLC

    Lexington, Kentucky, 40509

  • Neurology Clinical Study Centers, LLC

    Little Rock, Arkansas, 72205

  • Adult ADD Center of Maryland

    Lutherville, Maryland, 21093

  • Clinical Neuroscience Solution

    Memphis, Tennessee, 38119

  • New York University

    New York, New York, 10010

  • Pharmacology Research Institute

    Northridge, California, 91324

  • Clinical Neuroscience Solution, Inc.

    Orlando, Florida, 32806

  • CRI WorldWide, LLC

    Philadelphia, Pennsylvania, 19149

  • Summit Research Network Inc.

    Portland, Oregon, 97210

  • Rochester Center for Behavioral Medicine

    Rochester, Michigan, 48307

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • UCSD Medical Center

    San Diego, California, 92103

  • Neuropsychiatric Associates

    Woodstock, Vermont, 05091

Other trials in United States

About this study

Official title: 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

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.

Read the 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]).

Being tested
Modafinil
Keywords
ADHD
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ModafinilDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2006 (estimated)
  2. Study startMay 2006
  3. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
370 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00315276
Sponsor's protocol ID
C1538/2027/AD/US
Status last verified
Nov 2007
First submitted
17 Apr 2006
Last updated
24 Aug 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Modafinil in people with Attention Deficit Hyperactivity Disorder and ADHD, run by Cephalon at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00315276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012.

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Clinical Trial NCT00315276 | AzTrials