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ADHDPhase 3NCT00228540

Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD

A Phase 3 study testing Modafinil in people with ADHD, run by Cephalon at 39 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

An 8-week, Open-Label Study to Characterize the Response to Modafinil (85mg Film-Coated Tablet) Treatment at Dosages up to 425mg/Day in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) (With an Open-Ended Extension Period) Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
ADHD
What is being tested?
Modafinil
How many people
Not given
Where
39 sitesUnited States
Study dates
Sep 2005to Sep 2006
Phase
Phase 3
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 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients are included in the study if all of the following criteria are met:
  • Written informed consent/assent is obtained.
  • The patient is a boy or girl 6 through 17 years of age (inclusive) at the screening visit, and both the patient and parent/legal guardian are English-speaking.
  • The patient has a previous diagnosis of ADHD and is currently receiving medication for the treatment of ADHD.
  • The patient, or the patient's parent/legal guardian, is dissatified (VAS score <50) with current ADHD medication (medication and reason for dissatisfaction documented).
  • The patient is in good health as determined by a medical or psychiatric history, screening physical examination, and clinical laboratory evaluations.
  • Girls who are postmenarche or sexually active, must have a negative urine pregnancy test prior to 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, implant, or injected) in conjunction with a barrier method; intrauterine device (IUD); and abstinence.
  • The patient's parent/legal guardian must be willing and able to comply with study procedures and restrictions.

Who cannot join

  • Patients are excluded from participating in this study if 1 or more of the following criteria are met:
  • The patient has any current psychiatric comorbidity, including but not limited to depression or other mood disorder, or pervasive mental disorder, that requires pharmacotherapy.
  • The patient is satisfied with current ADHD medication and has no side effects.
  • The patient is using other prescription medications for ADHD with psychoactive properties (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine) after the baseline visit.
  • The patient has used monoamine oxidase (MAO) inhibitors within 1 week before the baseline visit.
  • The patient has used an investigational drug within 1 month before the screening visit.
  • The patient has a known clinically significant drug sensitivity to modafinil or any of its inactive ingredients.
  • The patient is pregnant or lactating. (Any patients becoming pregnant during the study will be withdrawn from study).

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Claghorn-Lesem Research

    Bellaire, Texas, 77401

  • Odyssey Research

    Bismarck, North Dakota, 58501

  • The Clinical Study Ceneter

    Burlington, Vermont, 05401

  • Massachusetts General Hospital

    Cambridge, Massachusetts, 02138

  • Medical University of SC

    Charleston, South Carolina, 29425

  • Bancroft Clinical Research

    Cherry Hill, New Jersey, 08034

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

  • Odyssey Research

    Dearborn, Michigan, 48126

  • Prairie at Saint John's

    Fargo, North Dakota, 58104

  • Hunterdon Pediatric Associates

    Flemington, New Jersey, 08822

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • UCI Child Development Center

    Irvine, California, 92612

  • Clinical Neuroscience Solution

    Jacksonville, Florida, 32216

  • ProMed HealthCare

    Kalamazoo, Michigan, 49008

  • Eastside Therapeutic Resource

    Kirkland, Washington, 98033

  • Michael J. Rieser, MD

    Lexington, Kentucky, 40509

  • Northwest Behavioral Research

    Marietta, Georgia, 30060

  • Loyola University Medical Center Department of Psychiatry

    Maywood, Illinois, 60153

  • Odyssey Research

    McCook, Nebraska, 69001

  • UT Medical Group

    Memphis, Tennessee, 38105

  • Clinical Neuroscience Solution

    Memphis, Tennessee, 38119

  • Dominion Clinical Research

    Midlothian, Virginia, 23112

  • Odyssey Research

    Minot, North Dakota, 58701

  • Louisiana Research Associates

    New Orleans, Louisiana, 70114

  • HALP Clinic and ADHD Research

    Northbrook, Illinois, 60062

  • Pharmacology Research Institut

    Northridge, California, 91324

  • University of Nebraska

    Omaha, Nebraska, 68198-7630

  • Clinical Neurosciences

    Orlando, Florida, 32806

  • Pedia Research, LLC

    Owensboro, Kentucky, 42301

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • OCCI, Inc Salem

    Salem, Oregon, 97301

  • Pacific Sleep Medicine Service

    San Diego, California, 92121

  • Melmed Center

    Scottsdale, Arizona, 85254

  • Psycopharmacology Research - LSU Health Science Center

    Shreveport, Louisiana, 71103

  • Advanced Pediatrics

    Vienna, Virginia, 22180

  • Laszlo J. Mate, MD, PA

    West Palm Beach, Florida, 33407

  • Cientifica, Inc.

    Wichita, Kansas, 67207

  • Pediatrics and Adolescent

    Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: An 8 Week, Open-Label Study to Characterize the Response to Modafinil (85 mg Film Coated Tablet) Treatment at Dosages Up to 425 mg/Day in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD) (With an Open Ended Extension Period)

An 8-week, Open-Label Study to Characterize the Response to Modafinil (85mg Film-Coated Tablet) Treatment at Dosages up to 425mg/Day in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) (With an Open-Ended Extension Period)

Conditions
ADHD
Being tested
Modafinil
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 posted29 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Study completionSep 2006

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00228540
Sponsor's protocol ID
C1538/3044/AD/US
Status last verified
May 2014
First submitted
27 Sep 2005
Last updated
9 May 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Modafinil in people with ADHD, run by Cephalon at 39 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 8 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 NCT00228540.

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 9 May 2014.

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