CompletedNot a drug-phase studyMS (type not specified)NCT00142402

What it found

No result found

We found no results in the registry or in papers.

This trial finished 20 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Modafinil

    Dopamine transporter inhibitor

What it measured

Main measures

  • Scores on memory tests at 3 weeks and 6 weeks

    Thinking and memory

Other measures (2)

  • Scores on fatigue measures at 3 weeks and 6 weeks

    Fatigue
  • Scores on emotional measures at 3 weeks and 6 weeks

Who could take part

MS (type not specified) · 18 to 60

Inclusion Criteria: * Must understand English, diagnosis of Multiple Sclerosis Exclusion Criteria: * Significant language comprehension deficits, age greater than 60, less than 1-month post most recent exacerbation, current treatment with corticosteroids, significant neurological history aside from MS (e.g. epilepsy, TBI), significant substance abuse history as documented by the MAST,27 significant psychiatric history (e.g. Schizophrenia, Bipolar Disorder, Major Depression), non-fluency in the English language.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Deficits in new learning and memory in MS are a major complaint of patients, and have been noted to be a significant contributor to disability by numerous researchers. Modafinil is a psychostimulant medication, FDA approved for the treatment of Narcolepsy, with potential application for the treatment of learning and memory dysfunction in MS. This randomized clinical trial tests the efficacy of Modafinil for the treatment of new learning and memory deficits in MS. Twenty subjects with clinically definite MS and objectively documented new learning impairment will be included in the study. All subjects will undergo baseline neuropsychological testing and EDSS to document current levels of functioning in new learning and memory abilities. Subjects will then be randomly assigned to either group 1 or group 2. Group 1 (n=10) will first undergo treatment with Modafinil (200 mg once per day in the morning) for 2 weeks. They will then undergo follow-up neuropsychological assessment and follow-up EDSS to evaluate any medication effects. After the follow-up evaluation, there will be a washout period of one week in which no medication will be administered. Group 1 will then receive a placebo medication for 2 weeks. A second follow-up evaluation will be conducted following this latter arm of the study. Group 2 (n=10) will follow the same pattern, but will receive the placebo medication during the first arm of the study and Modafinil during the 2nd arm of the study. The subjects and the experimenter administering the neuropsychological evaluation will be blind to group membership.

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History

    1. Started

      Jun 2003

    2. Main results due

      Sept 2006

    3. Finished

      Sept 2006

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