Modafinil in Multiple Sclerosis
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Modafinil for Improving New Learning and Memory in Multiple Sclerosis|
- Scores on memory tests at 3 weeks and 6 weeks
- Scores on fatigue measures at 3 weeks and 6 weeks
- Scores on emotional measures at 3 weeks and 6 weeks
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||April 2006|
|United States, New Jersey|
|West Orange, New Jersey, United States, 07052|
|Principal Investigator:||Nancy D Chiaravalloti, PhD||KMRREC|