Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS|
- Comparison of AE's and SAE's to determine safety of combination
- Full neuropsychological test battery (including fatigue measures) to assess effect on fatigue and cognition.
|Study Start Date:||January 2003|
MS has been associated with fatigue, attention problems, and a number of cognitive difficulties. There is no treatment approved yet to treat these problems. Although certain immunomodulatory treatments may slow the progression of cogntiive difficulties, they are not therapy for the progression of or new onset of such problems. Therefore, in order to treat such problems, it is likely that adjunctive medications focused on fatigue and cognition are needed. We hypothesize that the addition of Provigil to an existing immunomodulatory agent (Avonex) will lead to improved fatigue, attention, and overall cognition in MS patients with attention problems.
Study Period: 6 to 12-month competitive enrollment period, two groups (Avonex and Avonex +Provigil 200 mg QD ) undergo baseline (prior to starting Provigil), 2-month, and 4-month neuropsychological evaluations. Total length of study, once initiated, (including 2 month preparation period, 6 to 12-month competitive enrollment period through final four-month visit) is 12 to 18 months.
Primary Objective: To investigate whether Provigil in combination with Avonex is safe, and tolerable in patients with RRMS.
- To determine whether Provigil (modafinil) in combination with Avonex(interferon β-1a) is useful in treating deficits in attention, as measured by objective neuropsychological tests, in patients with RR-MS
- To determine whether combination therapy (Avonex +Provigil) favorably impacts other domains of cognition that are reliant on attention (e.g., memory, psychomotor functioning), as measured by objective neuropsychological tests, in patients with RR-MS
- To determine whether improvement in fatigue (related to treatment) predicts improvements in attention and cognitive performance in MS patients
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210301
|United States, District of Columbia|
|Veterans Affairs Medical Center|
|Washington, District of Columbia, United States, 20422|
|Principal Investigator:||Jeffrey A Wilken, Ph.D.||Institute for Clinical Research|