NCT00210301

Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS

Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Institute for Clinical Research · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

MS has been associated with fatigue, attention problems, and a number of cognitive difficulties. There is no treatment approved yet to treat these problems. 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.

Detailed description

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. Secondary Objectives: 1. 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 2. 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 3. To determine whether improvement in fatigue (related to treatment) predicts improvements in attention and cognitive performance in MS patients

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Provigil (modafinil)

Timeline

• Start date: 2003-01-01
• First posted: 2005-09-21
• Last updated: 2006-09-07

Locations

1 site across 1 country: United States