Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS
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|ClinicalTrials.gov Identifier: NCT00210301|
Recruitment Status : Unknown
Verified August 2005 by Institute for Clinical Research.
Recruitment status was: Recruiting
First Posted : September 21, 2005
Last Update Posted : September 7, 2006
|Condition or disease||Intervention/treatment||Phase|
|Relapsing-Remitting Multiple Sclerosis||Drug: Provigil (modafinil)||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS|
|Study Start Date :||January 2003|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210301
|Contact: Jeffrey A Wilken, Ph.D.||202-745-8000 ext firstname.lastname@example.org|
|Contact: Cynthia L Sullivan, Ph.D.||202-745-8000 ext email@example.com|
|United States, District of Columbia|
|Veterans Affairs Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20422|
|Contact: Jeffrey A Wilken, Ph.D. 202-745-8000 ext 7251 firstname.lastname@example.org|
|Contact: Cynthia L Sullivan, Ph.D. 202-745-8000 ext 7254 Cynthia.Sullivan@med.va.gov|
|Principal Investigator: Jeffrey A Wilken, Ph.D.|
|Principal Investigator:||Jeffrey A Wilken, Ph.D.||Institute for Clinical Research|