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Sponsored by: |
Institute for Clinical Research |
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Information provided by: | Institute for Clinical Research |
ClinicalTrials.gov Identifier: | NCT00210301 |
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.
Condition | Intervention |
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Relapsing-Remitting Multiple Sclerosis |
Drug: Provigil (modafinil) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS |
Estimated Enrollment: | 60 |
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.
Secondary Objectives:
Ages Eligible for Study: | 20 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients entering the study will:
Be English-speaking males and females between the ages of 25 and 60, inclusive [If patient is female, she must
Exclusion Criteria:
Patients entering the study will NOT:
Contact: Jeffrey A Wilken, Ph.D. | 202-745-8000 ext 7251 | jeffrey.wilken@med.va.gov |
Contact: Cynthia L Sullivan, Ph.D. | 202-745-8000 ext 7254 | cynthia.sullivan@med.va.gov |
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 jeffrey.wilken@med.va.gov | |
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 |
Study ID Numbers: | 001 |
Study First Received: | September 13, 2005 |
Last Updated: | September 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00210301 |
Health Authority: | United States: Institutional Review Board |
MS cognition attention fatigue |
Autoimmune Diseases Fatigue Multiple Sclerosis Demyelinating Diseases Interferon beta 1a Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Modafinil Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Stimulants Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions |