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Sponsored by: |
Sheba Medical Center |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00220506 |
To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients
Condition | Intervention |
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All Multiple Sclerosis Patients |
Drug: Provigil |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study |
Official Title: | Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis |
Estimated Enrollment: | 50 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2006 |
Multiple sclerosis and fatigue Fatigue is one of the most common symptoms of multiple sclerosis (MS), occurring in 30%-80% of patients and for many of them fatigue is the most disabling symptom (1). Definition of fatigue according to the MS Council for Clinical Practice Guidelines is as follows: “A subjective lack of physical and/or mental energy that is perceived by the individual or caregiver to interfere with usual and desired activities”. As fatigue is a subjective and non-specific symptom, and can easily be confused with either weakness or depressed mood, both common in MS, the following characteristics have been defined to better diagnose MS-associated fatigue:
The current medications used for the treatment of MS-associated fatigue such as amantadine hydrochloride and pemoline are useful to some, but not all patients. In a multicenter trial (2) it was found that 100 mg amantadine twice daily significantly improves fatigue. Pemoline in a placebo-controlled trial (3) failed to show significant effect on fatigue in MS patients and was poorly tolerated as side effects occurred in 25% of patients. A third trial (4) compared pemoline to amantadine and placebo, and showed only a positive trend for pemoline, while amantadine had a benefit over placebo in some fatigue measures. There was also a marked placebo effect in this trial, with approximately half of patients reporting improvement in fatigue no matter what treatment (pemoline, amantadine or placebo) they were taking. In the current study proposal we intend to evaluate the effect of Provigil on MS-associated fatigue.
The possibility for add-on drug that will affect fatigue in MS is of importance, as fatigue has a significant impact on activities of daily living, interfering with work, family life and social activities.
1.2. The fatigue scale named “Fatigue Impact Scale” The awareness of the impact of fatigue on patient’s quality of life (QOL) and the need to evaluate the effect of the different therapies on this parameter resulted in the development and validation of different questionnaires for the measurement of fatigue, i.e., the Fatigue Impact Scale (FIS), which has been shown to measure both, fatigue and treatment effect on fatigue (6-9). The FIS is a reliable and validated 40-items questionnaire that is capable of selecting a treatment effect. It is a made up of 3 sub-scales: physical, cognitive and social. Each question is scored from 0-4, allowing a total score of 160. High scores indicate high impairment.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark Dolev, MD | 972-3-5303899 | |
Contact: Anat Achiron | 973-3-5303932 |
Israel | |
Multiple Sclerosis Center | Recruiting |
Tel Hashomer, Israel | |
Contact: Mark Dolev, MD 973-3-5303899 | |
Principal Investigator: Mark Dolev, MD |
Principal Investigator: | Mark Dolev, MD | Sheba Medical Center |
Study ID Numbers: | SHEBA-05-3769-MD-CTIL |
Study First Received: | September 14, 2005 |
Last Updated: | February 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00220506 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
provigil fatigue Multiple Sclerosis cognition |
Autoimmune Diseases Fatigue Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS Central Nervous System Stimulants |
Sclerosis Neuroprotective Agents Multiple Sclerosis, Relapsing-Remitting Modafinil Autoimmune Diseases of the Nervous System |
Autoimmune Diseases Demyelinating Diseases Immune System Diseases Nervous System Diseases Physiological Effects of Drugs Sclerosis Central Nervous System Stimulants Protective Agents Neuroprotective Agents |
Multiple Sclerosis, Relapsing-Remitting Pharmacologic Actions Modafinil Multiple Sclerosis Pathologic Processes Therapeutic Uses Demyelinating Autoimmune Diseases, CNS Central Nervous System Agents Autoimmune Diseases of the Nervous System |