All Multiple Sclerosis Patients Clinical Trial
Official title:
Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis
To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients
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:
- MS-related fatigue generally occurs on a daily basis.
- It tends to worsen as the day progresses.
- It tends to be aggravated by heat and humidity.
- It is not directly correlated with either depression or the degree of physical
impairment.
- It may occur first thing in the morning even if the patient has had a restful full
night's sleep.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment