Fatigue Treatment Using Provigil
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00220506|
Recruitment Status : Unknown
Verified February 2006 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : September 22, 2005
Last Update Posted : February 17, 2006
|Condition or disease||Intervention/treatment||Phase|
|All Multiple Sclerosis Patients||Drug: Provigil||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis|
|Study Start Date :||September 2005|
|Study Completion Date :||December 2006|
- To determine fatigue impact scale
- to determine cognition measurements
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): NCT00220506
|Contact: Mark Dolev, MD||972-3-5303899|
|Contact: Anat Achiron||973-3-5303932|
|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|