Fatigue Treatment Using Provigil
|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
|First Submitted Date ICMJE||September 14, 2005|
|First Posted Date ICMJE||September 22, 2005|
|Last Update Posted Date||February 17, 2006|
|Study Start Date ICMJE||September 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To determine fatigue impact scale|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00220506 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||to determine cognition measurements|
|Original Secondary Outcome Measures ICMJE
||to detrmine cognition mesurements|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Fatigue Treatment Using Provigil|
|Official Title ICMJE||Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis|
|Brief Summary||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:
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 ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||All Multiple Sclerosis Patients|
|Intervention ICMJE||Drug: Provigil|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||December 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 55 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Israel|
|Removed Location Countries|
|NCT Number ICMJE||NCT00220506|
|Other Study ID Numbers ICMJE||SHEBA-05-3769-MD-CTIL|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Sheba Medical Center|
|Collaborators ICMJE||Not Provided|
|PRS Account||Sheba Medical Center|
|Verification Date||February 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP