Status:
UNKNOWN
Fatigue Treatment Using Provigil
Lead Sponsor:
Sheba Medical Center
Conditions:
All Multiple Sclerosis Patients
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients
Detailed Description
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). ...
Eligibility Criteria
Inclusion
- The patients should be diagnosed with clinically definite MS (Posner criteria).
- EDSS at screening: 0 to 5.5, inclusive.
- Positive Fatigue impact scale 40 points or more.
- Age 18-55 years.
- Co-operating patient, capable of complying with all of trial procedures (i.e. FIS, QOL, etc…).
- Patient who signed written informed consent.
- Women of childbearing potential must use effective birth control method during study.
Exclusion
- Life threatening and/or unstable clinical condition which in the opinion of the investigator might compromise trial completion
- A relapse during the last 30 days prior to the study.
- Systemic steroid therapy within 30 days
- Known hypersensitivity or intolerance, to Provigil or related substances or to any component of the formulation.
- Sleep apnea
- Narcolepsy
- Participation in experimental drug trials during the last 30 days prior to the trial.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00220506
Start Date
September 1 2005
End Date
December 1 2006
Last Update
February 17 2006
Active Locations (1)
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1
Multiple Sclerosis Center
Tel Litwinsky, Israel