Fatigue Treatment Using Provigil

• Status: Unknown status
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.