Fatigue Treatment Using Provigil
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Modafinil
Dopamine transporter inhibitor
What it measured
Main measures
To determine fatigue impact scale
Fatigue
Other measures (1)
to determine cognition measurements
Thinking and memory
Who could take part
Relapsing MS · 18 to 55
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients
Loading reviews and guidelines…
Related trials
- MODAFIMS
Phase 2 · Recruiting
Still running
- Methylphenidate modified release as treatment of MS-assoc…
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Stopped early
- Combination Therapy (Provigil + Avonex) to Treat Cognitiv…
Not a drug-phase study · Status unknown
No result found
History
Started
Sept 2005
Finished
Dec 2006
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