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Fatigue Treatment Using Provigil

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220506
First Posted: September 22, 2005
Last Update Posted: February 17, 2006
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.
Information provided by:
Sheba Medical Center
  Purpose
To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients

Condition Intervention
All Multiple Sclerosis Patients Drug: Provigil

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • To determine fatigue impact scale

Secondary Outcome Measures:
  • to determine cognition measurements

Estimated Enrollment: 50
Study Start Date: September 2005
Estimated Study Completion Date: December 2006
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).

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Mark Dolev, MD 972-3-5303899
Contact: Anat Achiron 973-3-5303932

Locations
Israel
Multiple Sclerosis Center Recruiting
Tel Hashomer, Israel
Contact: Mark Dolev, MD    973-3-5303899      
Principal Investigator: Mark Dolev, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Mark Dolev, MD Sheba Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00220506     History of Changes
Other Study ID Numbers: SHEBA-05-3769-MD-CTIL
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: February 17, 2006
Last Verified: February 2006

Keywords provided by Sheba Medical Center:
provigil
fatigue
Multiple Sclerosis
cognition

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Fatigue
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs