Fatigue Treatment Using Provigil

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00220506
First received: September 14, 2005
Last updated: February 16, 2006
Last verified: February 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00220506     History of Changes
Other Study ID Numbers: SHEBA-05-3769-MD-CTIL
Study First Received: September 14, 2005
Last Updated: February 16, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Fatigue
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on October 20, 2014