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Modafinil in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00142402
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : September 26, 2013
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Nancy Chiaravalloti, Kessler Foundation

Brief Summary:

Deficits in new learning and memory in MS are a major complaint of patients, and have been noted to be a significant contributor to disability by numerous researchers. Modafinil is a psychostimulant medication, FDA approved for the treatment of Narcolepsy, with potential application for the treatment of learning and memory dysfunction in MS. This randomized clinical trial tests the efficacy of Modafinil for the treatment of new learning and memory deficits in MS.

Twenty subjects with clinically definite MS and objectively documented new learning impairment will be included in the study. All subjects will undergo baseline neuropsychological testing and EDSS to document current levels of functioning in new learning and memory abilities. Subjects will then be randomly assigned to either group 1 or group 2. Group 1 (n=10) will first undergo treatment with Modafinil (200 mg once per day in the morning) for 2 weeks. They will then undergo follow-up neuropsychological assessment and follow-up EDSS to evaluate any medication effects. After the follow-up evaluation, there will be a washout period of one week in which no medication will be administered. Group 1 will then receive a placebo medication for 2 weeks. A second follow-up evaluation will be conducted following this latter arm of the study. Group 2 (n=10) will follow the same pattern, but will receive the placebo medication during the first arm of the study and Modafinil during the 2nd arm of the study. The subjects and the experimenter administering the neuropsychological evaluation will be blind to group membership.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Modafinil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Modafinil for Improving New Learning and Memory in Multiple Sclerosis
Study Start Date : June 2003
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil

Primary Outcome Measures :
  1. Scores on memory tests at 3 weeks and 6 weeks

Secondary Outcome Measures :
  1. Scores on fatigue measures at 3 weeks and 6 weeks
  2. Scores on emotional measures at 3 weeks and 6 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must understand English, diagnosis of Multiple Sclerosis

Exclusion Criteria:

  • Significant language comprehension deficits, age greater than 60, less than 1-month post most recent exacerbation, current treatment with corticosteroids, significant neurological history aside from MS (e.g. epilepsy, TBI), significant substance abuse history as documented by the MAST,27 significant psychiatric history (e.g. Schizophrenia, Bipolar Disorder, Major Depression), non-fluency in the English language.

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): NCT00142402

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United States, New Jersey
Kessler Foundation
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
National Multiple Sclerosis Society
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Principal Investigator: Nancy D Chiaravalloti, PhD KMRREC
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Responsible Party: Nancy Chiaravalloti, Director, Kessler Foundation
ClinicalTrials.gov Identifier: NCT00142402    
Other Study ID Numbers: ndcnmss2004
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013
Keywords provided by Nancy Chiaravalloti, Kessler Foundation:
Multiple Sclerosis
New Learning
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action