Modafinil in Multiple Sclerosis

NCT00142402 | Completed

• 2 other identifiers: ndcnmss2004PP0911
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Memory; New Learning; Fatigue

Outcome Measures

Primary Outcomes (1)

• Scores on memory tests at 3 weeks and 6 weeks

Secondary Outcomes (2)

• Scores on fatigue measures at 3 weeks and 6 weeks

• Scores on emotional measures at 3 weeks and 6 weeks

Interventions

Modafinil DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must understand English, diagnosis of Multiple Sclerosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nancy D Chiaravalloti, PhD

  KMRREC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: June 1, 2003
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: September 26, 2013

Record last verified: 2013-09

Locations

US (1)