Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS
NCT ID: NCT00210301
Last Updated: 2006-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2003-01-31
Brief Summary
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Detailed Description
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Study Period: 6 to 12-month competitive enrollment period, two groups (Avonex and Avonex +Provigil 200 mg QD ) undergo baseline (prior to starting Provigil), 2-month, and 4-month neuropsychological evaluations. Total length of study, once initiated, (including 2 month preparation period, 6 to 12-month competitive enrollment period through final four-month visit) is 12 to 18 months.
Primary Objective: To investigate whether Provigil in combination with Avonex is safe, and tolerable in patients with RRMS.
Secondary Objectives:
1. To determine whether Provigil (modafinil) in combination with Avonex(interferon β-1a) is useful in treating deficits in attention, as measured by objective neuropsychological tests, in patients with RR-MS
2. To determine whether combination therapy (Avonex +Provigil) favorably impacts other domains of cognition that are reliant on attention (e.g., memory, psychomotor functioning), as measured by objective neuropsychological tests, in patients with RR-MS
3. To determine whether improvement in fatigue (related to treatment) predicts improvements in attention and cognitive performance in MS patients
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Provigil (modafinil)
Eligibility Criteria
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Inclusion Criteria
* Be taking Avonex
* Have normal laboratory blood tests and EKG
* Be complaining of attention problems to treating neurologist
* Be English-speaking males and females between the ages of 25 and 60, inclusive \[If patient is female, she must
* Be surgically sterile; or
* Be 2 years postmenopausal; or
* If of child-bearing potential, must be using a medically accepted method of birth control and agree to continue to use this method for the duration of the study (i.e., barrier method with spermicide, steroidal contraceptive \[oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method\], IUD, or abstinence)\]
* Have clinically definite RR MS with disease duration of less than 10 years
* Have an EDSS score between 0 and 5.5
* Have corrected vision of no worse than 20/50
* Have between 10 and 20 years of education
* Be cerebral-stimulant free for at least one week prior to Attention Screening
* Be able to complete self-rating scales and cognitive assessment tools
* Have provided written informed consent
* To have performed at least one standard deviation below normative expectation on at least two of four measures in the attention screening evaluation
Exclusion Criteria
* A history of heart disease or liver dysfunction
* Have abnormal EKG or laboratory blood work,
* Have a history of psychosis
* Be a significant risk of suicide
* Be abusing alcohol (current and within last 2 years)
* Be abusing controlled substances (current and within last 2 years)
* Have any medical ailment which can produce fatigue, such as lupus, anemia or thyroid disease
* Have any history of clinical deviation from normal ranges in the physical examination
* Have an unstable medical disorder, or medical contraindication to the use of Provigil
* Have any history of head injury, seizures, or neurological conditions involving the central nervous system other than RR MS
* Have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion, including gastrointestinal surgery
* Be a pregnant or lactating female (any patient becoming pregnant during the study will be discontinued)
* Have received any investigational product within 30 days of Cognitive Screening
* Have upper extremity dysfunction that prohibits them from using a computer mouse writing with a pencil
* Be colorblind
20 Years
65 Years
ALL
No
Sponsors
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Institute for Clinical Research
OTHER
Principal Investigators
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Jeffrey A Wilken, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Institute for Clinical Research
Locations
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Veterans Affairs Medical Center
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Jeffrey A Wilken, Ph.D.
Role: primary
Cynthia L Sullivan, Ph.D.
Role: backup
Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id