Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS

September 6, 2006 updated by: Institute for Clinical Research

Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS

MS has been associated with fatigue, attention problems, and a number of cognitive difficulties. There is no treatment approved yet to treat these problems. We hypothesize that the addition of Provigil to an existing immunomodulatory agent (Avonex) will lead to improved fatigue, attention, and overall cognition in MS patients with attention problems.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

MS has been associated with fatigue, attention problems, and a number of cognitive difficulties. There is no treatment approved yet to treat these problems. Although certain immunomodulatory treatments may slow the progression of cogntiive difficulties, they are not therapy for the progression of or new onset of such problems. Therefore, in order to treat such problems, it is likely that adjunctive medications focused on fatigue and cognition are needed. We hypothesize that the addition of Provigil to an existing immunomodulatory agent (Avonex) will lead to improved fatigue, attention, and overall cognition in MS patients with attention problems.

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

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Recruiting
        • Veterans Affairs Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffrey A Wilken, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients entering the study will:

    • 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:

  • Patients entering the study will NOT:

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Comparison of AE's and SAE's to determine safety of combination

Secondary Outcome Measures

Outcome Measure
Full neuropsychological test battery (including fatigue measures) to assess effect on fatigue and cognition.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical Research

Investigators

  • Principal Investigator: Jeffrey A Wilken, Ph.D., Institute for Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

September 7, 2006

Last Update Submitted That Met QC Criteria

September 6, 2006

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Other Grant/Funding Number: Marta Eliza Miller Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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