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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Institute for Clinical Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institute for Clinical Research
ClinicalTrials.gov Identifier:
NCT00210301
First received: September 13, 2005
Last updated: September 6, 2006
Last verified: August 2005
  Purpose

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.


Condition Intervention
Relapsing-Remitting Multiple Sclerosis
Drug: Provigil (modafinil)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS

Resource links provided by NLM:


Further study details as provided by Institute for Clinical Research:

Primary Outcome Measures:
  • Comparison of AE's and SAE's to determine safety of combination

Secondary Outcome Measures:
  • Full neuropsychological test battery (including fatigue measures) to assess effect on fatigue and cognition.

Estimated Enrollment: 60
Study Start Date: January 2003
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
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00210301

Contacts
Contact: Jeffrey A Wilken, Ph.D. 202-745-8000 ext 7251 jeffrey.wilken@med.va.gov
Contact: Cynthia L Sullivan, Ph.D. 202-745-8000 ext 7254 cynthia.sullivan@med.va.gov

Locations
United States, District of Columbia
Veterans Affairs Medical Center Recruiting
Washington, District of Columbia, United States, 20422
Contact: Jeffrey A Wilken, Ph.D.    202-745-8000 ext 7251    jeffrey.wilken@med.va.gov   
Contact: Cynthia L Sullivan, Ph.D.    202-745-8000 ext 7254    Cynthia.Sullivan@med.va.gov   
Principal Investigator: Jeffrey A Wilken, Ph.D.         
Sponsors and Collaborators
Institute for Clinical Research
Investigators
Principal Investigator: Jeffrey A Wilken, Ph.D. Institute for Clinical Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00210301     History of Changes
Other Study ID Numbers: 001
Study First Received: September 13, 2005
Last Updated: September 6, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Institute for Clinical Research:
MS
cognition
attention
fatigue

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

ClinicalTrials.gov processed this record on August 01, 2014