Recruiting

Provigil & Avonex

Sponsor:

Institute for Clinical Research

Code:

NCT00210301

Conditions

Relapsing-Remitting Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Interventions

Provigil (modafinil)

Study Details

Brief summary:

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Study ID

NCT00210301

Start date

Jan, 2003

Status verified date

Aug, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Provigil (modafinil)

Primary outcome measure

  • Comparison of AE's and SAE's to determine safety of combination [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Jeffrey A Wilken, Ph.D.

202-745-8000jeffrey.wilken@med.va.gov

Cynthia L Sullivan, Ph.D.

202-745-8000cynthia.sullivan@med.va.gov

Locations

Veterans Affairs Medical Center

Recruiting

Washington, District of Columbia, United States, 20422

Contacts

Jeffrey A Wilken, Ph.D.

202-745-8000jeffrey.wilken@med.va.gov

Cynthia L Sullivan, Ph.D.

202-745-8000Cynthia.Sullivan@med.va.gov

Principal Investigator:

Jeffrey A Wilken, Ph.D.

More Information

Sponsor

Institute for Clinical Research

Last update posted

Sep 7, 2006

Last verified

Aug, 2005

Keywords

  • MS
  • cognition
  • attention
  • fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Institute for Clinical Research on 2006-09-07.