NCT00210301

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

September 7, 2006

Status Verified

August 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 6, 2006

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

MScognitionattentionfatigue

Outcome Measures

Primary Outcomes (1)

  • Comparison of AE's and SAE's to determine safety of combination

Secondary Outcomes (1)

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

Interventions

Provigil (modafinil)DRUG

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Medical Center

Washington D.C., District of Columbia, 20422, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingFatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jeffrey A Wilken, Ph.D.

    Institute for Clinical Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey A Wilken, Ph.D.

CONTACT

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

Cynthia L Sullivan, Ph.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2003

Last Updated

September 7, 2006

Record last verified: 2005-08

Locations

US(1)