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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provigil (modafinil)
Sponsored by
Institute for Clinical Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring MS, cognition, attention, fatigue

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Affairs Medical CenterRecruiting

Outcomes

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.

Full Information

First Posted
September 13, 2005
Last Updated
September 6, 2006
Sponsor
Institute for Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00210301
Brief Title
Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS
Official Title
Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institute for Clinical Research

4. Oversight

5. Study Description

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.
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: 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 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 To determine whether improvement in fatigue (related to treatment) predicts improvements in attention and cognitive performance in MS patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
Keywords
MS, cognition, attention, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Provigil (modafinil)
Primary Outcome Measure Information:
Title
Comparison of AE's and SAE's to determine safety of combination
Secondary Outcome Measure Information:
Title
Full neuropsychological test battery (including fatigue measures) to assess effect on fatigue and cognition.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey A Wilken, Ph.D.
Phone
202-745-8000
Ext
7251
Email
jeffrey.wilken@med.va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia L Sullivan, Ph.D.
Phone
202-745-8000
Ext
7254
Email
cynthia.sullivan@med.va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Wilken, Ph.D.
Organizational Affiliation
Institute for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Wilken, Ph.D.
Phone
202-745-8000
Ext
7251
Email
jeffrey.wilken@med.va.gov
First Name & Middle Initial & Last Name & Degree
Cynthia L Sullivan, Ph.D.
Phone
202-745-8000
Ext
7254
Email
Cynthia.Sullivan@med.va.gov
First Name & Middle Initial & Last Name & Degree
Jeffrey A Wilken, Ph.D.

12. IPD Sharing Statement

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

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