Your session is about to expire
← Back to Search
Immunomodulatory Agent
Provigil + Avonex for Multiple Sclerosis
N/A
Waitlist Available
Led By Jeffrey A Wilken, Ph.D.
Research Sponsored by Institute for Clinical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients entering the study will be taking Avonex
Patients entering the study will have clinically definite RR MS with disease duration of less than 10 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing if adding Provigil to Avonex will help with fatigue, attention, and cognition problems in MS patients.
Who is the study for?
This trial is for English-speaking men and women aged 25-60 with Relapsing-Remitting Multiple Sclerosis (RR MS) of less than 10 years duration, an EDSS score of 0-5.5, and specific cognitive complaints. They must be on Avonex therapy, have normal lab tests/EKG, and use reliable birth control if applicable. Exclusions include significant medical conditions like heart disease or lupus, substance abuse history, unstable disorders affecting drug processing, or pregnancy.Check my eligibility
What is being tested?
The study is testing whether adding Provigil to Avonex treatment can improve fatigue, attention issues, and overall cognitive function in MS patients who experience attention problems. It's a combination therapy approach aiming to find an effective treatment for the cognitive difficulties associated with MS.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of Provigil may include headache, nausea, nervousness; Avonex can cause flu-like symptoms post-injection pain at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently taking Avonex.
Select...
I have relapsing-remitting MS diagnosed within the last 10 years.
Select...
My disability score is between 0 and 5.5.
Select...
I am between 25 and 60 years old and speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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.
Find a Location
Who is running the clinical trial?
Institute for Clinical ResearchLead Sponsor
3 Previous Clinical Trials
856 Total Patients Enrolled
Jeffrey A Wilken, Ph.D.Principal InvestigatorInstitute for Clinical Research
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health conditions that would make taking Provigil unsafe for me.I am not pregnant or breastfeeding.I haven't taken any brain-stimulating drugs for at least a week.I can complete self-assessment forms and cognitive tests.I do not have conditions like lupus, anemia, or thyroid disease that cause fatigue.I do not have any conditions that affect how drugs work in my body, including past stomach surgeries.I am currently taking Avonex.I have relapsing-remitting MS diagnosed within the last 10 years.My disability score is between 0 and 5.5.I am a woman who cannot become pregnant or am using birth control.I have RR MS but no history of head injuries, seizures, or other CNS conditions.I do not have a history of heart disease or liver problems.I am between 25 and 60 years old and speak English.I have completed between 10 and 20 years of schooling.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are octogenarians being considered for involvement in this research?
"This trial is available to those between the ages of 20 and 65. However, there are other trials specific for minors (26) and seniors (243)."
Answered by AI
Can I be accepted into this medical experiment?
"The requisite qualifications to partake in this study necessitate that the patient have MS and be between 20-65 years old. There is still capacity for around 60 participants."
Answered by AI
Are there still vacancies for volunteers in this clinical experiment?
"Clinicaltrials.gov states that this study is not accepting applicants at present, having been first posted on January 1st 2003 and last updated 6th September 2006. However, with 390 other medical trials currently recruiting patients there are numerous opportunities to participate in similar research."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger