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Combination Therapies for Multiple Sclerosis
Phase 1 & 2
Recruiting
Led By Bibiana Bielekova, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented sustained clinical progression of at least 0.5 CombiWISE points/year (measured by greater than or equal to 4 time-points regression analysis of CombiWISE values spanning at least 1.5 years in total)
Expanded Disability Status Scale (EDSS) 1.0-7.5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
Study Summary
This trial is testing whether or not biomarkers in the cerebrospinal fluid can help predict a person's response to different drugs for multiple sclerosis.
Who is the study for?
Adults over 18 with progressive MS, able to walk a few steps, and currently in protocol 09-I-0032 can join. They must have shown MS progression and agree to birth control if applicable. Participants can continue their FDA-approved MS drugs but may need to stop if they change treatments.Check my eligibility
What is being tested?
The trial tests whether Dantrolene, Pirfenidone, Pioglitazone, or clemastine fumarate alone or combined affect MS biomarkers in the brain/CSF. It aims to predict drug response based on these biomarker changes during up to an 18-month treatment period.See study design
What are the potential side effects?
Potential side effects include allergic reactions to the medications; liver issues from Dantrolene or Pirfenidone; heart failure risk with Pioglitazone; and hypoglycemia when combining Pioglitazone with certain drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition has worsened by at least 0.5 points/year over 1.5 years.
Select...
My disability level is moderate to severe but I can still perform some daily activities.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
will be change in CombiWISE progression rate at the end of monotherapy plus combination therapy period in comparison to projected baseline disability progression.
Secondary outcome measures
Change in CombiWISE progression rates between baseline and monotherapy phase, monotherapy and combination therapy phase and between different drugs.
Change in the rate of ventricular atrophy between baseline, monotherapy and combination therapy periods, measured by linear regression slopes of greater than or equal to 3 time-points for each period
Correlations between change(s) in CSF biomarkers and clinical efficacy (systems biology approach analyzing drugs/combinations separately and combining all drugs/combinations to a single larger cohort; exploratory analysis)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: MonotherapyExperimental Treatment4 Interventions
Any of the study Interventions
Group II: Combination TherapyExperimental Treatment4 Interventions
Any two-drug combination of study interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dantrolene
2007
Completed Phase 2
~50
Pirfenidone
2006
Completed Phase 3
~2630
Pioglitazone
2005
Completed Phase 4
~27720
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,484,987 Total Patients Enrolled
16 Trials studying Multiple Sclerosis
4,044 Patients Enrolled for Multiple Sclerosis
Bibiana Bielekova, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
6 Previous Clinical Trials
2,714 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
2,638 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition has worsened by at least 0.5 points/year over 1.5 years.I am not allergic to Dantrolene, have no liver problems, and no history of liver issues caused by drugs or alcohol.I am not allergic to Pirfenidone, do not have liver disease, my liver tests are normal, and I do not smoke.My disability level is moderate to severe but I can still perform some daily activities.I have a health condition that needs ongoing treatment with drugs that affect the immune system.I don't have heart failure, bladder cancer, type 1 diabetes, allergies to Pioglitazone, or take Aubagio.I am not allergic to Clemastine and have a nerve test showing slow signals.I am willing to keep my current FDA-approved MS treatment stable during the study.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Therapy
- Group 2: Monotherapy
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.
What does Pioglitazone typically aim to alleviate?
"Pioglitazone is used to treat diabetes, and has also proven efficacious in managing multiple sclerosis, catarrh, and exercise-induced conditions."
Answered by AI
What other investigations have been conducted relating to the efficacy of Pioglitazone?
"Currently, 48 studies are being conducted surrounding Pioglitazone. Of these trials, 6 have reached the third phase of testing. Milan is the epicentre for this research; however, 89 additional sites are participating in running trials on its efficacy."
Answered by AI
Are any slots available to participate in this trial currently?
"Correct. According to information posted on clinicaltrials.gov, this research project is actively seeking participants for enrollment. It was originally announced on August 11th 2017 and the latest update was made November 19th 2022; with a total of 250 patients needed from one location."
Answered by AI
What is the scope of enrolment for this experiment?
"Affirmative. The information hosted on clinicaltrials.gov affirms that this research is currently recruiting patients, having been first posted on August 11th 2017 and last revised November 19th 2022. 250 participants must be selected from a single site for the trial to take place as planned."
Answered by AI
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