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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
Must not have
Clinically significant medical disorders, other than MS, that require chronic treatment with immunosuppressive or immunomodulatory agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests four different drugs, alone or in combination, on adults with progressive multiple sclerosis who are not responding well to current treatments. The goal is to see if these drugs can reduce harmful inflammation and immune activity in the brain and spinal fluid.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a health condition that needs ongoing treatment with drugs that affect the immune system.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
will be change in CombiWISE progression rate at the end of monotherapy plus combination therapy period in comparison to projected baseline disability progression.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
2014
Completed Phase 2
~180
Pirfenidone
2006
Completed Phase 3
~2600
Pioglitazone
2005
Completed Phase 4
~27720
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) such as beta interferons, glatiramer acetate, natalizumab, and dimethyl fumarate. Beta interferons work by reducing inflammation and modulating the immune response.
Glatiramer acetate mimics myelin basic protein, distracting the immune system from attacking myelin. Natalizumab blocks the movement of immune cells across the blood-brain barrier, preventing them from reaching the central nervous system.
Dimethyl fumarate activates the Nrf2 pathway, reducing oxidative stress and inflammation. These treatments are crucial for MS patients as they help to reduce the frequency and severity of relapses, slow disease progression, and minimize the development of new lesions, thereby improving quality of life.
Failed, Interrupted, or Inconclusive Trials on Immunomodulatory Treatment Strategies in Multiple Sclerosis: Update 2015-2020.
Failed, Interrupted, or Inconclusive Trials on Immunomodulatory Treatment Strategies in Multiple Sclerosis: Update 2015-2020.
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,326 Previous Clinical Trials
5,365,627 Total Patients Enrolled
16 Trials studying Multiple Sclerosis
3,992 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.
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