A Multicenter Randomized Double Blind Placebo Controlled Parallel Group Pilot Study to Assess the Efficacy and Safety of H.P. Acthar Gel in Subjects with Relapsing-remitting Multiple Sclerosis
Investigating the Safety and Tolerability of an Investigational Medication in Relapsing-Remitting Multiple Sclerosis (RRMS)
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: relapsing-remitting multiple sclerosis
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Must have a diagnosis of RRMS
Must have had a relapse with onset less than or equal to 25 days prior to the Baseline Visit
Must have started treatment with 3 tp 5 days of 1 g per day of IVMP, 1,250 mg per day or oral prednisone, or 1,000 mg per day or oral methylprenisolone within 10 days of the onset of the first relapse symptom
Exclusion Criteria
History of use of Acthar for the treatment of MS
Has only sensory, bowel/bladder, and/or cognitive symptoms of MS associated with the most recent relapse
Unwilling to receive, or is intolerant of, SC injections
History of sensitivity to ACTH preparations or to porcine protein products
Has been treated with ocrelizumab, daclizumab, natalizumab, alemtuzumab, or any immunosuppressants in the 6 months prior to the Screening Visit or throughout the study
History of chronic active hepatitis
History of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection
Has type 1 or type 2 diabetes mellitus
This study investigates the safety and tolerability of an investigational medication in individuals with Relapsing-Remitting Multiple Sclerosis (RRMS). RRMS is a type of multiple sclerosis characterized by periods of new or increasing neurological symptoms followed by periods of partial or complete recovery. The study focuses on participants who have not responded well to high-dose intravenous or oral steroid treatments.
Participants will receive the investigational medication and will be monitored for their response to the treatment. The study will assess how well the medication is tolerated and whether it is safe for use in people with RRMS. Participants will be compensated for their time and involvement in the study.
- Who can participate: Adults diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) who have relapsed within 25 days before the study may qualify. Participants must have previously received specific steroid treatments and should not have used the investigational medication for MS treatment.
- Study details: Participants will receive subcutaneous injections of an investigational medication. A placebo is not used in this study. Participants' responses to the treatment will be monitored to determine its safety and tolerability.
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