Efficacy, safety and tolerability of IB-MS versus placebo in patients with progressive forms of MS: preliminary results from a phase II, randomized, placebo-controlled, double blind, proof of concept study
ECTRIMS Online Library. Ciampi E. Oct 12, 2018; 232042; 289
Ethel Ciampi
Ethel Ciampi
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Abstract: 289

Type: Scientific Session

Abstract Category: Therapy - Others

Introduction: A number of effective treatments have emerged for treating relapsing-remitting MS, with less impressive results in patients with progressive forms (PrMS). IB-MS is a labdane dipertene isolated from a medicinal plant that has been proposed effective in the treatment of autoimmune diseases.
Objective: To compare the efficacy and safety of IB-MS versus placebo in patients with inactive PrMS.
Methods: Patients with clinical/radiological inactive PrMS, >18 years old, without disease modifying therapy for at least 6 months, EDSS < 8 and MMSE >24 were randomly assigned to IB-MS 140 mg po twice a day or placebo. The main outcome was to determine the efficacy of IB-MS in reducing brain atrophy as measured by SIENA over a period of 24 months with an estimated sample size of 68 patients. Secondary outcomes included Expanded Disability Status Scale (EDSS), cognitive assessment, fatigue, and quality of life. Safety, tolerability and adverse events were also assessed. The study was approved by Ethical Committee from Ministry of Health Chile and registered at NCT02273635.
Results: Forty-three patients were recruited (23 IB-MS, 20 placebo) in a single center, and 29 patients (17 IB-MS, 12 placebo) completed the study with the two time-point MRI. Percentage Brain Volume Change was -2.0%+1.1 in the IB-MS and -2.2%+1.3 in the placebo group (p=0.8). IB-MS group had a lower 24 month mean EDSS compared to placebo (p=0.036). Placebo group had 41.6% of patients with confirmed disability progression, compared to 29.4% in the IB-MS group (p=0.02). Adverse events included disgeusia, mild rash, herpetic encephalitis, and acute coronary syndrome in the IB-MS, and sepsis, depressión and acute coronary syndrome in the placebo group.
Conclusions: Clinical studies in PrMS patients represent a huge challenge for clinical research with limited resources. Although we were not able to achieve our primary endpoint nor achieve our expected sample size, progression and disability outcomes suggest a potential role of IB-MS in reducing neurodegeneration in inactive PrMS. Tolerability and safety seem comparable between the groups. Larger multicenter studies are still needed to determine the magnitude of the contribution of IB-MS in reducing neurodegeneration.
Disclosure: Ethel Ciampi nothing to disclose
Claudia Carcamo nothing to disclose
Juan Hancke received consulting fees from InnoBioscience SpA
Rafael Burgos received consulting fees from InnoBioscience SpA
Ana Reyes nothing to disclose
Diego Reyes nothing to disclose
Carmen Pinto nothing to disclose
Macarena Vásquez nothing to disclose

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