Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and safety of andrographolide 140 mg administered twice a day orally versus a placebo as a modifying treatment of the disease in patients with the progressive forms of Multiple Sclerosis (MS).

The principal outcome is to determine the efficacy, of andrographolide in retarding the progression of brain atrophy in patients with progressive forms of MS.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innobioscience SpA
• Collaborators: Pontificia Universidad Catolica de Chile; Universidad Austral de Chile; University of Chile
• Treatments: Andrographolide

Criteria

Inclusion Criteria:

• Signed Informed Consent previous to the initiation of the study before any evaluation.

• Men and women > 18 years of age with Minimental > 24.

• Patients with diagnosis of secondary progressive MS without relapses or primary progressive MS according to the criteria of McDonald 2010.

Exclusion Criteria:

• Relapsing-remitting MS

• Current Immunomodulatory or immunosuppressive therapy

• Uncontrolled systemic diseases not controlled or treated with immunotherapy (i.e Rheumatoid Arthritis, Lupus Erythematosus).

• Pregnant women