Status:
UNKNOWN
Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS
Lead Sponsor:
Innobioscience SpA
Collaborating Sponsors:
Pontificia Universidad Catolica de Chile
University of Chile
Conditions:
Primary Progressive Multiple Sclerosis
Multiple Sclerosis, Secondary Progressive
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
1. Evaluate the clinical efficacy of andrographolide 140 mg administered orally twice a day versus a placebo in: * Delay in the disability capacity progression through the Expanded Disability Stat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2017
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02273635
Start Date
September 1 2014
End Date
April 1 2017
Last Update
October 27 2014
Active Locations (1)
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1
Multiple Sclerosis Centre, Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile, 8330033