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

NCT02273635 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2014-10-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Andrographolides

140 mg andrographolides coated tablets twice a day orally administered for 24 months.

DRUG

placebo

140 mg excipients coated tablets twice a day orally administered for 24 months

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    collaborator OTHER

  • University of Chile

    collaborator OTHER

  • Universidad Austral de Chile

    collaborator OTHER

  • Innobioscience SpA

    lead INDUSTRY

Principal Investigators

  • Juan L Hancke, DVM, PhD · Universidad Austral de Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-11-30
Completion
2017-04-30

Countries

  • Chile

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02273635 on ClinicalTrials.gov