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A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo

NCT02284568 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2022-03-10

Study results available
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Summary

This Phase 2 study is intended to serve as a proof of concept for potential treatment with laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod in this population.

Conditions

Interventions

DRUG

Placebo

Placebo

DRUG

Laquinimod

Laquinimod capsules in 0.5 mg and 0.6 mg strengths

DRUG

Placebo

Placebo capsules

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-12
Primary Completion
2017-05-04
Completion
2017-10-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • Ukraine
  • United Kingdom

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 NCT02284568 on ClinicalTrials.gov