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Phase 3 Study of Dexpramipexole in ALS

NCT01281189 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 942

Last updated 2021-06-07

Study results available
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Summary

The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).

Conditions

Interventions

DRUG

Dexpramipexole

Oral tablet 150mg twice daily for up to 18 months.

DRUG

Placebo

Oral tablet twice daily for up to 18 months.

Sponsors & Collaborators

  • Knopp Biosciences

    lead INDUSTRY

Principal Investigators

  • Merit Cudkowicz, MD, MSc · Professor of Neurology of the Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Netherlands
  • Spain
  • Sweden
  • 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 NCT01281189 on ClinicalTrials.gov