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Phase 3 Extension Study of Dexpramipexole in ALS

NCT01622088 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 616

Last updated 2022-05-03

Study results available
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Summary

The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

Conditions

Interventions

DRUG

Dexpramipexole

Oral tablet 150 mg given twice daily (BID)

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Knopp Biosciences

    lead INDUSTRY

Principal Investigators

  • Michael Bozik, MD · Knopp Biosciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01622088 on ClinicalTrials.gov