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Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)

NCT00647296 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2021-07-08

Study results available
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Summary

This was a 2-part study of dexpramipexole in patients with ALS.

Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, and clinical effects of oral administration of 3 dosage levels of dexpramipexole vs. placebo for 12 weeks.

Part 2 was a randomized, double-blind, 2-arm, parallel group, extension study evaluating the safety, tolerability, and clinical effects of oral administration of 2 dosage levels of dexpramipexole for up to 72 weeks.

Conditions

Interventions

DRUG

Placebo

Placebo: 2 tablets taken orally twice daily

DRUG

Dexpramipexole 50 mg/day

Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily

DRUG

Dexpramipexole 150 mg/day

Dexpramipexole: 2 x 37.5 mg tablets taken orally twice daily

DRUG

Dexpramipexole 300 mg/day

Dexpramipexole: 2 x 75 mg tablets taken orally twice daily

Sponsors & Collaborators

  • Knopp Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-09
Primary Completion
2009-07-31
Completion
2009-09-04

Countries

  • United States

Study Locations

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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 NCT00647296 on ClinicalTrials.gov