Phase 3 Study of Dexpramipexole in ALS

Conditions	Phase	Intervention Type
ALS	Phase 3	Drug Dexpramipexole Drug Placebo

View trial NCT01281189 on www.clinicaltrials.gov

Contacts

Please use the information below to contact the trial coordinators.

Eligibility

Ages Eligible for Study: 18 years to 80 years
Genders Eligible for Study: Both

Keywords

Amyotrophic Lateral Sclerosis, ALS, and Motor Neurone Disease

Inclusion Criteria

- Aged 18 to 80 years old, inclusive, on Day 1.

- Diagnosis of sporadic or familial ALS.

- Onset of first ALS symptoms within 24 months prior to Day 1.

- World Federation of Neurology El Escorial criteria are met for a possible,
laboratory-supported probable, probable, or definite ALS diagnosis.

- Upright slow vital capacity (SVC) of 65% or more at screening.

- Patients taking or not taking Riluzole are eligible for this study: if a patient has
never taken Riluzole, he or she is eligible; if a patient is currently taking
Riluzole, he or she must have been on a stable dose for at least 60 days; if a
patient has discontinued Riluzole, he or she must have stopped taking it for at least
30 days.

- Must be able to swallow tablets at the time of study entry.

Exclusion Criteria

may apply.

Detailed Description

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281189

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas United States
(Not yet recruiting)
University of California at San Francisco - Fresno

Fresno, California United States
(Not yet recruiting)
University of California, Irvine

Orange, California United States
(Not yet recruiting)
Johns Hopkins University School of Medicine

Baltimore, Maryland United States
(Not yet recruiting)
Mayo Clinic - Rochester

Rochester, Minnesota United States
(Not yet recruiting)
Research Foundation of the State University of New York

Syracuse, New York United States
(Recruiting)

See 76 more locations