Phase 3 Study of Dexpramipexole in ALS (EMPOWER)

Phase 3 Study of Dexpramipexole in ALS (EMPOWER)

Quick Info:

Status:
Not Yet Recruiting
Estimated Enrollment:
804
Phase:
III
Treatment Type:
Orally available in pill form
Trial Type:
Double Blind Placebo Controlled
Sponsor:
Biogen Idec
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
>= 60%
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
< 30
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
YES
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
NO
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

There are no update notes for this clinical trial.

Locations:

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Other Information:

Purpose: 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).
Eligibility: 18 years to 80 years. Both genders. Not accepting healthy volunteers.
Details: Dexpramipexole oral tablet 150mg twice daily for up to 18 months ; Placebo oral tablet twice daily for up to 18 months.
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 1/20/2011
ClinicalTrials.gov ID: NCT01281189
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov