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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis

 
Study Focus:
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).
Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS
Study Category:
Drug Trial
Study Status:
Closed
Study Results:
http://www.thelan...970221-7/abstract http://www.alscon...elease_biogen.php
Phase:
Phase III
Type:
Interventional Trial
with active agents/drugs & a placebo
Funding Source:
Biogen Idec
Study Chair(s)/Principal Investigator(s):
Medical Director EMPOWER Study, Biogen Idec
Clinicaltrials.gov ID:
NCT01281189
NEALS Affiliated?
Yes
Study Summary:
Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, degenerative disease of motor neurons in the brain and spinal cord that leads to muscle atrophy and spasticity in limb and bulbar muscles resulting in weakness and loss of ambulation, oropharyngeal dysfunction, weight loss, and ultimately respiratory failure. The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of ALS.

# of Subjects:
804
Enrollment Start Date:
03/01/2011
Posting Last Modified Date:
01/01/2013
Date Study Added to alsconsortium.org:
11/02/2011
Eligibility Criteria
Gender:
Male & Female
Minimum Age:
18
Maximum Age:
80
Min Vital Capacity (% predicted normal):
65%
Time since Symptom Onset:
Less than 24 months
Time since Diagnosis:
Not applicable
Can participants use Riluzole?
Yes
Coordinating Center
Contact Information
Biogen Idec
UNITED STATES
Other Eligibility Criteria:
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:

Other medically significant illness.
Clinically significant abnormal laboratory values.
Pregnant women or women breastfeeding.
Prior exposure to dexpramipexole.
Currently taking pramipexole or other dopamine agonists.
Other protocol-defined inclusion/exclusion criteria may apply.

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