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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01281189 |
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Date of registration:
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20/01/2011 |
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Primary sponsor: |
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Public title:
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Phase 3 Study of Dexpramipexole in ALS
EMPOWER |
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Scientific title:
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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 |
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Date of first enrolment:
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March 2011 |
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Target sample size:
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943 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01281189 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Belgium
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Canada
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France
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Germany
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Ireland
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Netherlands
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Spain
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Sweden
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Dexpramipexole
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Drug: Placebo
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Primary Outcome(s)
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A joint rank of functional outcomes adjusted for mortality.
[Time Frame: 12 months]
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Secondary Outcome(s)
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Change in ALS-related health quality, as measured by change in the total score on the Amyotrophic Lateral Sclerosis Assessment Questionnaire-5-Item Form (ALSAQ-5)
[Time Frame: 12 months]
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Change in muscle strength measurements (MSM), as determined by the overall megascore for hand-held dynamometry (HHD)
[Time Frame: 12 months]
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Incidence of adverse events, serious adverse events, vital signs, clinical laboratory assessments, physical examination, electrocardiogram tests, and body weight.
[Time Frame: 18 Months]
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Population pharmacokinetics.
[Time Frame: 18 months]
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Respiratory decline: time to reach less than or equal to 50% of predicted upright SVC or death
[Time Frame: 18 months]
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Time to death
[Time Frame: 18 months]
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Time to death or respiratory insufficiency
[Time Frame: 18 months]
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Secondary ID(s)
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223AS302
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EUDRA CT NO: 2010-022818-19
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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