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Phase 3 Study of Dexpramipexole in ALS (EMPOWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01281189
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Knopp Biosciences

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Dexpramipexole Drug: Placebo Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 943 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis
Study Start Date : March 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dexpramipexole Drug: Dexpramipexole
Oral tablet 150mg twice daily for up to 18 months.
Other Name: BIIB050
Placebo Comparator: Placebo Drug: Placebo
Oral tablet twice daily for up to 18 months.


Outcome Measures
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Primary Outcome Measures :
  1. A joint rank of functional outcomes adjusted for mortality. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Time to death or respiratory insufficiency [ Time Frame: 18 months ]
  2. Time to death [ Time Frame: 18 months ]
  3. Respiratory decline: time to reach less than or equal to 50% of predicted upright slow vital capacity (SVC) or death [ Time Frame: 18 months ]
  4. Change in muscle strength measurements (MSM), as determined by the overall megascore for hand-held dynamometry (HHD) [ Time Frame: 12 months ]
  5. 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 ]
  6. Population pharmacokinetics. [ Time Frame: 18 months ]
  7. Incidence of adverse events, serious adverse events. [ Time Frame: 18 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281189


Locations
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Sponsors and Collaborators
Knopp Biosciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT01281189    
Other Study ID Numbers: 223AS302
EUDRA CT NO: 2010-022818-19
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Keywords provided by Knopp Biosciences:
Amyotrophic Lateral Sclerosis
ALS
Motor Neurone Disease
Additional relevant MeSH terms:
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Pramipexole
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
 Proteostasis Deficiencies
Metabolic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents