Phase 3 Study of Dexpramipexole in ALS (EMPOWER)
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ClinicalTrials.gov Identifier: NCT01281189 |
Recruitment Status :
Completed
First Posted : January 21, 2011
Last Update Posted : December 15, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole Drug: Placebo | Phase 3 |
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 |

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. |
- A joint rank of functional outcomes adjusted for mortality. [ Time Frame: 12 months ]
- Time to death or respiratory insufficiency [ Time Frame: 18 months ]
- Time to death [ Time Frame: 18 months ]
- Respiratory decline: time to reach less than or equal to 50% of predicted upright slow vital capacity (SVC) or death [ Time Frame: 18 months ]
- Change in muscle strength measurements (MSM), as determined by the overall megascore for hand-held dynamometry (HHD) [ Time Frame: 12 months ]
- 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 ]
- Population pharmacokinetics. [ Time Frame: 18 months ]
- Incidence of adverse events, serious adverse events. [ Time Frame: 18 Months ]

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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 |
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.

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

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 |
Amyotrophic Lateral Sclerosis ALS Motor Neurone Disease |
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 |