Phase 3 Study of Dexpramipexole in ALS (EMPOWER)
This study is ongoing, but not recruiting participants.
Sponsor:
Biogen Idec
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01281189
First received: January 20, 2011
Last updated: November 16, 2012
Last verified: November 2012
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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).
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis |
Drug: Dexpramipexole Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
U.S. FDA Resources
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- A joint rank of functional outcomes adjusted for mortality. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to death or respiratory insufficiency [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Time to death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Respiratory decline: time to reach less than or equal to 50% of predicted upright SVC or death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Change in muscle strength measurements (MSM), as determined by the overall megascore for hand-held dynamometry (HHD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Population pharmacokinetics. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Incidence of adverse events, serious adverse events, vital signs, clinical laboratory assessments, physical examination, electrocardiogram tests, and body weight. [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
| Enrollment: | 943 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281189
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| United States, Arizona | |
| Barrow Neurological Institute - St. Joseph's Hospital | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| University of California at San Francisco - Fresno | |
| Fresno, California, United States | |
| University of California, Irvine | |
| Orange, California, United States | |
| University of California, Davis | |
| Sacramento, California, United States, 95817 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| United States, Connecticut | |
| Hospital for Special Care | |
| New Britain, Connecticut, United States, 06053 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| University of Miami Miller School of Medicine | |
| Miami, Florida, United States, 33136 | |
| University of South Florida Medical Center | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Maryland | |
| Johns Hopkins University School of Medicine | |
| Baltimore, Maryland, United States | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Charlestown, Massachusetts, United States, 02129 | |
| United States, Michigan | |
| St. Mary's Health Care | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Minnesota | |
| Hennepin County Medical Center | |
| Minneapolis, Minnesota, United States, 55404 | |
| Mayo Clinic - Rochester | |
| Rochester, Minnesota, United States | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Neurology Associates, P.C. | |
| Lincoln, Nebraska, United States, 68506 | |
| United States, Nevada | |
| University of Nevada School of Medicine | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| Research Foundation of the State University of New York | |
| Syracuse, New York, United States | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28207 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States | |
| Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Providence ALS Center | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Penn State Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States | |
| ALS Center at Penn | |
| Philadelphia, Pennsylvania, United States | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Texas Neurology | |
| Dallas, Texas, United States, 75214 | |
| Methodist Neurological Institute | |
| Houston, Texas, United States, 77030 | |
| University of Texas Health Sciences Center | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Australia, New South Wales | |
| Prince of Wales Hospital | |
| Randwick, New South Wales, Australia | |
| Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Royal Brisbane and Women's Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Australia, Victoria | |
| Calvary Health Care Bethlehem | |
| Melbourne, Victoria, Australia, 3121 | |
| Belgium | |
| AZ St-Lucas | |
| Gent, Belgium, 9000 | |
| UZ Leuven | |
| Leuven, Belgium, 3000 | |
| Canada, Alberta | |
| Univ of Calgary / Foothills MC | |
| Calgary, Alberta, Canada, T2V 1P9 | |
| Canada, Quebec | |
| CHUM - Hopital Notre Dame | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Mcgill University | |
| Montreal, Quebec, Canada, H3A 2B4 | |
| Canada | |
| London Health Sciences Centre | |
| London, Canada | |
| Sunnybrook and Women's College and Health Sciences Centre | |
| Toronto, Canada, M4N 3M5 | |
| University of British Columbia | |
| Vancouver, Canada | |
| France | |
| CHRU de Lille - Hôpital Roger Salengro | |
| Lille, France, 59037 | |
| CHU de Limoges - Hôpital Dupuytren | |
| Limoges, France | |
| Centre Hospitalier La Timone | |
| Marseille, France | |
| CHU Gui de Chauliac | |
| Montpellier, France, 34295 | |
| CHU de Nice - Hôpital de l'Archet 1 | |
| Nice, France | |
| Hôpital La Pitié Salpétrière | |
| Paris, France, 75013 | |
| Germany | |
| Charité - Universitätsmedizin Berlin | |
| Berlin, Germany | |
| Bergmannsheil Gmbh | |
| Bochum, Germany | |
| Medizinische Hochschule Hannover (MHH) | |
| Hannover, Germany | |
| Universitätsklinikum Jena | |
| Jena, Germany | |
| University of Ulm, RKU | |
| Ulm, Germany | |
| Ireland | |
| Beaumont Hospital | |
| Dublin, Ireland, Dublin 9 | |
| Netherlands | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| UMC St. Radboud | |
| Nijmegen, Netherlands, 6525 GA | |
| Universitair Medisch Centrum Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Spain | |
| Hospital Vall d'Hebron | |
| Barcelona, Spain | |
| Hospital Universitario de Bellvitge | |
| Barcelona, Spain, 8907 | |
| Hospital La Paz | |
| Madrid, Spain, 28046 | |
| Hospital Carlos III | |
| Madrid, Spain | |
| Sweden | |
| Sahlgrenska Universitetssjukhuset | |
| Göteborg, Sweden, 41345 | |
| Karolinska Universitetssjukhuset, Solna | |
| Stockholm, Sweden, 17176 | |
| United Kingdom | |
| Queen Elizabeth Hospital | |
| Birmingham, United Kingdom, B15 2TH | |
| Walton Centre for Neurology & Neurosurgery | |
| Liverpool, United Kingdom, L9 7LJ | |
| Kings College Hospital NHS Foundation Trust | |
| London, United Kingdom, SE5 8AF | |
| Newcastle University Hospital - Clinical Ageing Research Unit | |
| Newcastle, United Kingdom, NE4 5PL | |
| John Radcliffe Hospital | |
| Oxford, United Kingdom | |
| Sheffield Institute for Transnational Neuroscience | |
| Sheffield, United Kingdom, S10 2HQ | |
Sponsors and Collaborators
Biogen Idec
More Information
No publications provided
| Responsible Party: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT01281189 History of Changes |
| Other Study ID Numbers: | 223AS302, EUDRA CT NO: 2010-022818-19 |
| Study First Received: | January 20, 2011 |
| Last Updated: | November 16, 2012 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products France: Agency for the Safety of drug and health products Australia: Therapeutic Goods Administration (TGA) Spain: Spanish Agency for Medicines and Health Products Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Ireland: Irish Medicines Board Sweden: Medical Products Agency Germany: Federal Institute for Drugs and Medical Devices Canada: Health Canada United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Biogen Idec:
|
Amyotrophic Lateral Sclerosis ALS Motor Neurone Disease |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes Pramipexol |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 23, 2013