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Phase 3 Study of Dexpramipexole in ALS (EMPOWER)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dexpramipexole
Placebo
Sponsored by
Knopp Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, ALS, Motor Neurone Disease, Motor Neuron Disease, Lou Gehrig's disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barrow Neurological Institute - St. Joseph's Hospital
  • University of Arkansas for Medical Sciences
  • University of California at San Francisco - Fresno
  • University of California, Irvine
  • University of California, Davis
  • California Pacific Medical Center
  • Hospital for Special Care
  • Mayo Clinic - Jacksonville
  • University of Miami Miller School of Medicine
  • University of South Florida Medical Center
  • Emory University
  • Northwestern University
  • Indiana University
  • University of Iowa
  • University of Kansas Medical Center
  • Johns Hopkins University School of Medicine
  • Massachusetts General Hospital
  • St. Mary's Health Care
  • Hennepin County Medical Center
  • Mayo Clinic - Rochester
  • Washington University School of Medicine
  • Neurology Associates, P.C.
  • University of Nevada School of Medicine
  • Dartmouth-Hitchcock Medical Center
  • Columbia University
  • Research Foundation of the State University of New York
  • Carolinas Medical Center
  • Duke University Medical Center
  • Wake Forest University
  • The Cleveland Clinic Foundation
  • Ohio State University
  • Providence ALS Center
  • Penn State Hershey Medical Center
  • ALS Center at Penn
  • Drexel University College of Medicine
  • University of Pittsburgh Medical Center
  • Vanderbilt University Medical Center
  • Texas Neurology
  • Methodist Neurological Institute
  • University of Texas Health Sciences Center
  • University of Utah
  • University of Virginia Health System
  • University of Washington
  • Prince of Wales Hospital
  • Westmead Hospital
  • Royal Brisbane and Women's Hospital
  • Calvary Health Care Bethlehem
  • AZ St-Lucas
  • UZ Leuven
  • Univ of Calgary / Foothills MC
  • CHUM - Hopital Notre Dame
  • Mcgill University
  • London Health Sciences Centre
  • Sunnybrook and Women's College and Health Sciences Centre
  • University of British Columbia
  • CHRU de Lille - Hôpital Roger Salengro
  • CHU de Limoges - Hôpital Dupuytren
  • Centre Hospitalier La Timone
  • CHU Gui de Chauliac
  • CHU de Nice - Hôpital de l'Archet 1
  • Hôpital La Pitié Salpétrière
  • Charité - Universitätsmedizin Berlin
  • Bergmannsheil Gmbh
  • Medizinische Hochschule Hannover (MHH)
  • Universitätsklinikum Jena
  • University of Ulm, RKU
  • Beaumont Hospital
  • Academisch Medisch Centrum
  • UMC St. Radboud
  • Universitair Medisch Centrum Utrecht
  • Hospital Universitario de Bellvitge
  • Hospital Vall d'Hebron
  • Hospital La Paz
  • Hospital Carlos III
  • Sahlgrenska Universitetssjukhuset
  • Karolinska Universitetssjukhuset, Solna
  • Queen Elizabeth Hospital
  • Walton Centre for Neurology & Neurosurgery
  • Kings College Hospital NHS Foundation Trust
  • Newcastle University Hospital - Clinical Ageing Research Unit
  • John Radcliffe Hospital
  • Sheffield Institute for Transnational Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexpramipexole

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Composite Assessment of Function and Survival (CAFS) at 12 Months
The Composite Assessment of Function and Survival (CAFS) is a between-group comparison of a single ranked clinical outcome based on (1) the change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) score and (2) time to death. Each subject is ranked according to time-to-death (earlier deaths ranked lower than later deaths). Subjects who survive are ranked more favorably than subjects who died. Among the survivors, subjects are ranked according to change in ALSFRS-R (greater worsening of ALSFRS-R is ranked lower than less worsening or an improvement in ALSFRS-R). The ranked scores range from 001 to 941 (the number of subjects in the Efficacy Population) with larger rank score numbers associated with a better outcome. The ranks were analyzed using an ANCOVA model, which includes treatment as a fixed effect and adjusts for baseline ALSFRS-R score, duration of symptoms, site of onset, and use of riluzole. The least square mean rank score is presented for each treatment group.
Death up to 12 Months (CAFs Individual Component)
The longest duration of follow-up for this time to the death analysis was 12 months. In the study, subjects were followed for 12-18 months.
Change From Baseline in ALSFRS-R at 12 Months (CAFs Individual Component)
The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48, with higher scores representing better function.

Secondary Outcome Measures

Death or Respiratory Insufficiency (DRI) up to Month 18
Time to Death or Respiratory Insufficiency (DRI) is defined as receipt of a tracheostomy or the use of non-invasive ventilation (NIV) for ≥22 hours per day for at least 10 consecutive days. If NIV is used to meet the criteria for respiratory insufficiency, no measured slow vital capacity (SVC) at any subsequent assessment may be >50%. Time to DRI is calculated from the date of the first dose to the first date of one of the following events: death, tracheostomy, or the 10th day of consecutive NIV with no measured SVC >50% at any subsequent assessment.
Death up to 18 Months
Estimated time to death up to 18 months. This includes deaths reported greater than 30 days following discontinuation from the study (the time period for reporting all-cause mortality), regardless of subject disposition, up to 18 months from first dose.
≤50% Predicted Upright Slow Vital Capacity (SVC) or Died up to 18 Months
The date of reaching ≤50% of predicted upright slow vital capacity (SVC) is defined as the date of the first visit at which a predicted upright SVC is ≤50% and continues to remain ≤50% at the subsequent visit except for the last available observation. The time to reach ≤50% of predicted upright SVC is defined as the duration between the date of reaching ≤50% of predicted upright SVC and the date of the first dose of study medication. If the subject is alive and does not reach ≤50% of predicted upright SVC, the time to reach ≤50% of predicted upright SVC will be censored and equal to the number of days from the first dose of study medication until the visit date when the subject's last available SVC assessment is performed. The earliest time (Reaching ≤50% Predicted Upright SVC or death) is used in analysis.

Full Information

First Posted
January 20, 2011
Last Updated
May 10, 2021
Sponsor
Knopp Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT01281189
Brief Title
Phase 3 Study of Dexpramipexole in ALS
Acronym
EMPOWER
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 Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Knopp Biosciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, ALS, Motor Neurone Disease, Motor Neuron Disease, Lou Gehrig's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
942 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexpramipexole
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexpramipexole
Other Intervention Name(s)
KNS-760704, BIIB050
Intervention Description
Oral tablet 150mg twice daily for up to 18 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet twice daily for up to 18 months.
Primary Outcome Measure Information:
Title
Composite Assessment of Function and Survival (CAFS) at 12 Months
Description
The Composite Assessment of Function and Survival (CAFS) is a between-group comparison of a single ranked clinical outcome based on (1) the change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) score and (2) time to death. Each subject is ranked according to time-to-death (earlier deaths ranked lower than later deaths). Subjects who survive are ranked more favorably than subjects who died. Among the survivors, subjects are ranked according to change in ALSFRS-R (greater worsening of ALSFRS-R is ranked lower than less worsening or an improvement in ALSFRS-R). The ranked scores range from 001 to 941 (the number of subjects in the Efficacy Population) with larger rank score numbers associated with a better outcome. The ranks were analyzed using an ANCOVA model, which includes treatment as a fixed effect and adjusts for baseline ALSFRS-R score, duration of symptoms, site of onset, and use of riluzole. The least square mean rank score is presented for each treatment group.
Time Frame
12 months
Title
Death up to 12 Months (CAFs Individual Component)
Description
The longest duration of follow-up for this time to the death analysis was 12 months. In the study, subjects were followed for 12-18 months.
Time Frame
12 months
Title
Change From Baseline in ALSFRS-R at 12 Months (CAFs Individual Component)
Description
The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48, with higher scores representing better function.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Death or Respiratory Insufficiency (DRI) up to Month 18
Description
Time to Death or Respiratory Insufficiency (DRI) is defined as receipt of a tracheostomy or the use of non-invasive ventilation (NIV) for ≥22 hours per day for at least 10 consecutive days. If NIV is used to meet the criteria for respiratory insufficiency, no measured slow vital capacity (SVC) at any subsequent assessment may be >50%. Time to DRI is calculated from the date of the first dose to the first date of one of the following events: death, tracheostomy, or the 10th day of consecutive NIV with no measured SVC >50% at any subsequent assessment.
Time Frame
18 months
Title
Death up to 18 Months
Description
Estimated time to death up to 18 months. This includes deaths reported greater than 30 days following discontinuation from the study (the time period for reporting all-cause mortality), regardless of subject disposition, up to 18 months from first dose.
Time Frame
18 months
Title
≤50% Predicted Upright Slow Vital Capacity (SVC) or Died up to 18 Months
Description
The date of reaching ≤50% of predicted upright slow vital capacity (SVC) is defined as the date of the first visit at which a predicted upright SVC is ≤50% and continues to remain ≤50% at the subsequent visit except for the last available observation. The time to reach ≤50% of predicted upright SVC is defined as the duration between the date of reaching ≤50% of predicted upright SVC and the date of the first dose of study medication. If the subject is alive and does not reach ≤50% of predicted upright SVC, the time to reach ≤50% of predicted upright SVC will be censored and equal to the number of days from the first dose of study medication until the visit date when the subject's last available SVC assessment is performed. The earliest time (Reaching ≤50% Predicted Upright SVC or death) is used in analysis.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merit Cudkowicz, MD, MSc
Organizational Affiliation
Professor of Neurology of the Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute - St. Joseph's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California at San Francisco - Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Hospital for Special Care
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06053
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of South Florida Medical Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
St. Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Neurology Associates, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
University of Nevada School of Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Research Foundation of the State University of New York
City
Syracuse
State/Province
New York
ZIP/Postal Code
12201
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Providence ALS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
ALS Center at Penn
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Neurology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Methodist Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Calvary Health Care Bethlehem
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
AZ St-Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Univ of Calgary / Foothills MC
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
CHUM - Hopital Notre Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Mcgill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
London Health Sciences Centre
City
London
Country
Canada
Facility Name
Sunnybrook and Women's College and Health Sciences Centre
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
Country
Canada
Facility Name
CHRU de Lille - Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Limoges - Hôpital Dupuytren
City
Limoges
Country
France
Facility Name
Centre Hospitalier La Timone
City
Marseille
Country
France
Facility Name
CHU Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nice - Hôpital de l'Archet 1
City
Nice
Country
France
Facility Name
Hôpital La Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Bergmannsheil Gmbh
City
Bochum
Country
Germany
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
Country
Germany
Facility Name
University of Ulm, RKU
City
Ulm
Country
Germany
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
Dublin 9
Country
Ireland
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Carlos III
City
Madrid
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset, Solna
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Walton Centre for Neurology & Neurosurgery
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Kings College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Facility Name
Newcastle University Hospital - Clinical Ageing Research Unit
City
Newcastle
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
Country
United Kingdom
Facility Name
Sheffield Institute for Transnational Neuroscience
City
Sheffield
ZIP/Postal Code
S10 2HQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24067398
Citation
Cudkowicz ME, van den Berg LH, Shefner JM, Mitsumoto H, Mora JS, Ludolph A, Hardiman O, Bozik ME, Ingersoll EW, Archibald D, Meyers AL, Dong Y, Farwell WR, Kerr DA; EMPOWER investigators. Dexpramipexole versus placebo for patients with amyotrophic lateral sclerosis (EMPOWER): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2013 Nov;12(11):1059-67. doi: 10.1016/S1474-4422(13)70221-7. Epub 2013 Sep 23. Erratum In: Lancet Neurol. 2013 Nov;12(11):1042. Carbonell, J G [corrected to Gamez, J].
Results Reference
derived

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Phase 3 Study of Dexpramipexole in ALS

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