Phase 3 Extension Study of Dexpramipexole in ALS

NCT ID: NCT01622088

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 616 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-02-28

Brief Summary

The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

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 collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexpramipexole

Dexpramipexole open-label

Group Type: EXPERIMENTAL

Dexpramipexole

Intervention Type: DRUG

Oral tablet 150 mg given twice daily (BID)

Interventions

Dexpramipexole

Oral tablet 150 mg given twice daily (BID)

Intervention Type: DRUG

Other Intervention Names

BIIB050

Eligibility Criteria

Inclusion Criteria

• Subject has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or have the consent confirmed by a witness if unable to write) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
• Subject was enrolled in either CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
• Subject has completed their last visit in Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
• Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment.

Exclusion Criteria

• Subject withdrew prematurely from Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
• Subject permanently discontinued study treatment in Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189) for any reason other than enrollment into this study.
• Subject from Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189) has a significant change in medical history (including laboratory tests or a clinically significant condition) that in the opinion of the Investigator would impair the subject's medical fitness for participation and preclude treatment.
• Female subject who is pregnant or breastfeeding.
• Subject is currently enrolled in any investigational drug study other than Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
• Subject is taking pramipexole, other dopamine agonists, any other agent with dopaminergic activity, or any other disallowed concomitant medication.
• Subject is unwilling or unable to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol. At a minimum, subjects who are not able to travel to the study site must be willing to agree to remote blood draws for clinical laboratory evaluations and telephone visits to report Adverse Events, concomitant medications, and Amyotrophic Lateral Sclerosis Functional Rating Scale (revised) (ALSFRS-R) scores.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

Knopp Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Bozik, MD

Role: STUDY_CHAIR

Knopp Biosciences

Locations

Barrow Neurological Institute - St. Joseph's Hospital

Phoenix, Arizona, United States

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

California Pacific Medical Center

San Francisco, California, United States

Hospital for Special Care

New Britain, Connecticut, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

University of South Florida Medical Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Charlestown, Massachusetts, United States

St. Mary's Health Care

Grand Rapids, Michigan, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Neurology Associates, P.C.

Lincoln, Nebraska, United States

University of Nevada School of Medicine

Las Vegas, Nevada, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Columbia University

New York, New York, United States

Research Foundation of the State University of New York

Syracuse, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest University

Winston-Salem, North Carolina, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Providence ALS Center

Portland, Oregon, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

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

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Neurology

Dallas, Texas, United States

Methodist Neurological Institute

Houston, Texas, United States

University of Texas Health Sciences Center

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

University of Washington

Seattle, Washington, United States

Prince of Wales Hospital

Randwick, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Calvary Health Care Bethlehem

Melbourne, Victoria, Australia

AZ St-Lucas

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

Univ of Calgary / Foothills MC

Calgary, Alberta, Canada

CHUM - Hopital Notre Dame

Montreal, Quebec, Canada

Mcgill University

Montreal, Quebec, Canada

London Health Sciences Centre

London, , Canada

Sunnybrook and Women's College and Health Sciences Centre

Toronto, , Canada

University of British Columbia

Vancouver, , Canada

CHRU de Lille - Hôpital Roger Salengro

Lille, , France

Centre Hospitalier La Timone

Marseille, , France

CHU Gui de Chauliac

Montpellier, , France

CHU de Nice - Hôpital de l'Archet 1

Nice, , France

Hôpital La Pitié Salpétrière

Paris, , France

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Bergmannsheil Gmbh

Bochum, , Germany

Medizinische Hochschule Hannover (MHH)

Hanover, , Germany

Universitätsklinikum Jena

Jena, , Germany

University of Ulm, RKU

Ulm, , Germany

Beaumont Hospital

Dublin, , Ireland

Academisch Medisch Centrum

Amsterdam, , Netherlands

UMC St. Radboud

Nijmegen, , Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Hospital Universitario de Bellvitge

Barcelona, , Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital La Paz

Madrid, , Spain

Hospital Carlos III

Madrid, , Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Karolinska Universitetssjukhuset, Solna

Stockholm, , Sweden

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Walton Centre for Neurology & Neurosurgery

Liverpool, , United Kingdom

Kings College Hospital NHS Foundation Trust

London, , United Kingdom

Newcastle University Hospital - Clinical Ageing Research Unit

Newcastle, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Sheffield Institute for Transnational Neuroscience

Sheffield, , United Kingdom

Countries

United States; Australia; Belgium; Canada; France; Germany; Ireland; Netherlands; Spain; Sweden; United Kingdom

Other Identifiers

EUDRA CT #: 2011-006119-70

Identifier Type: -

Identifier Source: secondary_id

223AS304

Identifier Type: -

Identifier Source: org_study_id