Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 3 Extension Study of Dexpramipexole in ALS (ENVISION)

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: NCT01622088
Recruitment Status : Terminated (The Initial Phase 3 Study (NCTO1281189) did not meet its primary efficacy endpoint.)
First Posted : June 18, 2012
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Knopp Biosciences

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Dexpramipexole 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 collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 616 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis
Study Start Date : June 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013


Arm Intervention/treatment
Experimental: Dexpramipexole Drug: Dexpramipexole
Oral tablet 150 mg given twice daily up to 36 months




Primary Outcome Measures :
  1. Incidence of Adverse Events and Serious Adverse Events [ Time Frame: 36 months ]
  2. Discontinuation of study treatment due to an Adverse Events [ Time Frame: 36 months ]
  3. Changes in vital signs, clinical laboratory assessments (hematology, blood chemistry, and urinalysis), 12-lead electrocardiogram (ECGs), and body weight [ Time Frame: 36 months ]
  4. Incidence of laboratory abnormalities [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Change in Amyotrophic Lateral Sclerosis Functional Rating Scale (revised) (ALSFRS-R) score [ Time Frame: 36 months ]
  2. Decline in sniff nasal inspiratory pressure (SNIP) [ Time Frame: 36 months ]
  3. Time to death [ Time Frame: 36 months ]
  4. Time to death or death equivalent (tracheostomy or permanent assisted ventilation (PAV), defined as use of noninvasive ventilation (NIV) for ≥ 22 hours per day for ≥ 10 days) [ Time Frame: 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT01622088


  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Barrow Neurological Institute - St. Joseph's Hospital
Phoenix, Arizona, United States, 85013
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
Saint 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
ALS Center at Penn
Philadelphia, Pennsylvania, United States
Drexel University College of Medicine
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
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 Universitario de Bellvitge
Barcelona, Spain, 8907
Hospital Vall d'Hebron
Barcelona, Spain
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
Knopp Biosciences
Biogen

Layout table for additonal information
Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT01622088     History of Changes
Other Study ID Numbers: 223AS304
EUDRA CT #: 2011-006119-70
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Keywords provided by Knopp Biosciences:
ALS, Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents