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Phase 3 Extension Study of Dexpramipexole in ALS (ENVISION)

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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

Tracking Information
First Submitted Date  ICMJE May 3, 2012
First Posted Date  ICMJE June 18, 2012
Last Update Posted Date December 15, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2013)
  • Incidence of Adverse Events and Serious Adverse Events [ Time Frame: 36 months ]
  • Discontinuation of study treatment due to an Adverse Events [ Time Frame: 36 months ]
  • Changes in vital signs, clinical laboratory assessments (hematology, blood chemistry, and urinalysis), 12-lead electrocardiogram (ECGs), and body weight [ Time Frame: 36 months ]
  • Incidence of laboratory abnormalities [ Time Frame: 36 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
  • Incidence of AEs and SAEs [ Time Frame: 36 months ]
  • Discontinuation of study treatment due to an AE [ Time Frame: 36 months ]
  • Changes in vital signs, clinical laboratory assessments (hematology, blood chemistry, and urinalysis), 12-lead ECGs, and body weight [ Time Frame: 36 months ]
  • Incidence of laboratory abnormalities [ Time Frame: 36 months ]
Change History Complete list of historical versions of study NCT01622088 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2013)
  • Change in Amyotrophic Lateral Sclerosis Functional Rating Scale (revised) (ALSFRS-R) score [ Time Frame: 36 months ]
  • Decline in sniff nasal inspiratory pressure (SNIP) [ Time Frame: 36 months ]
  • Time to death [ Time Frame: 36 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
  • Change in ALSFRS-R score [ Time Frame: 36 months ]
  • Decline in SNIP [ Time Frame: 36 months ]
  • Time to death [ Time Frame: 36 months ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Extension Study of Dexpramipexole in ALS
Official Title  ICMJE An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE Drug: Dexpramipexole
Oral tablet 150 mg given twice daily up to 36 months
Study Arms  ICMJE Experimental: Dexpramipexole
Intervention: Drug: Dexpramipexole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 20, 2013)
616
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2012)
603
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Ireland,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01622088
Other Study ID Numbers  ICMJE 223AS304
EUDRA CT #: 2011-006119-70
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Knopp Biosciences
Study Sponsor  ICMJE Knopp Biosciences
Collaborators  ICMJE Biogen
Investigators  ICMJE Not Provided
PRS Account Knopp Biosciences
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP