Phase 3 Extension Study of Dexpramipexole in ALS (ENVISION)

This study has been terminated.
(The Initial Phase 3 Study (NCTO1281189) did not meet its primary efficacy endpoint.)
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01622088
First received: May 3, 2012
Last updated: September 12, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: Dexpramipexole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

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

Secondary Outcome Measures:
  • Change in Amyotrophic Lateral Sclerosis Functional Rating Scale (revised) (ALSFRS-R) score [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Decline in sniff nasal inspiratory pressure (SNIP) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Time to death [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 616
Study Start Date: June 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexpramipexole Drug: Dexpramipexole
Oral tablet 150 mg given twice daily up to 36 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 collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622088

  Show 80 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01622088     History of Changes
Other Study ID Numbers: 223AS304, EUDRA CT #: 2011-006119-70
Study First Received: May 3, 2012
Last Updated: September 12, 2013
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
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada

Keywords provided by Biogen Idec:
ALS, Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Additional relevant 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
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 September 30, 2014