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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 29 July 2022
Main ID:  NCT02623699
Date of registration: 24/11/2015
Prospective Registration: Yes
Primary sponsor: Biogen
Public title: An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) VALOR (Part C)
Scientific title: A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects With Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation
Date of first enrolment: January 20, 2016
Target sample size: 178
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02623699
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Australia Belgium Canada Denmark France Germany Italy Japan
Korea, Republic of Poland Sweden United Kingdom United States
Contacts
Name:     Medical Director
Address: 
Telephone:
Email:
Affiliation:  Biogen
Key inclusion & exclusion criteria
Health Condition(s) or Problem(s) studied
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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