EUCTR2016-003225-41-IT
Active, not recruiting
Phase 1
An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation - na
ConditionsAmyotrophic Lateral Sclerosis (ALS)MedDRA version: 20.0Level: PTClassification code 10077024Term: Familial amyotrophic lateral sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Sponsor
- BIOGEN IDEC RESEARCH LIMITED
- Enrollment
- 182
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Must have diagnosis of SOD1\-ALS, and must have completed the End of
- •Study Visit for either Parts A, Band/or C of Study 233AS101 (i.e., were
- •not withdrawn).
- •\- If taking riluzole, must be receiving a stable dose for \=30 days prior to
- •Day 1 and expected to remain at that dose until the final study visit.
- •\- For female participants of childbearing potential must agree to practice
- •effective contraception during the study and for 5 months after their last
- •dose of study treatment.
- •\- Medically able to undergo the study procedures, and to adhere to the
- •visit schedule at the time of study entry, as determined by the
Exclusion Criteria
- •\- History of allergies to a broad range of anaesthetics.
- •\- Presence of risk for increased or uncontrolled bleeding and/or risk of
- •bleeding that is not managed optimally and could place a participant at
- •an increased risk for bleeding during or after an LP procedure. These
- •risks could include, but are not limited to, anatomical factors at or near
- •the LP site (e.g., vascular abnormalities, neoplasms, or other
- •abnormalities) and underlying disorders of the coagulation cascade,
- •platelet function, or platelet count (e.g., hemophilia, Von Willebrand's
- •disease, liver disease).
- •\- Presence of an implanted shunt for the drainage of CSF or an implanted
Outcomes
Primary Outcomes
Not specified
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