Clinical trial
An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study…
NCT02623699 · Biogen, Industry · Completed
Key facts
| NCT number | NCT02623699 |
|---|---|
| Title | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) |
| Official 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 |
| Acronym | VALOR (Part C) |
| Lead sponsor | Biogen, Industry |
| Collaborators | Ionis Pharmaceuticals, Inc. Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Amyotrophic Lateral Sclerosis |
| Intervention type | Drug |
| Interventions | Tofersen, Placebo |
| Enrollment | 176 |
| Start date | Jan 20, 2016 |
| Primary completion | Jul 16, 2021 |
| Completion | Jul 16, 2021 |
| First posted | Dec 8, 2015 |
| Last update posted | Jul 28, 2023 |
| Countries | Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Poland, South Korea, United Kingdom, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: