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NCT02623699 · ClinicalTrials.gov registry record · Phase 3
An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)
A Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 176
- Enrollment target
- 20
- Study locations
NCT02623699: Completed Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by Biogen.
NCT02623699 is a Phase 3 study of Amyotrophic Lateral Sclerosis that has completed, run by Biogen. The registered enrollment target is 176 participants, below the 896-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02623699, a Phase 3 study of Amyotrophic Lateral Sclerosis, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 176 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objectives of Parts A and B of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of tofersen in adults with ALS and a documented superoxide dismutase 1 (SOD1) mutation. The primary objective of Part C of this study is to evaluate the clinical efficacy of tofersen administered to adults with ALS and a confirmed SOD1 mutation. The secondary objective of Parts A and B of this study is to evaluate the effects of tofersen on levels of total SOD1 protein in the cerebrospinal fluid (CSF). The secondary objectives of Part C are to evaluate the safety, tolerability, pharmacodynamic (PD), and biomarker effects of tofersen.
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE is any untoward
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tofersen
Study Locations (20)
Florida
- Mayo Clinic in Florida - Jacksonville
- University of Miami School of Medicine - Miami
- Bioclinica Research - Orlando
California
- University of California San Diego Medical Center - La Jolla
- California Pacific Medical Center - San Francisco
Arizona
- Barrow Neurological Institute - Phoenix
Georgia
- Emory University Hospital - Atlanta
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2016-01-20 |
| Est. Completion | 2021-07-16 |
| Phase | Phase 3 |
What the finished NCT02623699 record still lists
NCT02623699 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 896-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02623699 names 20 study sites across 17 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT02623699 about?
NCT02623699 is a clinical study titled "An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)". The primary objectives of Parts A and B of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of tofersen in adults with ALS and a documented superoxide dismutase 1 (SOD1) mutation. The primary objective of Part C of this study is to evaluate the clinic...
What is the current status of trial NCT02623699?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 176 participants. The study started on 2016-01-20. Estimated completion is 2021-07-16.
What conditions does trial NCT02623699 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT02623699?
The interventions under investigation include: Placebo (DRUG), Tofersen (DRUG).
Who is sponsoring clinical trial NCT02623699?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02623699 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02623699's enrollment target sits among peer trials
176 31st of 102 higher than 72 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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