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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 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.

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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.

Conditions Studied

Amyotrophic Lateral Sclerosis

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

FieldValue
Enrollment Target 176 participants
Start Date 2016-01-20
Est. Completion 2021-07-16
Phase Phase 3

Sponsor

Biogen

334 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02623699

The ClinicalTrials.gov registry entry for NCT02623699 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 896-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (80% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.