Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04768972 · ClinicalTrials.gov registry record · Phase 3
FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)
A Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by Ionis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
- 20
- Study locations
NCT04768972 is a Phase 3 study of Amyotrophic Lateral Sclerosis that is active but no longer recruiting, run by Ionis Pharmaceuticals. The registered enrollment target is 89 participants, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT04768972, a Phase 3 study of Amyotrophic Lateral Sclerosis, is active but no longer recruiting, sponsored by Ionis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study is to evaluate the efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ION363
Study Locations (20)
Other
- PSEG Centro de Pesquisa Clinica S.A. - São Paulo
- Universitaetsmedizin Rostock - Rostock
- Universitätsklinikum Ulm - Ulm
- St. James Hospital - Dublin
- Citta della Salute e della Scienza di Torino - Ospedale le Molinette - Torino
- Toho University Omori Medical Center - Tokyo
- Universitair Medisch Centrum Utrecht - Utrecht
- Linden spólka z ograniczona odpowiedzialnoscia spólka komandytow - Krakow
- Seoul National University Hospital - Seoul
- Hanyang University Seoul Hospital - Seoul
California
- University of California San Diego - La Jolla
- Stanford University Medical Center - Palo Alto
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Missouri
- Washington University School of Medicine - St Louis
New York
- Columbia University Medical Center - New York
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04768972
The ClinicalTrials.gov registry entry for NCT04768972 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (90% lower). The listed sponsor is Ionis Pharmaceuticals, which has 76 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.
NCT04768972 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT04768972 about?
NCT04768972 is a clinical study titled "FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)". The primary purpose of this study is to evaluate the efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS).
What is the current status of trial NCT04768972?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2021-06-14. Estimated completion is 2028-03.
What conditions does trial NCT04768972 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT04768972?
The interventions under investigation include: Placebo (DRUG), ION363 (DRUG).
Who is sponsoring clinical trial NCT04768972?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04768972 being conducted?
This trial has 20 study locations across California, Maryland, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
RECRUITING · Phase 3
-
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
RECRUITING · Phase 3
-
Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment
ACTIVE NOT RECRUITING · Phase 3
-
Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
COMPLETED · Phase 3
-
An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)
COMPLETED · Phase 3
-
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
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.