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NCT07259980 · ClinicalTrials.gov registry record
A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD-1) Amyotrophic Lateral Sclerosis (ALS)
A clinical trial, sponsored by Biogen.
- Recruiting
- Registry status
- 125
- Enrollment target
NCT07259980 is a clinical trial that is actively recruiting participants, run by Biogen. The registered enrollment target is 125 participants.
The verdict
NCT07259980 is actively recruiting participants, sponsored by Biogen.
- RECRUITING
- Registry status
- 125 participants
- Enrollment target
Study Summary
In this study, researchers will learn more about the safety of tofersen, also known as Qalsody®. This is a drug available for doctors to prescribe for participant with a certain type of amyotrophic lateral sclerosis, also known as ALS. This type is in participant who have a mutation in the superoxide dismutase 1 gene, also known as SOD-1. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will be found using 2 different groups of study research centers that help provide clinical care for participant with ALS. These groups are in Europe and the United States and are called: * the Precision-ALS programme * the ALS/Motor Neuron Disease (MND) Natural History Consortium (NHC) The main goal of this study is to collect safety information in participants with SOD-1 ALS who were in either of the groups. The main question researchers want to answer in this study is: * What are the characteristics of the participants in this study? * How many participants had serious adverse events (SAEs), including ones that affect the brain, spinal cord, or nerves? An adverse event is a health problem that may or may not be caused by a drug during the study. An adverse event is considered serious when it results in death, is life-threatening, causes lasting problems, or requires hospital care. Researchers will also learn more about: * How many participants develop other health conditions or become pregnant, including how the pregnancy turned out * Why and when participants stopped treatment This study will be done as follows: * Participants will be screened to check if they can join the study. * Data from the participants' regular visits to their clinic will be collected based on which study research center they are in. * Each participant will be in the study until they decide to leave or until death. Currently, the study is planned to last at least 7 years.
Interventions
- DRUG Tofersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2026-01-02 |
| Est. Completion | 2033-12-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07259980
The ClinicalTrials.gov registry entry for NCT07259980 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tofersen is the first listed.
NCT07259980 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07259980 about?
NCT07259980 is a clinical study titled "A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD-1) Amyotrophic Lateral Sclerosis (ALS)". In this study, researchers will learn more about the safety of tofersen, also known as Qalsody®. This is a drug available for doctors to prescribe for participant with a certain type of amyotrophic lateral sclerosis, also known as ALS. This type is in participant who have a mutation in the superoxid...
What is the current status of trial NCT07259980?
This trial is currently recruiting. The enrollment target is 125 participants. The study started on 2026-01-02. Estimated completion is 2033-12-30.
What interventions are being tested in trial NCT07259980?
The interventions under investigation include: Tofersen (DRUG).
Who is sponsoring clinical trial NCT07259980?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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