Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 1interventionalRules rewrite

Phase 1: INS1202 for Amyotrophic Lateral Sclerosis

The primary objective of this dose-finding study is to measure the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \<80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.

Official registry: https://clinicaltrials.gov/study/NCT07290062 · Insmed Gene Therapy LLC · enrollment listed as 23

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are INS1202. The registry lists allocation as randomized. The primary objective of this dose-finding study is to measure the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \<80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.

They plan to enroll about 23 people at 9 sites. Taking part typically means genetic testing or a gene-targeted therapy plus check-ins.

Official title (unrewritten)

A Phase 1, Multicenter, Open-label, Dose-Finding Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection of INS1202 in Patients With Amyotrophic Lateral Sclerosis

Interventions: INS1202

Primary outcome (registry wording): Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 79 Years
  • Participant with body mass index (body-mass index (BMI)) ≥18 kilograms per square meter (kg/m\^2)
  • Participant with symptomatic ALS as diagnosed by Gold Coast diagnostic criteria
  • Sporadic ALS cohorts: Negative testing for known monogenic mutations associated with familial ALS
  • SOD1-ALS (Cohorts 2 and 3 only): Confirmed pathogenic SOD1 mutation, with negative testing for other genetic mutations associated with familial ALS
  • Any polymorphism or mutation in the coding region will require additional review by the Sponsor to determine compatibility with the study intervention
  • Baseline ALSFRS-R ≥ 24
  • ALS disease duration ≤ 42 months

Public study contact (from the registry)

Insmed Medical Information

1-844-446-7633

medicalinformation@insmed.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

9 listed

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FAQ about this NCT record

Is NCT07290062 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07290062?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07290062?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary