Tests INS1202 injection into the spine for amyotrophic lateral sclerosis
Tests a one-time spinal injection of INS1202 in adults with ALS.
Plain-language title generated from the registry record
Registry title: A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Key facts
- Where
- Baltimore, Columbia, Columbus, Houston, La Jolla, Palo Alto, Philadelphia, Phoenix, and Worcester, United StatesSee the 9 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 79 years old?
Source: NCT07290062, who can take part
Where in United States
- USA003Baltimore, United StatesTaking people
- USA001Columbia, United StatesTaking people
- USA007Columbus, United StatesTaking people
- USA010Houston, United StatesTaking people
- USA004La Jolla, United StatesTaking people
- USA002Palo Alto, United StatesTaking people
- USA006Philadelphia, United StatesTaking people
- USA005Phoenix, United StatesTaking people
- USA009Worcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insmed Gene Therapy LLC
- Trial code
- NCT07290062
- Record updated
- 10 November 2026
- Original description
The primary objective of this dose-finding study is to evaluate 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.Read full original descriptionShow less
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
The primary objective of this dose-finding study is to evaluate 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.
Inclusion: Participant with 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.
Exclusion: Previous treatment for ALS with cellular or gene therapies; Any investigational medication or treatment (for ALS or other condition); Note: Other protocol-defined inclusion/exclusion criteria may apply.