INS1202 for Amyotrophic Lateral Sclerosis (ALS)

A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)

Recruiting Phase 1 Interventional Study
Amyotrophic Lateral Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 79
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
23 (estimated)
Sponsor
Insmed Gene Therapy LLC · Industry
Who this trial is looking for

This trial is looking for adults aged 18 to 79 with ALS. Participants will receive a single injection of INS1202 and we will observe how safe it is and how it affects their condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have a body mass index (BMI) of 18 or higher.
  • I have been diagnosed with ALS.
  • I have a positive test for a SOD1 mutation or no known ALS-related genetic mutation.
  • I have a score of 24 or higher on the ALSFRS-R assessment.
  • My ALS symptoms started no more than 42 months ago.

You may not be able to join if

  • I have received cellular or gene therapies for ALS before.
  • I am currently taking any experimental medications for ALS or other conditions.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: - * 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…
Contacts

Insmed Medical Information

1-844-446-7633

medicalinformation@insmed.com

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