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Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study

Name: Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study — clinical trial record (NCT06649955)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: CALM

StatusRecruiting

PhaseNot applicable

SponsorPathMaker Neurosystems Inc.

Started2025-02-10

View on ClinicalTrials.gov ↗

Following completion of the ALS Early Feasibility Study of the MyoRegulator® device for treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the MyoRegulator® device to treat ALS in an expanded number of individuals with ALS. CALM will gather additional preliminary evidence of clinical safety and potential effectiveness in this patient population with a longer follow-up period and additional secondary endpoints in a single-arm study prior to commencing a larger sham-controlled pivotal trial.

Amendment history 2 changes detected by DataLookout

2026-09-11

Primary completion pushed: 2026-06 → 2026-10

2026-09-11

Completion pushed: 2026-11 → 2027-02

Trial Details

NCT Number	NCT06649955
Lead Sponsor	PathMaker Neurosystems Inc. Collaborators: Beth Israel Deaconess Medical Center, United States Department of Defense
Conditions	ALS - Amyotrophic Lateral Sclerosis
Enrollment	15 participants
Start Date	2025-02-10
Primary Completion	2026-10 (estimated)
Study Completion	2027-02 (estimated)
Updated on ClinicalTrials.gov	2026-09-10