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Study of ATX-01 in Participants With DM1 | Clinical Trials | Clareo Health

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RECRUITINGPhase 1/2NCT06300307

Study of ATX-01 in Participants With DM1

The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated. The trial will comp...

Lead sponsor: ARTHEx Biotech S.L.•5 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Project Manager

CONTACT

+34676229821 clinical@arthexbiotech.com

Sponsors

Lead Sponsor

ARTHEx Biotech S.L.

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Participants with a documented clinical diagnosis of DM1 (CTG expansion of \>150 repeats in DMPK gene measured in peripheral blood mononuclear cells)
•Ambulatory, defined as able to complete a 10-meter walk/run test at screening without the use of assistive devices such as canes, walkers, or orthoses, except for ankle-foot orthoses
•Presence for \>3 seconds of grip myotonia as confirmed by a central reader

Exclusion Criteria

•Participants with congenital DM1
•Medical Research Council Muscle Scale score of less than 4 on ankle dorsiflexion or significant tibialis anterior atrophy that prevents a muscle biopsy
•Use of mexiletine or other agent for myotonia within 21 days or 5 half-lives, whichever is longer, prior to screening

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 10, 2026Terms

Trial snapshot

StatusRECRUITING

PhasePHASE1/PHASE2

Enrollment56

Start dateOct 2024

Last updatedFeb 10, 2026

Condition

Myotonic Dystrophy 1

Locations shown

UCLA

Los Angeles, California

University of Florida

Gainesville, Florida

University of Iowa Health Care - Department of Neurology

Iowa City, Iowa

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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