Actively Recruiting

Phase 2
All Genders
NCT07220603

An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)

Led by PepGen Inc · Updated on 2026-03-30

48

Participants Needed

3

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to learn about the long-term safety and tolerability of PGN-EDODM1 in participants with myotonic dystrophy type 1 (DM1) who have completed a prior study with PGN-EDODM1.

CONDITIONS

Official Title

An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant has completed a prior study with PGN-EDODM1
Not Eligible

You will not qualify if you...

  • Abnormal laboratory tests at screening considered clinically significant by the Investigator
  • Use of an investigational drug (other than PGN-EDODM1), device, or product, within 30 days or 5 half-lives of the study drug (whichever is longer) prior to study entry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Calgary

Calgary, Alberta, Canada, T2N 4Z6

Actively Recruiting

2

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Actively Recruiting

3

CIUSSS du Saguenay-Lac-Saint-Jean

Saguenay, Canada

Actively Recruiting

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Research Team

P

PepGen Patient Advocacy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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