Recruiting PHASE2 Myotonic Dystrophy 1

New treatment option for Myotonic Dystrophy 1

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

ClinicalTrials.gov ID: NCT07220603

What this study is testing

What is PGN-EDODM1?

PGN-EDODM1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myotonic dystrophy 1.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Adults

You may be able to join if

  • Participant has completed a prior study with PGN-EDODM1

You likely can't join if

  • 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)...

The study team makes the final eligibility decision.

Where it's taking place

  • Calgary, Alberta, Canada
  • Ottawa, Ontario, Canada
  • Saguenay, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Calgary, Alberta, Canada; Ottawa, Ontario, Canada; Saguenay, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.