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Glycogen Synthase Kinase-3 Beta Inhibitor

Tideglusib for Myotonic Dystrophy (REACH CDM X Trial)

Phase 2 & 3
Recruiting
Research Sponsored by AMO Pharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects under study must be individuals with a diagnosis of Congenital or Childhood Onset DM1
Subjects must be male or female aged ≥6 years to ≤45 years at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 68 and every 16 weeks thereafter up until discontinuation or study closure, assessed up to week 132
Awards & highlights

REACH CDM X Trial Summary

This trial is for kids with a rare muscle disorder who participated in and completed a previous study.

Who is the study for?
This trial is for individuals aged 6 to 45 with Congenital or Childhood Onset Myotonic Dystrophy, who can follow food intake rules and have a caregiver's support. It's open to those who completed the AMO-02-MD-2-003 study or are treatment naïve. Participants need confirmed genetic diagnosis and a CGI-S score of ≥3.Check my eligibility
What is being tested?
The trial tests Tideglusib's safety and effectiveness in treating Myotonic Dystrophy. It includes people from an earlier study on the same drug as well as new participants, all receiving Tideglusib in an open-label phase 2/3 setting.See study design
What are the potential side effects?
While specific side effects of Tideglusib aren't listed here, common ones may include allergic reactions (as there's mention of hypersensitivity), especially since it contains strawberry components.

REACH CDM X Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with DM1 as a child or it is a congenital condition.
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I am between 6 and 45 years old.
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My diagnosis was confirmed through genetic testing.

REACH CDM X Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 68 and every 16 weeks thereafter up until discontinuation or study closure, assessed up to week 132
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 68 and every 16 weeks thereafter up until discontinuation or study closure, assessed up to week 132 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician-Completed Congenital DM1 Rating Scale (CDM1-RS)
Safety (Adverse Events)
Safety (Adverse Events) - With Optional Expanded Access
Secondary outcome measures
10-meter walk-run test
Autism Behavior Inventory- Clinician (ABI-C)
Caregiver Completed Congenital DM1 Rating Scale (CC-CDM1-RS)
+11 more

REACH CDM X Trial Design

1Treatment groups
Experimental Treatment
Group I: TideglusibExperimental Treatment1 Intervention
Weight adjusted tideglusib, orally, once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tideglusib
2016
Completed Phase 3
~160

Find a Location

Who is running the clinical trial?

AMO Pharma LimitedLead Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled
2 Trials studying Myotonic Dystrophy
72 Patients Enrolled for Myotonic Dystrophy
Joseph P Horrigan, MDStudy DirectorAMO Pharma
1 Previous Clinical Trials
56 Total Patients Enrolled
1 Trials studying Myotonic Dystrophy
56 Patients Enrolled for Myotonic Dystrophy

Media Library

Tideglusib (Glycogen Synthase Kinase-3 Beta Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05004129 — Phase 2 & 3
Myotonic Dystrophy Research Study Groups: Tideglusib
Myotonic Dystrophy Clinical Trial 2023: Tideglusib Highlights & Side Effects. Trial Name: NCT05004129 — Phase 2 & 3
Tideglusib (Glycogen Synthase Kinase-3 Beta Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05004129 — Phase 2 & 3
Myotonic Dystrophy Patient Testimony for trial: Trial Name: NCT05004129 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other experimental treatments similar to Tideglusib?

"Tideglusib was first studied in 2021 at Children's Hospital of Eastern Ontario. There have been five completed studies since then, with three more currently underway. These trials are based out of Ottawa, Ontario."

Answered by AI

Who would be an ideal candidate to participate in this research?

"This study is looking for 56 children and adolescents with myotonic dystrophy to participate. They must be between the ages of 6 and 17 and meet the following criteria: Written, voluntary informed consent must be obtained before any study related procedures are conducted. Where a parent or LAR provides consent, there must also be assent from the subject (as required by local regulations), Subject must be willing and able to comply with the required food intake restrictions as outlined per protocol, Subjects who have completed the antecedent AMO-02-MD-2-003 study through V11, Subject's caregiver must be willing and able to support"

Answered by AI

For this particular experiment, are the participants above the age of 35 years old?

"This clinical trial is open to children aged 6-17 years old."

Answered by AI

Are people still being accepted into this program to test new treatments?

"The clinical trial mentioned is not recruiting patients at the moment. The original posting was on August 23rd, 2021, with the most recent update on November 15th, 2021. Although this particular study isn't looking for volunteers, there are 17 other trials that are."

Answered by AI

In how many different medical clinics is this scientific study being conducted today?

"This clinical trial is being conducted out of Children's Hospital of Eastern Ontario in Ottawa, Ontario, University of Iowa Hospitals and Clinics in Iowa City, Iowa, and Virginia Commonwealth University-Department of Neurology - Muscular dystrophy Translational Research Program in Richmond, Arkansas as well as 9 additional locations."

Answered by AI

Have clinical trials like this been run before?

"Tideglusib has undergone 5 clinical trials since it was first introduced in 2021. The most recent trials were completed in 2023 and involved 56 patients. The trials were sponsored by AMO Pharma Limited and took place across 13 cities and 6 countries."

Answered by AI

To date, how many people have enrolled in this research program?

"The trial isn't recruiting patients right now but was last edited on 11/15/2021. If you're looking for other studies, there are 14 clinical trials actively recruiting patients with myotonic dystrophy and 3 studies for Tideglusib actively looking for patients."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
California
What site did they apply to?
University of California, Los Angeles (UCLA)
Stanford University
Children's Hospital of Eastern Ontario
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Why did patients apply to this trial?

Tideglusib new trial. I haven’t tried any other medications. I have a cavity in my 5 teeths please find a solution to cure it naturally.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Tideglusib in Congenital or Childhood Onset Myotonic Dystrophy
2021. "Safety and Efficacy of Tideglusib in Congenital or Childhood Onset Myotonic Dystrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05004129.
~19 spots leftby Mar 2025
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