Denver, CONCT03981575Now EnrollingIRB Ready

Myotonic Dystrophy 1 Clinical Trial in Denver, CO

Access cutting-edge myotonic dystrophy 1 treatment through this clinical trial at a research site in Denver. Study-provided care at no cost to qualified participants.

Sponsored by Virginia Commonwealth University

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Expert Care in Denver

Access myotonic dystrophy 1 specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related myotonic dystrophy 1 treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Denver

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Denver site if eligible
  4. 4Begin participation

About This Myotonic Dystrophy 1 Study in Denver

Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN), the present study seeks to overcome insufficient data on natural history; lack of reliable biomarkers; and incomplete characterization and limited biological understanding of the phenotypic heterogeneity of Myotonic Dystrophy 1 by examining strategies to improve the reliability by making further refinements in our sample collection and analysis procedures by developing strategies for managing patient heterogeneity going forward. Funding Source- FDA OOPD

Sponsor: Virginia Commonwealth University

Who Can Participate

Inclusion Criteria

Age 18 to 70 (inclusive)
Competent to provide informed consent
Clinical diagnosis of DM1 based on research criteria1 or positive genetic test
Comment: The clinical research criteria require myotonia, muscle weakness in a characteristic distribution, and history of similar findings in a first degree relative. Genetic testing confirmed the diagnosis of DM1 in \> 99% of individuals who satisfied these criteria.2

Exclusion Criteria

Symptomatic renal or liver disease, uncontrolled diabetes or thyroid disorder, or active malignancy other than skin cancer.
Current alcohol or substance abuse
Concurrent enrollment in clinical trial for DM1, or participation in trial within 6 months of entry.
Concurrent pregnancy or planned pregnancy during the course of the study.
Concurrent medical condition that would, in the opinion of the investigator or clinical evaluator, compromise performance on study measures.
Note: non-ambulatory participants are not excluded, but are limited to \<15% of enrollment. Inclusion criteria for participants in the muscle biopsy sub-study: • Of the 95 patients undergoing the tibialis anterior muscle biopsy, at least half will have at least moderate weakness of ankle dorsiflexion, defined as MRC score ≤ 4+. This is in order to obtain a muscle tissue sample in a person more severely affected with myotonic dystrophy. Approximately 10 patients at each site will undergo the muscle biopsy. Exclusion criteria for 95 participants in the muscle biopsy sub-study:
Known CTG repeat expansion size less than 100 repeats, unless there are clear cut signs of limb weakness and muscle wasting. This is in order to obtain a muscle tissue sample in a person more severely affected with myotonic dystrophy.
Use of anticoagulant such as warfarin or a direct oral anticoagulant (e.g. dabigatran) due to the increased risk of bleeding.
Use of aspirin or non-steroidal anti-inflammatory agents should be discontinued 3 days prior to the biopsy procedure, if possible.
Platelet count \<50,000 (if known) due to the increased risk of bleeding.
History of a bleeding disorder due to the increased risk of bleeding.
Advanced wasting of tibialis anterior (TA) muscle that precludes needle muscle biopsy in order to ensure that a sample taken would be of muscle and not just fat and fascia.
Previous muscle biopsy of either TA in order to provide muscle tissue samples of non-biopsied muscles.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Denver?

Yes, this clinical trial (NCT03981575) has an active research site in Denver, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Myotonic Dystrophy 1 Treatment Options in Denver, CO

If you're searching for myotonic dystrophy 1 treatment options in Denver, CO, this clinical trial (NCT03981575) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Denver research site is actively enrolling participants for this clinical trial. You'll receive care from experienced myotonic dystrophy 1 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all myotonic dystrophy 1 clinical trials near you to find additional studies recruiting in your area.

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