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NCT03867435 · ClinicalTrials.gov registry record
Assessing Clinical Endpoints and Biomarkers in Myotonic Dystrophy Type-1 and Type 2 (ASCEND-DM)
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Terminated
- Registry status
- 4
- Enrollment target
NCT03867435: Clinical Trial study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT03867435 is a clinical trial that was terminated before completion, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03867435 was terminated before completion, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- TERMINATED
- Registry status
- 4 participants
- Enrollment target
Study Summary
Background: Myotonic dystrophy is a long-term genetic disorder that affects muscle function. Symptoms include gradually worsening muscle loss and weakness. Muscles often contract and cannot relax. Researchers want to find out how various tests for DM1 or DM2 change over 2 years, to help them develop better tests for people with these diseases. Data and samples from this study will be shared with the Myotonic Dystrophy Clinical Research Network (DMCRN) investigators participating in the ongoing Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (ENDDM1) study Objective: To find better ways to assess how myotonic dystrophy type 1 or type 2 affects people. Eligibility: People ages 11 70 with DM1 or DM2 Design: Participants will have 3 study visits over 2 years. Participants may be admitted to the clinic. Each visit may last up to a week and will include: Medical history and physical exam Blood, heart, and pregnancy tests Questions about their disease Breathing and muscle tests, including tests of movement, grip, and hand opening Speech and swallowing exam Magnetic resonance imaging (MRI). Participants will lie on a table that slides into a cylinder. A magnetic field and radio waves will take pictures of the body. They may do a task during the scan. They may have a dye injected. Pictures of chemicals in the brain or muscle taken in an MRI scanner Thinking and memory tests Sleep studies. Electrodes placed on the scalp will record the electrical activity of the brain. Other devices on the body will measure heartbeat, breathing, movement, and oxygen. Tests of electrical activity of muscles. Participants move their arms and legs with disks stuck on their skin. Visits may also include: Exam by a physician expert in stomach and bowel disorders A piece of muscle and/or spinal fluid removed by needle Sponsoring Institute: National Institute of Neurological Disorders and Stroke ...
Primary Outcome
strength of handgrip by hand-held force transducer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-02-24 |
| Est. Completion | 2021-11-02 |
Why NCT03867435 stopped before completion
NCT03867435 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03867435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03867435 about?
NCT03867435 is a clinical study titled "Assessing Clinical Endpoints and Biomarkers in Myotonic Dystrophy Type-1 and Type 2 (ASCEND-DM)". Background: Myotonic dystrophy is a long-term genetic disorder that affects muscle function. Symptoms include gradually worsening muscle loss and weakness. Muscles often contract and cannot relax. Researchers want to find out how various tests for DM1 or DM2 change over 2 years, to help them develo...
What is the current status of trial NCT03867435?
This trial is currently terminated. The enrollment target is 4 participants. The study started on 2020-02-24. Estimated completion is 2021-11-02.
Who is sponsoring clinical trial NCT03867435?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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