Could a common blood pressure pill ease muscle stiffness? early trial launches
NCT ID NCT07075965
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests amlodipine, a calcium channel blocker used for high blood pressure, in 20 adults with myotonic dystrophy type 1. The goal is to see if the drug is safe and can improve muscle strength, reduce stiffness, and help with daily function. All participants will take the drug for 10 weeks, with some getting a higher dose after the first month. Results will guide a larger future study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amlodipine (a calcium channel blocker, commonly used for high blood pressure)
- What this could lead to
- If safe and effective, this could point toward a treatment to improve muscle strength and reduce stiffness in people with myotonic dystrophy type 1.
- What could go wrong
- This is a very early Phase 1 trial with only 20 people, focused on safety. It may not show clear benefit, and side effects like low blood pressure or dizziness are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or Female between the ages 18 and 65, inclusive. * A genetically confirmed diagnosis of DM1, having a repeat expansion in the DMPK gene with at least 100 CTG repeats. * Grip strength less than 50% predicted based on age, height, and sex. * Video hand opening time is 4 sec or greater for at least one hand. * Ambulatory and able to walk 10 meters. * Willingness to discontinue anti-myotonia drugs at least 2 weeks prior to screening. * Highly effective method of contraception in women with childbearing potential. Exclusion Criteria: * Congenital DM1 as defined by symptom onset in the first 4 weeks of life. * Abnormal liver function tests (LFTs): alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \>3 x upper limit of normal. Total bilirubin \> 1.5 mg/dL, or INR \> 1.3, or evidence of current active or chronic infection with hepatitis C, hepatitis B or other hepatobiliary conditions other than DM1 (or attributed to DM1) that cause abnormal liver laboratory parameters (e.g., hemochromatosis, Wilson's disease, autoimmune hepatitis) * Current or recent infection requiring antibiotic treatment within 2 weeks prior to screening. * Abnormal vital signs, including systolic blood pressure \< 90 mmHg and diastolic blood pressure \< 60 mmHg. * Treatment with concomitant medications with potential interactions with amlodipine, these may include but are not limited to sildenafil, cyclosporin, atorvastatin at high dosages (80 mg daily), simvastatin (at dosages higher than 20 mg daily) or strong inhibitors of CYP3A4. * A history of syncope. * A history of symptomatic hypotension. * Initiation or change in doses of concomitant medications, including herbal supplements, if in the opinion of the Investigator, may impact the results of the study. * Women of childbearing potential must have a negative pregnancy test, cannot be planning a pregnancy, and cannot be breastfeeding at any time during the study. * Known history of substance and/or alcohol abuse within one year prior to screening. * The presence of comorbidities that, in the opinion of the Investigator, may influence study results, including, but not limited to, uncontrolled diabetes, generalized or mononeuropathy of the upper extremities, or cervical radiculopathy resulting in weakness and atrophy. * Concurrent treatment with calcium channel blocker. * Known ischemic or non-ischemic moderate or severe heart failure as defined by symptoms suggestive of heart failure or reduced left ventricular ejection fraction (LVEF) on echocardiogram \< 55%. * Moderate or severe aortic stenosis or other obstruction of the left ventricle outflow tract. * Known sensitivity or allergy to amlodipine.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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