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Could a common blood pressure pill ease muscle stiffness? early trial launches

NCT ID NCT07075965

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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