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Study on the Effectiveness and Safety of Losmapimod for Patients with Facioscapulohumeral Muscular Dystrophy (FSHD)

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Losmapimod on a condition known as Facioscapulohumeral Muscular Dystrophy (FSHD). FSHD is a genetic disorder that causes progressive muscle weakness, particularly affecting the face, shoulders, and upper arms. The study aims to evaluate how effective and safe Losmapimod is in treating patients with this condition. Losmapimod is taken in the form of tablets, and some participants will receive a placebo, which looks like the medication but does not contain the active ingredient.

The study is designed to last for 48 weeks, during which participants will be randomly assigned to receive either Losmapimod or a placebo. This is a double-blind study, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The main goal is to see if Losmapimod can slow down the progression of muscle weakness in FSHD patients. Participants will have regular check-ups to monitor their health and any changes in their condition.

In addition to assessing the effectiveness of Losmapimod, the study will also focus on its long-term safety and how well patients tolerate the medication. This will involve regular assessments of participants’ overall health, including laboratory tests, heart monitoring through ECGs, and physical examinations. The study will help determine if Losmapimod can be a beneficial treatment option for those living with FSHD.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either the active medication, losmapimod, or a placebo. The placebo is designed to look like the losmapimod tablets but does not contain the active ingredient.

The study is double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

2 medication administration

The patient will take the assigned tablets orally. If receiving losmapimod, the dosage is 15 mg per tablet.

The medication will be taken as directed by the study protocol, which typically involves a regular schedule over the course of the study.

3 study duration

The study is divided into two parts: Part A and Part B.

Part A lasts for 48 weeks, during which the patient will be monitored for changes in their condition and any side effects.

If the patient completes Part A, they may continue to Part B, which focuses on the long-term safety and tolerability of losmapimod.

4 monitoring and assessments

Throughout the study, the patient will undergo regular assessments to monitor the progression of their condition and the effects of the treatment.

These assessments may include physical examinations, laboratory tests, and other evaluations to ensure the patient’s safety and to measure the effectiveness of the treatment.

5 completion of the study

At the end of the study, the patient will have a final assessment to evaluate the overall impact of the treatment.

The study is expected to conclude by May 31, 2027, at which point all data will be analyzed to determine the efficacy and safety of losmapimod for treating facioscapulohumeral muscular dystrophy.

Who Can Join the Study?

  • The patient must sign and date an informed consent form, which is a document that explains the study and confirms their willingness to participate.
  • The patient must have a diagnosis of Facioscapulohumeral Muscular Dystrophy (FSHD), confirmed by genetic testing. FSHD is a genetic muscle disorder.
  • The patient must have a Clinical Severity Score between 2 and 4. This score measures the severity of the disease, with 0 being no symptoms and 5 being the most severe. Patients who need a wheelchair or walker cannot join the study.
  • The patient must have a specific range of muscle strength in their dominant arm, measured by a test called RWS. This test checks how well the muscles work without any weight.
  • The patient must be willing and able to attend scheduled visits and follow the treatment plan and other study procedures.
  • The patient must not have any reasons that prevent them from having an MRI, which is a type of scan that takes pictures of the inside of the body.
  • The patient must be between 18 and 65 years old.
  • Female patients who can have children must use a highly effective method to prevent pregnancy during the study and for 90 days after the last dose of the study drug. This includes methods like surgery to prevent pregnancy or being postmenopausal, which means not having periods for 12 months for reasons other than medical conditions.
  • Male patients must agree to use a method of contraception during the study and for 90 days after the last dose of the study drug.
  • For Part B of the study, the patient must have completed 48 weeks of treatment in Part A.
  • The patient must agree to follow the study’s rules, including visits, treatment plans, and laboratory tests.

Who Cannot Join the Study?

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of heart problems or uncontrolled high blood pressure.
  • Patients who have a history of liver or kidney disease.
  • Patients who have a history of mental health disorders that are not well controlled.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nice Nice France
Rigshospitalet Copenhagen Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Cpxofo Cdhqdtc Ngki Milan Italy
Lqxon Uncgttzqdctq Mqhcioc Csjrsng (zqxej Leiden The Netherlands
Sphgygrsq Rpafvhw Utargnsblj Mctmhin Cpqkog Nijmegen The Netherlands
Atdxuj Ulhlfapdiw Huurzwcw Aarhus Denmark
Hqdhrhgf Ujigfbqourlii Dwmodgfh Donostia / San Sebastian Spain
Kpmyduty dwl Ugdattqugjli Mjafvirb Aye Munich Germany
Hcvizazq Viqq djwvivfo Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
31.08.2022
France France
Not recruiting
31.08.2022
Germany Germany
Not recruiting
31.08.2022
Italy Italy
Not recruiting
31.08.2022
Spain Spain
Not recruiting
31.08.2022
The Netherlands The Netherlands
Not recruiting
31.08.2022

Trial locations

Investigated drugs:

Losmapimod is a medication being studied for its potential to treat patients with Facioscapulohumeral Muscular Dystrophy (FSHD). The trial aims to evaluate how effective losmapimod is in slowing down the progression of the disease. It also looks at the long-term safety and how well patients can tolerate the medication.

Investigated diseases:

Facioscapulohumeral Muscular Dystrophy – This is a genetic muscle disorder characterized by progressive muscle weakness and wasting. It primarily affects the muscles of the face, shoulders, and upper arms, leading to difficulties in facial expressions, lifting objects, and raising the arms. The progression of muscle weakness can vary significantly among individuals, with some experiencing mild symptoms and others facing more severe muscle loss. Over time, the weakness may extend to other muscle groups, including those in the lower body. The onset of symptoms typically occurs in adolescence or early adulthood, but it can also appear later in life. The rate of progression is generally slow, allowing individuals to adapt to changes over time.

Trial ID:
2024-512737-33-00
Protocol code:
1821-FSH-301
NCT ID:
NCT05397470
Trial Phase:
Therapeutic confirmatory (Phase III)

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