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MAP Kinase Inhibitor

Losmapimod for Facioscapulohumeral Muscular Dystrophy

Phase 2

Waitlist Available

Research Sponsored by Fulcrum Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be between 18 and 65 years of age, inclusive

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 24 weeks from the date of enrollment through study completion, up to 60 months

Awards & highlights

Study Summary

This trial is studying the long-term safety of a drug for people with Facioscapulohumeral Muscular Dystrophy type 1 who participated in a previous study.

Who is the study for?

This trial is for adults aged 18-65 with Facioscapulohumeral Muscular Dystrophy (FSHD) who were in the ReDux4 study. Participants must be able to follow the study plan and use approved birth control methods. Those with illnesses that could affect results or pose risks, allergies, heart or brain diseases, other muscle disorders, or significant mental illness cannot join.Check my eligibility

What is being tested?

The trial tests Losmapimod's long-term safety and effectiveness in treating FSHD. It's an open-label extension meaning all participants know they are receiving Losmapimod and there is no placebo group involved.See study design

What are the potential side effects?

While specific side effects of Losmapimod aren't listed here, common ones may include nausea, diarrhea, headaches, fatigue or allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 24 weeks from the date of enrollment through study completion, up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 24 weeks from the date of enrollment through study completion, up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 24 weeks from the date of enrollment through study completion, up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and Tolerability of Losmapimod

Secondary outcome measures

Lean Muscle Volume

Muscle Fat Fraction

Muscle Fat Infiltration

+1 more

Other outcome measures

FSHD Health Index (FSHD-HI) - Clinical Outcome Assessment

Motor Function Measure (MFM) Domain 1 - Clinical Outcome Assessment

Muscle Strength - Clinical Outcome Assessment

+3 more

Side effects data

From 2016 Phase 2 trial • 17 Patients • NCT02000440

29%

Headache

24%

Fatigue

18%

Rash

18%

Muscle spasms

18%

Vomiting

18%

Oropharyngeal pain

18%

Blood creatinine increased

18%

Nausea

18%

Dizziness

12%

Oedema peripheral

12%

Dyspepsia

12%

Abdominal pain

12%

Blood pressure increased

12%

Upper respiratory tract infection

Proteinuria

Vitamin D decreased

Hyperglycaemia

Dysuria

Hyperhidrosis

Skin papilloma

Back pain

Nasal congestion

Decreased appetite

Animal bite

Confusional state

Anaemia

Dizziness postural

Contusion

Multiple allergies

Bronchitis

Joint stiffness

Musculoskeletal stiffness

Breast pain

Gout

Sinusitis

Eosinophils urine

Abdominal pain upper

Diarrhoea

Presyncope

Localised oedema

Ear infection

Gastroenteritis viral

Nasopharyngitis

Pneumonia

Respiratory tract infection viral

Urinary tract infection

Asthma

Cough

Epistaxis

Blood urea increased

Cystatin C increased

Flatulence

Chest discomfort

Palpitations

Ear pain

Pyrexia

Swelling

Anxiety

Blood albumin increased

100%

80%

60%

40%

20%

Study treatment Arm

Losmapimod 7.5 mg BID / 15 mg BID

Trial Design

1Treatment groups

Experimental Treatment

Group I: LosmapimodExperimental Treatment1 Intervention

FSHD1 patients with genetic confirmation will receive Losmapimod 15 mg by mouth twice daily for a total of 30 mg daily until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Losmapimod

Not yet FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fulcrum TherapeuticsLead Sponsor

7 Previous Clinical Trials

603 Total Patients Enrolled

Michelle Mellion, MDStudy DirectorFulcrum Therapeutics

3 Previous Clinical Trials

112 Total Patients Enrolled

Marie-Helene Jouvin, MDStudy DirectorFulcrum Therapeutics

3 Previous Clinical Trials

292 Total Patients Enrolled

Media Library

Losmapimod (MAP Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04264442 — Phase 2

Facioscapulohumeral Muscular Dystrophy Research Study Groups: Losmapimod

Facioscapulohumeral Muscular Dystrophy Clinical Trial 2023: Losmapimod Highlights & Side Effects. Trial Name: NCT04264442 — Phase 2

Losmapimod (MAP Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04264442 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining openings in this clinical experiment?

"Clinicaltrials.gov confirms that this trial, initially posted on 2/13/2020 and updated for the last time 11/3/2022, does not have any vacancies at this moment in time. However, there are 88 other trials recruiting patients currently."

Answered by AI

Has Losmapimod received the stamp of approval from the Food and Drug Administration?

"Our team has assigned Losmapimod a score of 2, which is reflective of the clinical data that supports its safety but lacks evidence for efficacy."

Answered by AI

Are there any participating medical facilities in this municipality that are administering the experiment?

"Our medical trial is enrolling participants at Ohio State University, University of Utah and Virginia Commonwealth University alongside 14 other research centres."

Answered by AI

Who may benefit from participating in this clinical research?

"This medical trial is seeking to enrol 76 individuals between 18 and 65 years of age with muscular dystrophies. To be eligible, potential participants must provide written consent in accordance with federal and institutional regulations, demonstrate the ability to follow through on the prescribed treatment plan and study directives, practice a recognised form of contraception, and meet all other criteria outlined by the IRB-approved informed consent document."

Answered by AI

Is this trial a pioneering venture into new medical territory?

"Currently, there are two ongoing clinical trials that involve the drug Losmapimod across 14 cities and 5 nations. In 2019, Fulcrum Therapeutics launched a trial with 14 participants which has since successfully cleared Phase 2 FDA approval stages. Since then 16 additional studies have been conducted."

Answered by AI

Are individuals younger than 55 being admitted to this experiment?

"This medical trial requires patients to be in the age range of 18-65; however, there are 61 trials for minors and 51 for seniors."

Answered by AI

How many participants have been included in this research experiment?

"Unfortunately, this research is not currently open for enrollment. The trial was initially published on February 13th 2020 and last modified on November 3rd 2022. If you desire to join a different experiment, 86 clinical trials are openly enrolling participants with muscular dystrophy and 2 studies are actively recruiting volunteers for Losmapimod treatment."

Answered by AI

What other investigations have been conducted regarding Losmapimod's efficacy?

"Losmapimod's initial studies were conducted in 2019 at Radboud University Medical Center. 16 trials have finished, while two are still open and taking participants; both of these currently being administered through the Columbus Ohio area."

Answered by AI

Recent research and studies

British Journal of Clinical PharmacologyJournal

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Losmapimod Following a Single Intravenous or Oral Dose in Healthy Volunteers

Barbour, April M., Lea Sarov-Blat, Gengqian Cai, Michael J. Fossler, Dennis L. Sprecher, Johann Graggaber, Adam T. McGeoch, Jo Maison, and Joseph Cheriyan. 2013. “Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Losmapimod Following a Single Intravenous or Oral Dose in Healthy Volunteers”. British Journal of Clinical Pharmacology. Wiley. doi:10.1111/bcp.12063.

Human MutationJournal

Common Epigenetic Changes of D4Z4 in Contraction-dependent and Contraction-independent FSHD

de Greef, Jessica C., Richard J.L.F. Lemmers, Baziel G.M. van Engelen, Sabrina Sacconi, Shannon L. Venance, Rune R. Frants, Rabi Tawil, and Silvère M. van der Maarel. 2009. “Common Epigenetic Changes of D4Z4 in Contraction-dependent and Contraction-independent FSHD”. Human Mutation. Wiley. doi:10.1002/humu.21091.

Muscle & NerveJournal

Risk of Functional Impairment in Facioscapulohumeral Muscular Dystrophy

Statland, Jeffrey M., and Rabi Tawil. 2014. “Risk of Functional Impairment in Facioscapulohumeral Muscular Dystrophy”. Muscle & Nerve. Wiley. doi:10.1002/mus.23949.

Human Molecular GeneticsJournal