What side effects are associated with this type of intervention?

The most common treatments for Facioscapulohumeral Muscular Dystrophy (FSHD), including those similar to Losmapimod (a selective p38 MAPK inhibitor), often involve managing symptoms and slowing disease progression. Known side effects of such treatments can include gastrointestinal issues, fatigue, infections, and cytopenias. In the specific context of Losmapimod, long-term safety and tolerability are being evaluated, but typical side effects observed in similar treatments may include mild to moderate adverse events such as gastrointestinal reactions and fatigue.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of Facioscapulohumeral Muscular Dystrophy (FSHD) in the provided context. However, Losmapimod, a selective p38 MAPK inhibitor, is currently being studied for its efficacy and safety in treating FSHD. This suggests that research is ongoing to find effective treatments for this condition.

What other types of research exist?

As of now, there are no specific alternatives to Losmapimod mentioned in the provided context for treating Facioscapulohumeral Muscular Dystrophy (FSHD). Patients should consult with their healthcare provider to explore ongoing clinical trials and emerging therapies that may be suitable for their condition.

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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

Must not have

For subjects who are on drug(s) or supplements that may affect muscle function, as determined by the treating physician, or that are included in the list of drugs presented in the protocol, subjects must be on a stable dose of that drug(s) or supplement for at least 3 months prior to the first dose of study drug and remain on that stable dose for the duration of the study. Changes to the dose or treatment discontinuation during the study can only be done for strict medical reasons by the treating physician with clear documentation and notification to the sponsor

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

No Placebo-Only Group

Summary

This trial is testing if the medication Losmapimod is safe for long-term use in patients with FSHD1. Patients will take the medication twice daily and visit the clinic regularly to check for any side effects. Losmapimod has been previously tested in other conditions but did not show significant efficacy.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I've been on a stable dose of medication or supplements that could affect muscle function for at least 3 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and Tolerability of Losmapimod

Secondary study objectives

Lean Muscle Volume

Muscle Fat Fraction

Muscle Fat Infiltration

+1 more

Other study objectives

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%

Vomiting

18%

Muscle spasms

18%

Rash

18%

Oropharyngeal pain

18%

Blood creatinine increased

18%

Nausea

18%

Dizziness

12%

Oedema peripheral

12%

Abdominal pain

12%

Dyspepsia

12%

Blood pressure increased

12%

Upper respiratory tract infection

Bronchitis

Dizziness postural

Sinusitis

Nasal congestion

Anaemia

Skin papilloma

Breast pain

Vitamin D decreased

Back pain

Decreased appetite

Hyperglycaemia

Animal bite

Contusion

Confusional state

Proteinuria

Joint stiffness

Hyperhidrosis

Musculoskeletal stiffness

Gout

Dysuria

Multiple allergies

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Losmapimod, a selective p38 MAPK inhibitor, works by targeting the p38 MAPK pathway, which is crucial in inflammatory responses and cellular stress signaling. By inhibiting this pathway, Losmapimod aims to reduce inflammation and muscle damage, key contributors to the progression of Facioscapulohumeral Muscular Dystrophy (FSHD). This mechanism is significant for FSHD patients as it may slow disease progression and improve muscle function, ultimately enhancing their quality of life.