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MAP Kinase Inhibitor

Losmapimod for Facioscapulohumeral Muscular Dystrophy

Phase 3

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

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

Genetically confirmed diagnosis of FSHD 1 or FSHD 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 192

Awards & highlights

Study Summary

This trial will test whether losmapimod is safe and effective in treating patients with FSHD over 48 weeks.

Who is the study for?

Adults aged 18-65 with genetically confirmed Facioscapulohumeral Muscular Dystrophy (FSHD1 or FSHD2) and a specific range of muscle strength loss can join. They must not be wheelchair-dependent, have no MRI contraindications, and cannot be on certain drugs affecting muscle function unless stable for 3 months.Check my eligibility

What is being tested?

The trial is testing Losmapimod's effectiveness in treating FSHD by comparing it to a placebo. Participants will take the drug or placebo twice daily. After this phase, they may continue in an extension study to assess long-term effects.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but could include reactions related to liver or kidney health due to exclusion criteria regarding these organs' conditions.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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I have a genetic diagnosis of FSHD type 1 or 2.

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I can walk without needing a wheelchair or walker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 192

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 192

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 192 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part A: Change from Baseline in total Relative surface area (RSA) Quadrants 1 to 5 (Q1-Q5) with 500 grams (g) wrist weight averaged over both arms as assessed by Reachable workspace (RWS) at Week 48

Part B: Number of participants reporting Adverse events (AEs)

Part B: Number of participants with clinically significant changes in clinical laboratory parameters, Electrocardiogram (ECG), vital signs and physical examinations

Secondary outcome measures

Part A: Change from Baseline in Quality of Life in Neurologic Disorders upper extremity (Neuro-QoL UE) Scale at Week 48

Part A: Change from Baseline in Whole body (WB) longitudinal composite Muscle Fat Infiltration (MFI) of B muscles at Week 48

Part A: Change from Baseline in average shoulder abductor strength by hand-held quantitative dynamometry at Week 48

+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

Hyperglycaemia

Proteinuria

Hyperhidrosis

Vitamin D decreased

Dysuria

Confusional state

Anaemia

Skin papilloma

Back pain

Nasal congestion

Decreased appetite

Animal bite

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

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: Open-label extensionExperimental Treatment1 Intervention

Participants will receive losmapimod, upon completion of all assessments for Part A.

Group II: Part A: Placebo-controlled treatment period: LosmapimodExperimental Treatment1 Intervention

Participants will be randomized to receive losmapimod.

Group III: Part A: Placebo-controlled treatment period: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Losmapimod

2019

Completed Phase 2

~230

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fulcrum TherapeuticsLead Sponsor

7 Previous Clinical Trials

419 Total Patients Enrolled

Marie-Helene Jouvin, MDStudy DirectorFulcrum Therapeutics

3 Previous Clinical Trials

108 Total Patients Enrolled

Santiago Arroyo, MD, PhDStudy DirectorFulcrum Therapeutics

2 Previous Clinical Trials

90 Total Patients Enrolled

Media Library

Losmapimod (MAP Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05397470 — Phase 3

Facioscapulohumeral Muscular Dystrophy Research Study Groups: Part A: Placebo-controlled treatment period: Losmapimod, Part A: Placebo-controlled treatment period: Placebo, Part B: Open-label extension

Facioscapulohumeral Muscular Dystrophy Clinical Trial 2023: Losmapimod Highlights & Side Effects. Trial Name: NCT05397470 — Phase 3

Losmapimod (MAP Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05397470 — Phase 3

Frequently Asked Questions

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

How many places are administering this clinical trial?

"20 different hospitals are participating in this clinical trial, including Ottawa Hospital Research Institute in Ottawa, Ontario, University of Texas Southwestern Medical Center in Dallas, Texas, and University of Colorado Anschutz Medical Campus in Aurora, Colorado."

Answered by AI

Are you looking for more test subjects at the moment?

"The trial, which was initially posted on June 16th, 2020, is still recruiting patients as of October 13th, 2020."

Answered by AI

Has Losmapimod undergone the FDA's approval process?

"Losmapimod has undergone multiple rounds of testing with positive results, meaning it scores a 3 on our safety scale."

Answered by AI

If I'm younger than 45, can I still join this experiment?

"This clinical trial is open to patients aged 18 to 65. There are 62 studies available for patients that are minors and 50 for patients that are elderly."

Answered by AI

How many individuals are researchers observing in this clinical trial?

"The sponsor, Fulcrum Therapeutics, needs to recruit 230 individuals who meet the study's inclusion criteria in order to begin. The trial will be conducted in multiple locations, including the Ottawa Hospital Research Institute in Ottawa, Ontario and University of Texas Southwestern Medical Center in Dallas, Texas."

Answered by AI