Treatment for Muscular Dystrophy, Facioscapulohumeral

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Florida, Gainesville, FL
Muscular Dystrophy, Facioscapulohumeral+2 More
Losmapimod - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a study to evaluate the safety and efficacy of losmapimod in treating patients with Facioscapulohumeral Muscular Dystrophy (FSHD) over 48 weeks.

Eligible Conditions

  • Muscular Dystrophy, Facioscapulohumeral
  • Primary Disease Fascioscapulohumeral Dystrophy (FSHD)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Muscular Dystrophy, Facioscapulohumeral

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Screening, Baseline and Weeks 4, 12, 24, 36, 48 and 7 days after the last dose of study drug

Week 4
Treatment-Emergent Adverse Events
Week 4
Neuro-QoL Upper Extremity (UE) Scale
Reachable Workspace (RWS)
Week 48
Muscle Fat Infiltration
Week 4
Patient's Global Impression of Change (PGIC)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Muscular Dystrophy, Facioscapulohumeral

Side Effects for

Losmapimod 7.5 mg BID / 15 mg BID
29%Headache
24%Fatigue
18%Rash
18%Nausea
18%Muscle spasms
18%Vomiting
18%Blood creatinine increased
18%Oropharyngeal pain
18%Dizziness
12%Blood pressure increased
12%Oedema peripheral
12%Upper respiratory tract infection
12%Abdominal pain
12%Dyspepsia
6%Gout
6%Contusion
6%Flatulence
6%Bronchitis
6%Musculoskeletal stiffness
6%Chest discomfort
6%Localised oedema
6%Dysuria
6%Dizziness postural
6%Respiratory tract infection viral
6%Asthma
6%Confusional state
6%Presyncope
6%Ear infection
6%Joint stiffness
6%Gastroenteritis viral
6%Cough
6%Eosinophils urine
6%Breast pain
6%Hyperglycaemia
6%Abdominal pain upper
6%Nasopharyngitis
6%Sinusitis
6%Multiple allergies
6%Diarrhoea
6%Pyrexia
6%Epistaxis
6%Skin papilloma
6%Ear pain
6%Pneumonia
6%Decreased appetite
6%Vitamin D decreased
6%Swelling
6%Cystatin C increased
6%Palpitations
6%Animal bite
6%Hyperhidrosis
6%Anaemia
6%Anxiety
6%Proteinuria
6%Urinary tract infection
6%Blood urea increased
6%Blood albumin increased
6%Nasal congestion
6%Back pain
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT02000440) in the Losmapimod 7.5 mg BID / 15 mg BID ARM group. Side effects include: Headache with 29%, Fatigue with 24%, Rash with 18%, Nausea with 18%, Muscle spasms with 18%.

Trial Design

2 Treatment Groups

Treatment
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

230 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment · Has Placebo Group · Phase 3

Treatment
Drug
Experimental Group · 1 Intervention: Losmapimod · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo oral tablet · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Losmapimod
2019
Completed Phase 2
~230

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening, baseline and weeks 4, 12, 24, 36, 48 and 7 days after the last dose of study drug
Closest Location: University of Florida · Gainesville, FL
Photo of University of Florida  1Photo of University of Florida  2Photo of University of Florida  3
2007First Recorded Clinical Trial
4 TrialsResearching Muscular Dystrophy, Facioscapulohumeral
780 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a genetically confirmed diagnosis of FSHD 1 or FSHD 2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.