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Beta-2 Adrenergic Agonist

Clenbuterol for FSHD (Target FSHD Trial)

Kansas City, KS
Phase 1
Waitlist Available
Research Sponsored by Jeffrey Statland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Genetically confirmed diagnosis of FSHD type 1 or 2, or have a clinical diagnosis of FSHD type 1 with a first degree relative with confirmed mutation
Showing anti-gravity strength on at least one of the tibialis anterior muscles or having an MRI eligible muscle in the leg for needle biopsy
Must not have
Are taking beta-blockers or anabolic agent or potassium wasting diuretics
Are taking any medications or therapies with a contraindication to Clenbuterol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from month 1 to month 6 visit
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find out if Clenbuterol can be used as a treatment for FSHD by testing its safety and how well it is tolerated at three different doses.

See full description
Who is the study for?
This trial is for individuals with Facioscapulohumeral Muscular Dystrophy (FSHD). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of FSHD.Check my eligibility
What is being tested?
The study is testing the safety and tolerability of Clenbuterol at three different doses to see if it can be a treatment option for FSHD. The goal is to find out which dose levels are safe for patients.See study design
What are the potential side effects?
While specific side effects are not listed, Clenbuterol can commonly cause symptoms like jitteriness, increased heart rate, headaches, muscle cramps, and insomnia. Side effects might vary based on the dose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have FSHD type 1 or 2 confirmed by genetic tests or clinical diagnosis.
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I can lift my foot against gravity or have a leg muscle eligible for biopsy.
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I am between 18 and 75 years old.
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I can walk 30 feet on my own without help.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking beta-blockers, anabolic agents, or diuretics that increase potassium loss.
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I am not on medications that can't be taken with Clenbuterol.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from month 1 to month 6 visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and from month 1 to month 6 visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of Clenbuterol-related adverse reactions
Safety ECG
Safety Lab Creatine kinase (CK)
+5 more
Secondary study objectives
Clinical Global Impression of Severity and Change (CGI-S and CGI-C)
FSHD Rasch-built overall disability scale (FSHD-RODS)
FSHD-COM
+6 more

Side effects data

From 2021 Phase 2 trial • 25 Patients • NCT04245709
40%
Jitters/tremors
32%
Cramps/spasms
28%
Insomnia
24%
Stiffness/spasticity
12%
Elevated liver transaminases
8%
Increased work of breathing
8%
Decreased appetite/weight loss
8%
GI upset/nausea
4%
Near-drowning accident
4%
Pulmonary emboli
4%
Elevated thyroxine (T4)
4%
Tachycardia
4%
Constipation
4%
Urinary tract infection
4%
Accelerated disease progression
4%
Headache
4%
Palpitations
4%
Elevated creatine kinase (CK)
4%
Hyperglycemia
4%
Elevated PSA
4%
Tooth removal
4%
Pruritis
4%
Foot pain
4%
Restless legs
4%
Tendinitis
4%
Nasal congestion
4%
Hot flashes
4%
Dizziness/instability
4%
Increased fasciculations
4%
Anxiety
4%
ECG changes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open Label Arm

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Clenbuterol Cohort 3Experimental Treatment1 Intervention
60 mcg taken orally twice daily
Group II: Clenbuterol Cohort 2Experimental Treatment1 Intervention
40 mcg taken orally twice daily
Group III: Clenbuterol Cohort 1Experimental Treatment1 Intervention
20 mcg taken orally twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clenbuterol
2020
Completed Phase 2
~50

Find a Location

Closest Location:University of Kansas Medical Center· Kansas City, KS· 198 miles

Who is running the clinical trial?

Jeffrey StatlandLead Sponsor
1 Previous Clinical Trials
72 Total Patients Enrolled
University of WashingtonOTHER
1,852 Previous Clinical Trials
2,022,592 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
507 Previous Clinical Trials
1,089,756 Total Patients Enrolled
University of RochesterOTHER
882 Previous Clinical Trials
554,661 Total Patients Enrolled
~20 spots leftby Feb 2028
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