Can local botulinum toxin improve swallowing difficulties in persons with msucle disease?

Can local intramuscular botulinum toxin improve dysphagia in patients with myopathic dysphagia and constriction of the cricoid muscle?

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002210-23-DK

Enrollment

Registered

2014-06-02

Start date

2014-10-14

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oculopharyngesl muscle dystrophy, inclusion body myositis MedDRA version: 18.1 Level: LLT Classification code 10019897 Term: Hereditary progressive muscular dystrophy System Organ Class: 100000004850

Interventions

Trade Name: Xeomin Product Name: Xeomin Pharmaceutical Form: Concentrate and solvent for solution for injection CAS Number: 93384-43-1 O

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 18-80 years old • IBM or OPMD • Dysphagia • Signed informed consent • Stable dosing of immunemodulation •No other important reason for dysphagia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Involvement in other trial last 30 days Medication or disease incompatible with botox Botox allergy Botox treatment within 6 mth Pregnant or lactating

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if local intramuscular botulinum toxin can alleviate myopahtic dysphagia;Secondary Objective: None;Primary end point(s): Improvement in dysphagia;Timepoint(s) of evaluation of this end point: 4 and 12 weeks	—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: 0	—

Countries

Denmark

Contacts

Public ContactNeurology 2081

Rigshospitalet

nanna.witting@regionh.dk4535459674

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026