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Clinical Trials/EUCTR2014-002210-23-DK
EUCTR2014-002210-23-DK
Active, not recruiting
Phase 1

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

Rigshospitalet0 sites15 target enrollmentJune 2, 2014
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ConditionsOculopharyngesl muscle dystrophy, inclusion body myositisMedDRA version: 18.1 Level: LLT Classification code 10019897 Term: Hereditary progressive muscular dystrophy System Organ Class: 100000004850Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsXeomin

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Oculopharyngesl muscle dystrophy, inclusion body myositis
Sponsor
Rigshospitalet
Enrollment
15
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 2, 2014
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •18\-80 years old
  • •IBM or OPMD
  • •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

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

Outcomes

Primary Outcomes

Not specified

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