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Clinical Trials/EUCTR2014-002158-38-FR
EUCTR2014-002158-38-FR
Active, Not Recruiting
N/A

A Study of Respiratory Muscle Strength, including Effort-Independent Measures, in Subjects with Late-Onset Pompe Disease

BioMarin Pharmaceutical Inc0 sites15 target enrollmentJune 25, 2015
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ConditionsPompe diseaseMedDRA version: 18.0Level: LLTClassification code 10036143Term: Pompe's diseaseSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pompe disease
Sponsor
BioMarin Pharmaceutical Inc
Enrollment
15
Status
Active, Not Recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 25, 2015
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Willing and able to provide written informed consent, after the nature of the study has been explained, and prior to any study\-related procedures
  • •Documented diagnosis with late\-onset Pompe disease based on GAA gene mutations and/or endogenous GAA activity \<75% of the lower limit of the normal adult range reported by the testing laboratory, assessed by dried blood spot or whole\-blood assay
  • •At least 18 years of age at study entry
  • •Willing and able to comply with all study procedures
  • •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 15
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •Requires ventilatory support while awake and in the upright position
  • •Concurrent disease, medical condition, or extenuating circumstance that, in the opinion of the investigator, might compromise patient well\-being, study completion, or data collection
  • •Swallowing difficulty precluding balloon catheter placement (eg, esophageal strictures)
  • •Allergy to tools or procedures used for respiratory muscle testing
  • •Implanted ferrous metals (eg, cardiac pacemakers)

Outcomes

Primary Outcomes

Not specified

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