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Phase II Clinical Trial of Clenbuterol in Adult Patients With Pompe Disease

NCT04094948 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-08-17

No results posted yet for this study

Summary

The goals of this study are to determine safety and efficacy with regard to motor function of oral clenbuterol in combination with ERT in subjects with LOPD

Conditions

  • Pompe Disease (Late-onset)

Interventions

DRUG

Clenbuterol

20 mcg spiropent tablets will be overencapsulated (two 20 mcg tablets per capsule)

DRUG

Placebos

dextrose-filled capsules

Sponsors & Collaborators

Principal Investigators

  • Dwight Koeberl, MD, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-06-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04094948 on ClinicalTrials.gov