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Continuation Protocol to Protocol BBCO-001

NCT02328482 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-07-17

No results posted yet for this study

Summary

This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent control, parallel group study. Patients completing protocol BBCO-001 will be offered the opportunity to enter into this 12-month randomized withdrawal protocol.

Conditions

  • Muscular Dystrophy, Oculopharyngeal (OPMD)

Interventions

DRUG

Tehalose 30gr

Trehalose 30 g for IV infusion administered every week over an additional 52 weeks

Sponsors & Collaborators

  • Bioblast Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Bernard Brais · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-10-31
Completion
2017-12-31

Countries

  • Canada

Study Locations

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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 NCT02328482 on ClinicalTrials.gov