Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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29 July 2022 |
Main ID: |
NCT04033159 |
Date of registration:
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12/06/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients = 16 Years With Centronuclear Myopathies
Unite-CNM |
Scientific title:
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A Phase 1/2 Trial on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of DYN101 in Patients = 16 Years of Age With Centronuclear Myopathies Caused by Mutations in DNM2 or MTM1. |
Date of first enrolment:
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January 9, 2020 |
Target sample size:
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16 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT04033159 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Belgium
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Denmark
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France
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Germany
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Netherlands
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United Kingdom
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United States
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Contacts
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Name:
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N.C. Voermans, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University Medical Center |
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Name:
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Chris Freitag, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Dynacure |
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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