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Extension Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)

NCT03167255 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-12-28

Study results available
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Summary

This is an open-label, extension study of NS-065/NCNP-01 administered intravenously once weekly for an additional 192 weeks to boys with DMD who complete Study NS-065/NCNP-01-201.

Conditions

Interventions

DRUG

NS-065/NCNP-01

Received during weekly intravenous infusions

Sponsors & Collaborators

  • Nippon Shinyaku Co., Ltd.

    collaborator INDUSTRY

  • Cooperative International Neuromuscular Research Group

    collaborator NETWORK

  • Therapeutic Research in Neuromuscular Disorders Solutions

    collaborator INDUSTRY

  • NS Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Paula R. Clemens, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-06
Primary Completion
2021-10-20
Completion
2021-11-15
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03167255 on ClinicalTrials.gov