CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
NS-065/NCNP-01 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02740972
NCT02740972Phase 2Completed
CompareCT.gov

A Phase II, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)

NS Pharma, Inc.·interventional·Posted Apr 15, 2016·Updated Dec 7, 2021

In Brief

A Phase 2 clinical trial evaluating NS-065/NCNP-01 and Placebo for Duchenne Muscular Dystrophy. Completed, enrolled 16 participants across 7 sites in 2 countries.

Detailed Summary

The main objective of this study is to evaluate the safety of a high (80mg/kg) and low (40mg/kg) dose of NS-065/NCNP-01 delivered as an intravenous infusion in patients with Duchenne Muscular Dystrophy (DMD) amendable to exon 53 skipping. Additional objectives include tolerability, muscle function and strength, pharmacokinetics and pharmacodynamics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesCanada, United States
CollaboratorsNippon Shinyaku Co., Ltd., Cooperative International Neuromuscular Research Group, Therapeutic Research in Neuromuscular Disorders Solutions

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 15, 2016
Enrollment StartDec 1, 2016
Primary CompletionMar 1, 2018
Study CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.2 years ago

Interventions

NS-065/NCNP-01drug

Placebodrug