NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-163291

Registered date:None

Basic Information

Public title
Scientific titlePhase 1/2 study of NS-065/NCNP-01 in patients with Duchenne muscular dystrophy
Recruitment status
Health condition(s) or Problem(s) studiedDuchenne muscular dystrophy
Study typeINTERVENTIONAL
Phase
Study design
Intervention(s)Intervention name : NS-065/NCNP-01 Dosage And administration of the intervention : intravenous infusion Control intervention name : null
Sample Size16
Date of first enrollment01/4/2016
Completion dateNone
Countries of recruitment

Outcome(s)

Primary OutcomeEfficacy
Secondary OutcomeSafety, Pharmacokinetic profile

Key inclusion & exclusion criteria

Age minimum5
Age maximum17
GenderMale
Include criteria1) Ambulant or non-ambulant patient 2) Able to treat with skipping of exon 53
Exclude criteriaHas participated in other clinical trial that might recover dystrophin protein by the readthrough or the exon-skipping therapy, and/or upregulate the dystrophin-associated proteins such as utrophin.

Related Information

Primary SponsorNIPPON SHINYAKU CO., LTD.
Secondary
Source(s)Refer to the information of contact(s)

Secondary Identifiers

Secondary ID

Contact

public contact
Name NIPPON SHINYAKU CO., LTD. Corporate Communications Dept.
Address kouhou@mb.nippon-shinyaku.co.jp
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Affiliation
scientific contact
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Address
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Ethics Reviews

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Approval Date
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Summary Results

Date of posting of results summaries
Date of the first journal publication of results
URL hyperlink(s) related to results and publications
Baseline Characteristics
Participant flow
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Brief Summary
URL link to protocol file(s) with version and date

IPD sharing statement

Plan to share IPD
Plan description