Application of Miglustat in Patients With Niemann-Pick Type C

NCT ID: NCT01760564

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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To evaluate the changes in cognitive function after miglustat treatment in Niemann-Pick type C patients.

Detailed Description

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Patients with Niemann-Pick C disease will be treated with Miglutat 200mg tid. Neurologic evaluation and safety will be monitored periodically.

Conditions

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Niemann-Pick Disease Type C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Miglustat

miglustat 200mg tid

Group Type EXPERIMENTAL

Miglustat

Intervention Type DRUG

miglustat 200mg tid for adult. For children surface area correction will be made. A lower dose may be used initially to decrease side effect.

Interventions

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Miglustat

miglustat 200mg tid for adult. For children surface area correction will be made. A lower dose may be used initially to decrease side effect.

Intervention Type DRUG

Other Intervention Names

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Zavesca

Eligibility Criteria

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Inclusion Criteria

* Confirm diagnosis of Niemann-Pick C disease
* Symptomatic including motor or mental symptoms

Exclusion Criteria

* Unknown severe diarrhea for more than 7 day
* Allergy to miglustat
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Whu-Liang Hwu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Chien YH, Peng SF, Yang CC, Lee NC, Tsai LK, Huang AC, Su SC, Tseng CC, Hwu WL. Long-term efficacy of miglustat in paediatric patients with Niemann-Pick disease type C. J Inherit Metab Dis. 2013 Jan;36(1):129-37. doi: 10.1007/s10545-012-9479-9. Epub 2012 Apr 5.

Reference Type RESULT
PMID: 22476655 (View on PubMed)

Other Identifiers

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200802043M

Identifier Type: -

Identifier Source: org_study_id

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