Miglustat on Gaucher Disease Type IIIB

NCT ID: NCT02520934

Last Updated: 2019-03-29

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

evaluate the combination therapy with Miglustat and enzyme replacement therapy (ERT) on Gaucher disease

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

understand if Miglustat (glucosylceramide synthase inhibitor) could improve neuropathy in patients with Gaucher disease

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gaucher Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case_Miglustat

Besides regular ERT, patients in this group also need to take Miglustat for 24 months.

Group Type EXPERIMENTAL

Miglustat

Intervention Type DRUG

combine miglustat and ERT to see if neurologic manifestations can be improved

ERT

Intervention Type DRUG

enzyme replacement therapy

Control

Patients will be tested for their pupil cycle time.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Miglustat

combine miglustat and ERT to see if neurologic manifestations can be improved

Intervention Type DRUG

ERT

enzyme replacement therapy

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zavesca

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Confirmed diagnosis of Gaucher Disease: blood test shown lack of beta- glucocerebrosidase, and found L444P homozygous on GBA gene.
2. Aged 6 years old or above.
3. Already have regular ERT (30-120 IU/kg/ every 2 weeks) at least a year; dosage and frequency of ERT had not been changed in recent 3 months.


1. Age 6-18 years
2. No significant physical, mental, or psychiatric problems

Exclusion Criteria

1. History of tremor and abnormal extremities perception ( pain, numbness, tingle etc.)
2. Abnormal kidney function.
3. Pregnant or plan to have a baby ( potentially pregnant patient need to be transferred to gynecologist for the test and promise to have proper contraception measures).
4. Allergic to Miglustat.


1\. Children with eye disease (not include myopia, hyperopia, Astigmatism)
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Actelion

INDUSTRY

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yin-Hsiu Chien, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201503076MIPD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Education Program in Myasthenia
NCT04714658 UNKNOWN NA
Iguratimod in Systemic Sclerosis
NCT04515706 UNKNOWN NA