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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00485511
Date of registration:	11/06/2007
Prospective Registration:	No
Primary sponsor:	Kaohsiung Medical University Chung-Ho Memorial Hospital
Public title:	A Trial of Hydroxyurea in Spinal Muscular Atrophy
Scientific title:	A Randomized, Double-Blind, Placebo-Controlled Trial of Hydroxyurea in Spinal Muscular Atrophy
Date of first enrolment:	June 2007
Target sample size:
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00485511
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
Phase:	Phase 2/Phase 3

Countries of recruitment
Taiwan

Contacts

Name:	Yuh Jyh Jong, MD
Address:
Telephone:
Email:
Affiliation:	Vice President, Kaohsiung Medical University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Sixty SMA patients fulfilled the diagnostic criteria of SMA as defined by the
International SMA Consortium (Munsat, 1992), and all had homozygous deletion of SMN1
gene but carried SMN2 gene (Chang, 1995; 1997)

- The subjects shall each have the age older than 4 years.

- The subjects (if age > 20 years old) or their parents (if subject age < 20 years old)
shall agree with the trial and have signed the informed consents.

Exclusion Criteria:

- The subjects shall not have hematological diseases, other severe systemic diseases
and congenital anomalies except for SMA.

- The subjects shall not have severe perinatal asphyxia history.

- The subjects shall not be with respiratory assists.

- The subjects shall have normal hepatic and renal functions in the pre-trial
examination.

- The subjects shall not have received operation with generalized anesthesia in past
half a year.

- The subjects shall not have acceded to other clinical trials in past half a year.

- The subjects shall not get in this trial if they could not complete the course.

Age minimum: 4 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Spinal Muscular Atrophy

Intervention(s)

Drug: Hydroxyurea

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

DOH96-TD-I-111-TM103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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