Who is sponsoring NCT00568802?

NCT00568802 is sponsored by Stanford University.

What condition does NCT00568802 study?

NCT00568802 studies Muscular Atrophy, Spinal.

What drugs are being tested in NCT00568802?

Interventions: Hydroxyurea, Placebo to match hydroxyurea.

What is the status of NCT00568802?

NCT00568802 is currently COMPLETED.

Last reviewed 2019-09-11 · How we verify

A Pilot Therapeutic Trial Using Hydroxyurea in Type II and Type III Spinal Muscular Atrophy Patients

NCT00568802 Phase 1/Phase 2 COMPLETED Results posted

The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in children with Types II and III Spinal Muscular Atrophy; to identify reliable outcome measures for HU treatment in Types II and III SMA; and to detect the clinical efficacy of HU treatment in children with Types II and III SMA.

Details

Lead sponsor	Stanford University
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	27
Start date	2004-01
Completion	2010-03

Conditions

Muscular Atrophy, Spinal

Interventions

Hydroxyurea
Placebo to match hydroxyurea

Primary outcomes

Efficacy: Functional Motor Testing, Including Gross Motor Function Measure (GMFM) and Timed Motor Tests — Up to 6 years, 2 months
Safety: Frequency of Adverse Events/Lab Abnormalities — Up to 6 years, 2 months

Countries

United States