NCT01830972View on ClinicalTrials.gov

An Open Label Phase 2 Extension Study of Higher Dose Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy

PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

June 4, 2013

Primary Completion Date

February 14, 2017

Study Completion Date

February 14, 2017

Conditions
GNE MyopathyHereditary Inclusion Body Myopathy (HIBM)
Interventions
DRUG

SA-ER 500 mg

oral tablets

DRUG

SA-IR 500 mg

oral capsules

Trial Locations (4)

10016

NYU Medical Center, New York

63110

Washington University School of Medicine, St Louis

90095

UCLA Medical Center, Los Angeles

Unknown

Hadassah University Hospital, Jerusalem

All Listed Sponsors
lead

Ultragenyx Pharmaceutical Inc

INDUSTRY

NCT01830972 - An Open Label Phase 2 Extension Study of Higher Dose Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy | Biotech Hunter | Biotech Hunter