NCT00158600View on ClinicalTrials.gov

A Placebo-Controlled Study of Safety and Effectiveness of Myozyme (Alglucosidase Alfa) in Patients With Late-Onset Pompe Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

September 30, 2007

Study Completion Date

September 30, 2007

Conditions
Pompe Disease (Late-onset)Glycogen Storage Disease Type II (GSD-II)Acid Maltase Deficiency DiseaseGlycogenosis 2
Interventions
BIOLOGICAL

alglucosidase alfa

IV infusion of 20mg/kg; qow for 78 weeks.

DRUG

Placebo

Placebo Comparator; qow for 78 weeks.

Trial Locations (8)

10029

Mount Sinai School of Medicine, New York

15213

University of Pittsburgh, Dept. of Neurology, Pittsburgh

20010

Children's National Medical Center, Washington D.C.

63110

Washington University Medical Center, St Louis

75651

Groupe Hospitalier Pitie-Salpetriere, Paris

90211

Tower Hematology Oncology Medical Group, Beverly Hills

3000 CB

Sophia Children's Hospital, Erasmus MC, Rotterdam

3015 GD

Erasmus Medical Centre Rotterdam, Rotterdam

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00158600 - A Placebo-Controlled Study of Safety and Effectiveness of Myozyme (Alglucosidase Alfa) in Patients With Late-Onset Pompe Disease | Biotech Hunter | Biotech Hunter