NCT00233519View on ClinicalTrials.gov

Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions
Myotonic Dystrophy
Interventions
DRUG

SomatoKine/IPLEX

"Cohort 1: self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.~Cohort 2: consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection."

Trial Locations (1)

14642

University of Rochester Medical Center, Rochester

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

Imsmed Incorporated

INDUSTRY

lead

University of Rochester

OTHER

NCT00233519 - Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1) | Biotech Hunter | Biotech Hunter