CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
SomatoKine/IPLEXdrug
Likely dose
Cohort 1: 0.5 mg/kg/day SC for 8 weeks, then 1.0 mg/kg/day SC for 16 weeks. Cohort 2: escalating doses (0.5, 1.0, 2.0 mg/kg/day) for consecutive 8-week periods over 24 weeksAI-extracted
Key inclusion· 5
  • ✓Clinical diagnosis of DM-1 confirmed by: clinically evident myotonia, muscle weakness in characteristic distal-predominant distribution, and similar findings in a first-degree relative
  • ✓Age 21 to 60 years inclusive
  • ✓Ability to walk 30 feet without assistance (cane and leg bracing permitted)
  • ✓Distal muscle strength ≤MRC grade 4 (ankle dorsiflexors or deep finger flexors) AND proximal/mid-limb strength ≥MRC grade 4- (knee/elbow/shoulder/hip flexors or extensors)
Key exclusion· 10
  • ✕Congenital DM-1
  • ✕Prior treatment with glucocorticoids, anabolic steroids, testosterone, growth hormone, or IGF-I within 1 year of entry, or any investigational agent within 60 days of entry
  • ✕Any history of malignancy except surgically cured skin cancer or pilomatricoma
  • ✕BMI >30 or weight >100 kg

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00233519
NCT00233519Phase 2Completed
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Effects of SomatoKine (Iplex) (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)

University of Rochester·interventional·Posted Oct 5, 2005·Updated Jun 25, 2012

In Brief

A Phase 2 clinical trial evaluating SomatoKine/IPLEX for Myotonic Dystrophy. Completed, enrolled 17 participants across 1 site.

Detailed Summary

The aim of this study is to investigate the safety and feasibility of daily subcutaneous injections of recombinant IGF1 complexed with IGF binding protein 3 (SomatoKine-INSMED) as a treatment for muscle wasting and weakness in myotonic dystrophy type 1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyotonic Dystrophy
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS), Imsmed Incorporated

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2005
Enrollment StartNov 1, 2005
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.7 years ago

Interventions

SomatoKine/IPLEXdrug

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.