CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 50 enrolled
Drug / intervention
Anascorpbiological
Likely dose
Anascorp 50 mlfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01599936
NCT01599936Phase 3Completed

Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation

Instituto Bioclon S.A. de C.V.·interventional·Posted May 16, 2012·Updated Mar 22, 2016

In Brief

A Phase 3 clinical trial evaluating Anascorp for Scorpion Sting. Completed, enrolled 50 participants across 3 sites.

Detailed Summary

There is no FDA approved therapy for the treatment of scorpion envenomation. Centruroides scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging from trivial to life threatening. Patients stung by Centruroides scorpions develop a clinical syndrome which may require sedation with benzodiazepines and observation for 6 to 28 hours of intensive care monitoring. A safe therapy is necessary to halt the progression of symptoms early in the clinical course while avoiding the clinical deterioration that can occur en route to a tertiary facility. Alacramyn® is anticipated to be safer and more effective than the present standard of care, midazolam, and faster-acting thus eliminating the need to transport most rural patients and reducing hospitalization time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScorpion Sting
CountriesUnited States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 16, 2012
Enrollment StartApr 1, 2004
Primary CompletionOct 1, 2006
Study CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.1 years ago

Interventions

Anascorpbiological

3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.