Double-Blind, Alacramyn® vs. Placebo in Pediatric Patients

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Scorpion Sting Envenomation

In brief

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 such that the need for transport of most rural patients will be eliminated and will reduce hospitalization time. The working hypotheses are as follows: 1. The investigational antivenom is safe as treatment of scorpion sting envenomation. 2. The investigational antivenom is effective as treatment of scorpion sting envenomation.

Key facts

Study ID

NCT00685230

Run by

Instituto Bioclon S.A. de C.V.

People needed

15

Starts

2004-05-01

Expected to finish

2005-10-01

Last updated by the study team

2011-06-02

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females of 6 months to 18 years of age
• Presenting for emergency treatment within 5 hours with clinically important systemic signs of scorpion sting envenomation.
• Signed written Informed Consent by patient or legal guardian.
• No participation in a clinical drug trial within the last month or concomitantly.

You may not qualify if…

• Allergy to horse serum.
• Use within the past 24 hours of drugs expected to alter immune response: H1 or H2 blockers, corticosteroids.
• Use of any antivenom within the last month or concomitantly.
• Underlying medical conditions that significantly alter immune response: bone marrow suppression congenital or acquired immuno-deficiency state, chemotherapy and chronic corticosteroid use.
• Allergy to midazolam.
• More than 0.3mg/kg of body weight of midazolam administered during the hour prior to study drug infusion.
• Concurrent medical condition involving a baseline neurologic status mimicking envenomation (chorea, tardive dyskinesia, uncontrolled epilepsy).
• Pregnant and nursing women.

Where it is running

• Tucson Medical Center — Tucson, Arizona, United States
• University Medical Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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