Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation

NCT01599923 | Completed Phase 3

• 1 other identifier: AL-02/05
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

There is no FDA approved therapy for the treatment of scorpion envenomation in the United States. 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 in the United States, midazolam, and faster-acting thus eliminating the need to transport most rural patients and reducing hospitalization time.

Conditions

Scorpion Sting Envenomation

Keywords

scorpion; envenomation; Alacramyn

Outcome Measures

Primary Outcomes (1)

• Resolution of clinically important systemic signs of scorpion envenomation within four hours after Alacramyn administration.

  Assessments conducted at 1, 2 and 4 hours post administration

Secondary Outcomes (1)

• Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment.

  One hour

Study Arms (1)

Alacramyn

EXPERIMENTAL

Biological: Antivenin Centruroides (scorpion) equine immune F(ab')2

Interventions

Antivenin Centruroides (scorpion) equine immune F(ab')2 BIOLOGICAL

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

Also known as: Alacramyn, Anascorp

Alacramyn

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females 6 months to 18 years of age
• Presenting for emergency care within 5 hours with clinically important signs of scorpion sting envenomation
• Signed written Informed Consent by parent 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
• Use of any antivenom within the last month or concomitantly
• Underlying medical condition that significantly alters immune response
• Concurrent medical condition involving a baseline neurological status mimicking envenomation
• Pregnant and nursing women

Sponsors & Collaborators

• Instituto Bioclon S.A. de C.V.: lead
• University of Arizona: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Children's Hospital of Morelos

Cuernavaca, Morelos, Mexico

Location

Related Publications (2)

• Boyer LV, Theodorou AA, Berg RA, Mallie J; Arizona Envenomation Investigators; Chavez-Mendez A, Garcia-Ubbelohde W, Hardiman S, Alagon A. Antivenom for critically ill children with neurotoxicity from scorpion stings. N Engl J Med. 2009 May 14;360(20):2090-8. doi: 10.1056/NEJMoa0808455.

  PMID: 19439743 BACKGROUND

• Berg RA, Tarantino MD. Envenomation by the scorpion Centruroides exilicauda (C sculpturatus): severe and unusual manifestations. Pediatrics. 1991 Jun;87(6):930-3. No abstract available.

  PMID: 2034501 BACKGROUND

Study Officials

• Walter Garcia Ubbelohde, MD

  Instituto Bioclon

  STUDY DIRECTOR

• Leslie V. Boyer, MD

  VIPER Institute, University of Arizona

  PRINCIPAL INVESTIGATOR

• Neydi Osnaya, MD

  Children's Hospital of Morelos

  PRINCIPAL INVESTIGATOR

• Alejandro Alagon, PhD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: May 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

ME (1)