Open Label Clinical Trial of Anascorp® in Pediatric Patients With Scorpion Sting Envenomation

NCT01599936 | Completed Phase 3

• 1 other identifier: AL-02/06
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Scorpion Sting

Keywords

scorpion sting; envenomation; Anascorp

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)

Anascorp

EXPERIMENTAL

Three vials of Anascorp® will be administered in a total volume of 50 mL, intravenous over not less than 10 minutes or as permitted by IV access

Biological: Anascorp

Interventions

Anascorp BIOLOGICAL

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

Also known as: Antivenin Centruroides (scorpion) equine immune F(ab')2

Anascorp

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 (3)

San Carlos Indian Hospital

San Carlos, Arizona, 85550, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

University Medical Center

Tucson, Arizona, 85724, United States

Location

Related Publications (6)

• 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

• Likes K, Banner W Jr, Chavez M. Centruroides exilicauda envenomation in Arizona. West J Med. 1984 Nov;141(5):634-7.

  PMID: 6516334 BACKGROUND

• Gibly R, Williams M, Walter FG, McNally J, Conroy C, Berg RA. Continuous intravenous midazolam infusion for Centruroides exilicauda scorpion envenomation. Ann Emerg Med. 1999 Nov;34(5):620-5. doi: 10.1016/s0196-0644(99)70164-2.

  PMID: 10533010 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

• LoVecchio F, Welch S, Klemens J, Curry SC, Thomas R. Incidence of immediate and delayed hypersensitivity to Centruroides antivenom. Ann Emerg Med. 1999 Nov;34(5):615-9. doi: 10.1016/s0196-0644(99)70176-9.

  PMID: 10533009 BACKGROUND

• Curry SC, Vance MV, Ryan PJ, Kunkel DB, Northey WT. Envenomation by the scorpion Centruroides sculpturatus. J Toxicol Clin Toxicol. 1983-1984;21(4-5):417-49. doi: 10.3109/15563658308990433.

  PMID: 6381751 BACKGROUND

MeSH Terms

Conditions

Scorpion Stings

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Walter Garcia Ubbelohde, MD

  Instituto Bioclon

  STUDY DIRECTOR

• Leslie V. Boyer, MD

  VIPER Institute, University of Arizona

  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: April 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: June 1, 2007
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

US (3)