Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle

NCT00636519 | Completed Phase 1

• 1 other identifier: BT002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

The primary purpose of this study is:

1. 1.To evaluate the model determined by the ability of botulism antitoxin (bivalent, Aventis) to neutralize Botulinum toxin in the Extensor Digitorum Brevis model of muscle paralysis in Stage A.
2. 2.To assess the ability of botulism antitoxin (heptavalent, Cangene) to neutralize Botulinum toxin in the Extensor Digitorum Brevis model of muscle paralysis in Stage B.

Conditions

Healthy Volunteers

Keywords

Botulism Antitoxin,Heptavalent,Bivalent,EDB Muscle,Paralysis

Outcome Measures

Primary Outcomes (1)

• Nerve Conduction Study

  Screening, Baseline (Day 0, -3 hrs), Day 1 (-1 hr), Day 3, Day 4, Day 7, Day 14, Day 21, Day 28 or Early Withdrawal

Secondary Outcomes (8)

• Hematology

  Screening, Baseline (Day 0, -3 hr), Day 7, Day 14, Day 21, Day 28 or Early Withdrawal

• Blood Chemistry

  Screening, Baseline (Day 0, -3 hr), Day 7, Day 14, Day 21, Day 28 or Early Withdrawal

• Urinalysis

  Screening, Baseline (Day 0, -3 hr), Day 7, Day 14, Day 21, Day 28 or Early Withdrawal

• Serum anti-Botulism Antitoxin Reactivity

  Baseline, Day 28 or Early Withdrawal

• Adverse Events

  Day 0, Day 1( -1 hr), Day 1, Day 3, Day 4, Day 7, Day 14, Day 21, and Day 28 or Early Withdrawal

Study Arms (2)

Stage A

EXPERIMENTAL

Botulism Antitoxin Bivalent (Equine) Types A and B Vs. Placebo

Biological: Botulism Antitoxin Bivalent (Equine) Types A and B

Stage B

EXPERIMENTAL

Botulism Antitoxin Heptavalent (Equine) Types A-G Vs. Placebo

Biological: Botulism Antitoxin Heptavalent (Equine) Types A-G

Interventions

Botulism Antitoxin Bivalent (Equine) Types A and B BIOLOGICAL

One vial of Botulism Antitoxin Bivalent(Equine) Types A and B (1:10 in saline) or an Equivalent Volume of Placebo on Day 0 in Stage A

Stage A

Botulism Antitoxin Heptavalent (Equine) Types A-G BIOLOGICAL

One vial of Heptavalent Botulism Antitoxin (1:10 in saline) or an Equivalent Volume of Placebo on Day 0 in Stage B

Stage B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• Age 18 - 55 years
• Body-mass index 19-30
• Normal and healthy as determined by medical history, physical examination, ECG, NCS, vital signs and tests of liver, kidney and hematological functions
• Adequate form of contraception for female subjects
• For women with child-bearing potential-using hormonal contraception (oral, injectable or implant) continuously for 3 months prior to the start of the study and willing to continue to use hormonal contraception throughout the entire study. IUD inserted or use of condoms for at least 2 months prior to dosing
• Other forms of contraception may be considered as adequate at physician's discretion
• Surgically-sterilized female subjects
• For female subjects who are postmenopausal, an FSH ≥ than 40 mIU/mL must be obtained. If the FSH is \< 40 mIU/mL the subject must agree to use an acceptable form of contraception (see above for acceptable forms of contraception)
• Signed written Informed Consent

You may not qualify if:

• Previously injected with BOTOX®, BOTOX® COSMETIC or MYOBLOC®
• Any known or documented Botulinum infection/intoxication
• Any known or documented allergies to horses (e.g. rash, wheezing, rhinitis etc. after exposure to horses)
• Any known or documented allergies to horse serum (observation of adverse events after treatment with any kind of product containing horse serum)
• Any moderate or severe food allergies, seasonal allergies or hay fever requiring treatment with peroral or parenteral immunosuppressive drug
• Any known or documented hypersensitivity to blood products derived from a human or equine source
• Any known or documented hypersensitivity to albumin
• Positive result for Botulism Antitoxin skin sensitivity testing
• Any known or documented allergy to rubber, latex or plastic
• Known acute or chronic moderate or severe asthma requiring treatment with peroral and / or parenteral immunosuppressive drugs
• Previously diagnosed or currently suspected Multiple Sclerosis or other neuromuscular degenerative disorder
• Previously diagnosed or currently suspected motor neuron disease
• Previously or currently diagnosed peripheral neuropathy of lower extremities' nerves
• Current infection of the skin / skin problems at the injection site (foot)
• Scar tissue or tattoo of the skin over the extensor digitorum brevis muscles.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Department of Health and Human Services: collaborator

Study Sites (2)

Dr. Gordon Peterson

Loma Linda, California, 92354, United States

Location

R. Richard Sloop, M. D.

Yakima, Washington, 98902, United States

Location

Related Publications (3)

• Benedetto AV. The cosmetic uses of Botulinum toxin type A. Int J Dermatol. 1999 Sep;38(9):641-55. doi: 10.1046/j.1365-4362.1999.00722.x. No abstract available.

  PMID: 10517680 BACKGROUND

• Carruthers A, Carruthers J. Cosmetic uses of botulinum A exotoxin. Adv Dermatol. 1997;12:325-47; discussion 348. No abstract available.

  PMID: 8973746 BACKGROUND

• Tacket CO, Shandera WX, Mann JM, Hargrett NT, Blake PA. Equine antitoxin use and other factors that predict outcome in type A foodborne botulism. Am J Med. 1984 May;76(5):794-8. doi: 10.1016/0002-9343(84)90988-4.

  PMID: 6720725 BACKGROUND

Study Officials

• Richard Sloop, M. D.

  R. Richard Sloop, M. D.

  PRINCIPAL INVESTIGATOR

• Gordon Peterson, Dr.

  Faculty Physicains & Surgeons of Loma Linda University School of Medicine, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 14, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

US (2)