Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle (NCT00636519) | Clinical Trial Compass
CompletedPhase 1
Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle
United States36 participantsStarted 2008-02
Plain-language summary
The primary purpose of this study is:
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. 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 per…
What they're measuring
1
Nerve Conduction Study
Timeframe: 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