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ISRCTN
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ISRCTN48334111
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ClinicalTrials.gov identifier
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Public title
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Randomised, Double-Blind, Placebo Controlled, Cross Over Trial of a Parenteral Modified Cobratoxin in Adrenomyeloneuropathy
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Scientific title
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Acronym
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MCTX in Adrenomyeloneuropathy
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Serial number at source
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AMN002
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Study hypothesis
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Not provided at time of registration.
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Adrenomyeloneuropathy (AMN)
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Participants - inclusion criteria
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1. Male or female age ≥18 years
2. Diagnosis of AMN either biochemically or genetically
3. Have some motor disability that affects their gait
4. Willing and able to provide written informed consent
5. Willing and able to comply with study procedures
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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10/03/2000
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Anticipated end date
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10/03/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration.
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Interventions
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Modified cobratoxin (0.25 mg) administered subcutaneously (sc) twice daily for 6 months versus placebo injections.
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Primary outcome measure(s)
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Not provided at time of registration.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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ReceptoPharm Inc.
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Trial website
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Publications
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2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12939429
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Contact name
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Dr
Phillip
Lee
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Address
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National Hospital for Neurology and Neurosurgery
Queens Square
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City/town
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London
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Zip/Postcode
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WC1N 3BG
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Country
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United Kingdom
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Sponsor
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ReceptoPharm Inc. (USA)
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Address
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1537 NW 65th Ave
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City/town
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Plantation
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Zip/Postcode
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33313
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Country
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United States of America
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Tel
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+1 954 321 8988
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Fax
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+1 954 321 9778
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Email
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receptin@bellsouth.net
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Date applied
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04/01/2005
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Last edited
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17/11/2010
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Date ISRCTN assigned
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10/03/2005
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