Randomised, Double-Blind, Placebo Controlled, Cross Over Trial of a Parenteral Modified Cobratoxin in Adrenomyeloneuropathy

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Phillip Lee
Scientific

National Hospital for Neurology and Neurosurgery
Queens Square
London
WC1N 3BG
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MCTX in Adrenomyeloneuropathy
Study objectives	Not provided at time of registration.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Adrenomyeloneuropathy (AMN)
Intervention	Modified cobratoxin (0.25 mg) administered subcutaneously (sc) twice daily for 6 months versus placebo injections.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	10/03/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Key inclusion criteria	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
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	10/03/2000
Date of final enrolment	10/03/2003

National Hospital for Neurology and Neurosurgery

London
WC1N 3BG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/08/2003		Yes	No