Randomised, Double-Blind, Placebo Controlled, Cross Over Trial of a Parenteral Modified Cobratoxin in Adrenomyeloneuropathy
| ISRCTN | ISRCTN48334111 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48334111 |
| Secondary identifying numbers | AMN002 |
- Submission date
- 04/01/2005
- Registration date
- 10/03/2005
- Last edited
- 17/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Phillip Lee
Scientific
Scientific
National Hospital for Neurology and Neurosurgery
Queens Square
London
WC1N 3BG
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | Not provided at time of registration. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 10/03/2000 |
| Completion date | 10/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration. |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
National Hospital for Neurology and Neurosurgery
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Sponsor information
ReceptoPharm Inc. (USA)
Industry
Industry
1537 NW 65th Ave
Plantation
33313
United States of America
| Phone | +1 954 321 8988 |
|---|---|
| receptin@bellsouth.net |
Funders
Funder type
Industry
ReceptoPharm Inc.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/08/2003 | Yes | No |
