Condition category
Nervous System Diseases
Date applied
04/01/2005
Date assigned
10/03/2005
Last edited
17/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Phillip Lee

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AMN002

Study information

Scientific title

Acronym

MCTX in Adrenomyeloneuropathy

Study hypothesis

Not provided at time of registration.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Adrenomyeloneuropathy (AMN)

Intervention

Modified cobratoxin (0.25 mg) administered subcutaneously (sc) twice daily for 6 months versus placebo injections.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

10/03/2000

Overall trial end date

10/03/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

10/03/2000

Recruitment end date

10/03/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

ReceptoPharm Inc. (USA)

Sponsor details

1537 NW 65th Ave
Plantation
33313
United States of America
+1 954 321 8988
receptin@bellsouth.net

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

ReceptoPharm Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12939429

Publication citations

  1. Results

    Mundy HR, Jones SJ, Hobart JC, Hanna MG, Lee PJ, A randomized controlled study of modified cobratoxin in adrenomyeloneuropathy., Neurology, 2003, 61, 4, 528-530.

Additional files

Editorial Notes