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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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10 December 2019 |
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Main ID: |
EUCTR2004-002200-14-GB |
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Date of registration:
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18/07/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Randomised Placebo Controlled Trial of a Parenteral Modified Cobratoxin in Adrenomyeloneuropathy - Modified Cobratoxin Therapy in Adrenomyeloneuropathy
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Scientific title:
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Randomised Placebo Controlled Trial of a Parenteral Modified Cobratoxin in Adrenomyeloneuropathy - Modified Cobratoxin Therapy in Adrenomyeloneuropathy |
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Date of first enrolment:
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17/10/2006 |
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Target sample size:
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20 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002200-14 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Male or Female Patients Diagnosed with Adrenomyeloneuropathy.
Disability to cause difficulty with walking.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Asymptomatic Patients, Women of child-bearing potential.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Adrenomyeloneuropathy
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Intervention(s)
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Product Name: modified cobratoxin
Product Code: RPI78M for injection
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Main Objective: This Study Aims to Assess the Safety and Efficacy of Modified Cobratoxin on the Motor Function in Patients with Symptomatic Adrenomyeloneuropathy.
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Secondary Objective: Evoked responses, EDSS, SF-36 Quality of life.
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Primary end point(s): Timed Walk (10M) and Ambulatory Score
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Secondary ID(s)
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483334111
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AMN02
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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