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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. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2006-000032-27-IT |
Date of registration:
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14/03/2006 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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MULTICENTRE RANDOMISED DOUBLE BLIND PLACEBO CONTROLLED TRIAL OF LONG-TERM ASCORBIC ACID TREATMENT IN CHARCOT-MARIE-TOOTH DISEASE TYPE 1A CMT-TRIAAL CMT-TRial Italian with Ascorbic Acid Long term - CMT-TRIAAL
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Scientific title:
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MULTICENTRE RANDOMISED DOUBLE BLIND PLACEBO CONTROLLED TRIAL OF LONG-TERM ASCORBIC ACID TREATMENT IN CHARCOT-MARIE-TOOTH DISEASE TYPE 1A CMT-TRIAAL CMT-TRial Italian with Ascorbic Acid Long term - CMT-TRIAAL |
Date of first enrolment:
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19/10/2005 |
Target sample size:
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202 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000032-27 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Clinical diagnosis of CMT1A; 2. Genetic confirmation of CMT1A diagnosis, based on presence of the 17p11.2 duplication; 3. CMT Neuropathy Score CMTNS between 1 excluding the electrophysiological component and 35 including the electrophysiological component Shy ; 4. Age 18-70 years; 5. Ability to accomplish the primary outcome measures; 6. Women of child-bearing age only if they declare not to be pregnant or breast feeding at the inclusion into the study and to avoid becoming pregnant during the study; 7. Signed informed patient consent. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Clinical or echographic diagnosis of nephrolithiasis; 2. Positive history of recurrent renal colics; 3. One or more episodes of renal colic during the 6 months prior to the enrolment; 4. Deficit of Glucose-6P-Dehydrogenase G6PD ; 5. Acquired or hereditary haemochromatosis; thalassemia major; syderoblastic anaemia; 6. Treatment with ramified chain amino-acids or other drugs considered as potential therapeutic agents for CMT1A during the three months prior to screening; 7. AA consumption in the three months prior to screening; 8. Other causes of neuropathy e.g. diabetes, monoclonal gammopathy, neoplasms, B12 deficiency, HCV-related liver disease ; 9. Presence of other neurological disorders such as multiple sclerosis, cerebrovascular diseases, movement disorders , or major comorbidities e.g., definite cognitive impairment, psychiatric disease, heart or lung failure, orthopaedic or rheumatological disorders ; 10. Limb surgery during in the six months prior to screening or planned before final assessment .
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Charcot-Marie-Tooth disease type 1A CMT1A MedDRA version: 6.1
Level: HLGT
Classification code 10034606
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Intervention(s)
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Trade Name: CEBION 500MG 20CPR MAST.ARAN Pharmaceutical Form: Chewable tablet INN or Proposed INN: ACIDO ASCORBICO DC.IT CAS Number: 50-81-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- INN or Proposed INN: SODIO ASCORBATO DC.IT CAS Number: 134-03-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Chewable tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: To develop and validate an evaluation protocol that is suitable for future trials in CMT disease. To establish a network of centres with long-lasting experience in CMT in which such a protocol can be homogeneously applied.
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Main Objective: To assess the efficacy and safety of chronic treatment with ascorbic acid versus placebo in CMT1A through a multicentre randomised double-blind controlled trial.
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Primary end point(s): The predefined primary outcome criterion is the effect of AA treatment on the CMTNS Shy .
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Source(s) of Monetary Support
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Results
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Results available:
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