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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: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2006-000032-27-IT
Date of registration: 14/03/2006
Prospective Registration: No
Primary sponsor: ISTITUTO NEUROLOGICO CARLO BESTA
Public title: 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
Scientific title: 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: 19/10/2005
Target sample size: 202
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000032-27
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase: 
Countries of recruitment
Italy
Contacts
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Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Charcot-Marie-Tooth disease type 1A CMT1A
MedDRA version: 6.1 Level: HLGT Classification code 10034606
Intervention(s)

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

Primary Outcome(s)
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.
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.
Primary end point(s): The predefined primary outcome criterion is the effect of AA treatment on the CMTNS Shy .
Secondary Outcome(s)
Secondary ID(s)
GUP05007
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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