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Clinical Trials/ISRCTN61074476
ISRCTN61074476
Completed
Not Applicable

Randomised, double blind, placebo-controlled, trial of long-term ascorbic acid treatment in Charcot-Marie-Tooth disease type 1A

niversity College London (UCL) and University College London Hospitals NHS Trust (UCLH) (UK)0 sites50 target enrollmentJune 9, 2008
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ConditionsCharcot-Marie-Tooth disease type 1A (CMT1A)Nervous System DiseasesHereditary and idiopathic neuropathy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Charcot-Marie-Tooth disease type 1A (CMT1A)
Sponsor
niversity College London (UCL) and University College London Hospitals NHS Trust (UCLH) (UK)
Enrollment
50
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 9, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity College London (UCL) and University College London Hospitals NHS Trust (UCLH) (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Clinical diagnosis of CMT1A
  • •2\. Genetic confirmation of CMT1A, based on presence of 17p11\.2 duplication
  • •3\. CMT neuropathy score (CMTNS) between 1 (excluding the electrophysiological component) and 35 (including the electrophysiological component)
  • •4\. Aged 18 \- 70 years, either sex
  • •5\. Ability to accomplish the primary outcome measures
  • •6\. Women of child\-bearing age only if not pregnant or breast feeding
  • •7\. Signed informed consent

Exclusion Criteria

  • •1\. Clinical or echographic diagnosis of nephrolithiasis
  • •2\. Positive history of recurrent renal colic
  • •3\. One or more episodes of renal colic during the six months prior to enrolment
  • •4\. Deficit of glucose\-6P\-dehydrogenase (G6PD) (non\-spherocytic haemolytic anaemia due to G6PD deficiency)
  • •5\. Acquired or hereditary haemochromatosis; thalassemia major; sideroblastic 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 treatment in the three months prior to screening
  • •8\. Other causes of neuropathy (e.g. diabetes, monoclonal gammopathy, cryoglobulinaemia, neoplasms, vitamin B12 deficiency, hepatitis C virus \[HCV]\-related liver disease)
  • •9\. Presence of other neurological disorder (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 the six months prior to screening (or planned before final assessment)

Outcomes

Primary Outcomes

Not specified

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