Status:
COMPLETED
Ascorbic Acid Treatment in CMT1A Trial (AATIC)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Charcot-Marie-Tooth Disease
Hereditary Motor and Sensory Neuropathies
Eligibility:
All Genders
12-25 years
Phase:
PHASE2
Brief Summary
Charcot-Marie-Tooth type IA (CMT1A) is the most prevalent hereditary peripheral neuropathy. Demyelination of peripheral nerves is the hallmark of CMT1A. Ascorbic acid has been shown to have a favorabl...
Detailed Description
Charcot-Marie-Tooth type 1A (CMT1A), or hereditary motor and sensory neuropathy type Ia (HMSN Ia), is an autosomal dominant disease, most often caused by a 1.5 Mb duplication of chromosome 17, giving ...
Eligibility Criteria
Inclusion
- DNA-proven CMT1A patients
- Age 12-25 years
- CMT 1A patients with symptomatology defined as muscle weakness in at least foot dorsiflexion
Exclusion
- Due to possible influence on severity of the neuropathy:
- Known other disease that may cause a neuropathy, that may decrease mobility, or that may lead to severe disability or death in a short time
- Medication that may cause a neuropathy
- Chronic alcohol abuse
- Due to study medication (ascorbic acid):
- Regular use of vitamin C
- Clinical or echographic signs of nephrolithiasis
- Reduced glomerular filtration rate
- Iron overload
- No regular dental control at the dentist
- Pregnancy or active pregnancy wish for women
- Due to study design and primary outcome:
- Not signing the informed consent
- Psychiatric co-morbidity which may influence compliance
- Not being comfortable during nerve conduction studies of the median nerve
- A too small CMAP amplitude of the abductor pollicis brevis muscle for a proper determination of the nerve conduction velocity of the median nerve
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00271635
Start Date
January 1 2006
End Date
July 1 2007
Last Update
July 4 2008
Active Locations (1)
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1
Department of Neurology Academic Medical Center University of Amsterdam
Amsterdam, P.O.Box 22660, Netherlands, 1100 DD