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Main
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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00271635 |
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Date of registration:
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03/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ascorbic Acid Treatment in CMT1A Trial (AATIC)
AATIC |
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Scientific title:
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Phase 2 Study of Ascorbic Acid Treatment in Charcot-Marie-Tooth Type 1A |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00271635 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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F. Baas, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, Academic Medical Center, University of Amsterdam |
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Name:
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C. Verhamme, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, Academic Medical Center, University of Amsterdam |
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Name:
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I. N van Schaik, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, Academic Medical Center, University of Amsterdam |
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Name:
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R. de Haan, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, Academic Medical Center, University of Amsterdam |
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Name:
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M. de Visser, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, Academic Medical Center, University of Amsterdam |
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Name:
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M. Vermeulen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, Academic Medical Center, University of Amsterdam |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- DNA-proven CMT1A patients
- Age 12-25 years
- CMT 1A patients with symptomatology defined as muscle weakness in at least foot
dorsiflexion
Exclusion Criteria:
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
Age minimum:
12 Years
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hereditary Motor and Sensory Neuropathies
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Charcot-Marie-Tooth Disease
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Intervention(s)
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Drug: Placebo
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Drug: ascorbic acid
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Primary Outcome(s)
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Change in motor nerve conduction velocity of the median nerve after 1 year
[Time Frame: 1 year]
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Secondary Outcome(s)
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Change in AMC Linear Disability Scale score after 1 year
[Time Frame: 1 year]
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Change in minimal F response latency of the median nerve after 1 year
[Time Frame: 1 year]
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Change in overall disability sum score after 1 year
[Time Frame: 1 year]
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Evaluation of serum ascorbic acid concentrations during 1 year
[Time Frame: 1 year]
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Evaluation of side effects during 1 year
[Time Frame: 1 year]
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Change in motor unit number estimation of the abductor pollicis brevis muscle after 1 year
[Time Frame: 1 year]
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Changes in compound muscle action potential amplitude and area after 1 year
[Time Frame: 1 year]
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Changes in handgrip strength, strength of armflexors, foot dorsiflexors, knee extensors and hip flexors after 1 year
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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URL:
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