Condition category
Nervous System Diseases
Date applied
22/11/2005
Date assigned
22/11/2005
Last edited
18/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr C. Verhamme

ORCID ID

Contact details

Academic Medical Center
Department of Neurology
P.O. Box 22660
Amsterdam
-
Netherlands
+31 (0)20 5663856
c.verhamme@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

AATIC

Study hypothesis

Ascorbic acid has been shown to have a favorable influence on myelination in in vitro studies and in a mouse model for CMT1A. We will study the efficacy and safety of ascorbic acid treatment in young patients with CMT1A.

Ethics approval

Received from local medical ethics committee

Study design

Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Charcot-Marie-Tooth Disease Type 1A (CMT1A), Hereditary Motor and Sensory Neuropathies (HMSN Ia)

Intervention

Ascorbic acid 1000 mg (4 capsules of 250 mg) twice daily for one year or placebo in 4 capsules twice daily for one year

Intervention type

Drug

Phase

Not Specified

Drug names

Ascorbic acid

Primary outcome measures

Change in motor nerve conduction velocity of the median nerve after 1 year

Secondary outcome measures

1. Change in minimal F response latency of the median nerve after 1 year
2. Changes in compound muscle action potential amplitude and area after 1 year
3. Change in motor unit number estimation of the abductor pollicis brevis muscle after 1 year
4. Changes in handgrip strength, strength of armflexors, foot dorsiflexors, knee extensors and hip flexors after 1 year
5. Change in overall disability sum score after 1 year
6. Change in AMC Linear Disability Scale score after 1 year
7. Evaluation of serum ascorbic acid concentrations during 1 year
8. Evaluation of side effects during 1 year

Overall trial start date

01/11/2005

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. DNA-proven CMT1A patients
2. Age 12-25 years
3. CMT1A patients with symptomatology defined as muscle weakness in at least foot dorsiflexion

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Due to possible influence on severity of the neuropathy:
1.1. 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
1.2. Medication that may cause a neuropathy
1.3. Chronic alcohol abuse
2. Due to study medication (ascorbic acid):
2.1. Regular use of vitamin C
2.2. Clinical or echographic signs of nephrolithiasis
2.3. Reduced glomerular filtration rate
2.4. Iron overload
2.5. No regular dental control at the dentist
2.6. Pregnancy or active pregnancy wish for women
3. Due to study design and primary outcome:
3.1. Not signing the informed consent
3.2. Psychiatric co-morbidity which may influence compliance
3.3. Not being comfortable during nerve conduction studies of the median nerve
3.4. A too small Compound Muscle Action Potential (CMAP) amplitude of the abductor pollicis brevis muscle for a proper determination of the nerve conduction velocity of the median nerve

Recruitment start date

01/11/2005

Recruitment end date

01/11/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
-
Netherlands

Sponsor information

Organisation

Academic Medical Centre, Department of Neurology (Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

http://www.amc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre, Department of Neurology (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19909499

Publication citations

  1. Results

    Verhamme C, de Haan RJ, Vermeulen M, Baas F, de Visser M, van Schaik IN, Oral high dose ascorbic acid treatment for one year in young CMT1A patients: a randomised, double-blind, placebo-controlled phase II trial., BMC Med, 2009, 7, 70, doi: 10.1186/1741-7015-7-70.

Additional files

Editorial Notes