Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC05/175; NTR682
Study information
Scientific title
Acronym
LOVA
Study hypothesis
Cholesterol lowering by low fat diet and lovastatin will also reduce very long chain fatty acids in patients with X-linked adrenoleukodystrophy (X-ALD).
Ethics approval
Received from the local medical ethics committee
Study design
Randomised double-blind placebo controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
X-linked adrenoleukodystrophy (X-ALD)
Intervention
1. All patients participating in the trial will comply to a diet (American Heart Association level 1)
2. All patients will receive six months of placebo and six months of lovastatin 40 mg daily in random order (double blind, crossover design)
Intervention type
Drug
Phase
Not Specified
Drug names
Lovastatin
Primary outcome measures
Very long chain fatty acid levels (in plasma and erythrocytes).
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/08/2006
Overall trial end date
01/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male patients with X-ALD (confirmed by biochemical analysis or mutation analysis of the ABCD1 gene)
2. 18 years or older
3. Able to give informed consent and visit the hospital
4. No contraindications for use of trial medication
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
20
Participant exclusion criteria
1. Use of another cholesterol lowering drug
2. Liver disease or creatine kinase (CK) more than three times baseline level
3. Use of very long chain fatty acid lowering therapy (e.g. Lorenzo's oil) in the eight weeks preceding the study
Recruitment start date
01/08/2006
Recruitment end date
01/08/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
European Leukodystrophy Foundation (ELA)
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20089986
Publication citations
-
Results
Engelen M, Ofman R, Dijkgraaf MG, Hijzen M, van der Wardt LA, van Geel BM, de Visser M, Wanders RJ, Poll-The BT, Kemp S, Lovastatin in X-linked adrenoleukodystrophy., N. Engl. J. Med., 2010, 362, 3, 276-277, doi: 10.1056/NEJMc0907735.