Condition category
Nervous System Diseases
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
29/01/2010
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 M Engelen

ORCID ID

Contact details

Academic Medical Centre (AMC)
Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

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

http://www.amc.nl/

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

  1. 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.

Additional files

Editorial Notes