Contact information
Type
Scientific
Primary contact
Dr Matthew Craner
ORCID ID
Contact details
Dept of Clinical Neurology
Level 6
West wing
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 1865 222351
matthew.craner@ndcn.ox.ac.uk
Additional identifiers
EudraCT number
2012-004980-39
ClinicalTrials.gov number
NCT01802489
Protocol/serial number
13895
Study information
Scientific title
Amiloride Clinical Trial in Optic Neuritis
Acronym
ACTION
Study hypothesis
The aim of this study is to investigate the neuroprotective efficacy of amiloride in the treatment of multiple sclerosis (MS).
Ethics approval
21/01/2013, ref: 13/SC/0022
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Eye, Neurological; Subtopic: Eye (all Subtopics), Neurological (all Subtopics); Disease: Ophthalmology, Nervous system disorders
Intervention
Amiloride, 10mg per day active group with a double blind randomised placebo group.
Study Entry : Single Randomisation only
Intervention type
Drug
Phase
Phase II
Drug names
Amiloride
Primary outcome measure
Scanning Laser Polarimetry determined retinal fibre layer thickness measured at baseline, 6 and 12 months.
Secondary outcome measures
1. Colour Vision measured at baseline, and 6 months
2. Non-conventional surrogate marker of white matter and grey matter injury and connectivity by 3T MRI measured at baseline, 6 and 12 months
3. Optical Coherence Tomography - determined difference in retinal nerve fibre layer thickness measured at baseline, 6 and 12 months
4. Quality of Life Questionnaires measured at baseline, 6 and 12 months
5. Visual Electrophysiology measured at baseline and 6 months
6. Visual Fuction measured at baselne, 6 and 12 months
Overall trial start date
19/03/2013
Overall trial end date
31/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with a first episode of unilateral ON
2. Participants with an existing diagnosis of relapsing remitting MS and new onset of ON are eligible if they have not had a previous episode of ON
3. A duration of disease of ≤ 10 years
4. An EDSS (Expanded Disability Status Scale) of ≤3
5. No immune modulating treatment other than β-Interferon or Glatiramer Acetate at time of recruitment
6. Able to be randomised within 28 days of onset of visual symptoms
7. Visual acuity of ≤6/9
8. Participant is willing and able to give informed consent for participation in the study and able to comply with study visits
9. Male or Female, aged between 18 55 years.
10. Stable dose of current regular medication for at least 4 weeks prior to study entry
11. Female participants of child bearing potential must be willing to use two effective methods of contraception (barrier methods, hormonal methods or abstinence) during the initial 5 month treatment period of the study and for one month thereafter.
12. Participant has clinically acceptable urea and electrolytes and estimated glomerular filtration rate (eGFR) >60
13. Able and willing to comply with all study requirements.
14. Willing to allow his or her General Practitioner to be notified of participation in the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 46; Description: 23 in the active group and 23 in the placebo comparator group
Participant exclusion criteria
1. Previous diagnosis of ON
2. Any concomitant immune suppressing or immune modulating therapy excluding β-interferon or glatiramer acetate.
3. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
4. Concomitant potassium supplements, angiotensin converting enzyme inhibitors, angiotensin II antagonists, cyclosporine, tacrolimus or lithium
5. Any contra-indication to MRI severe claustrophobia, metal implant, pacemaker, etc.
6. Participant who is terminally ill or is inappropriate for placebo medication
7. Impaired renal function : eGFR ≤60, anuria, acute or chronic renal insufficiency and evidence of diabetic nephropathy
8. Raised serum potassium (K+ >5.5mmol/l)
9. Diabetes
10. Significant concomitant eye disease in either eye that may affect diseased or fellow eye results.
11. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participants ability to participate in the study.
12. Participants who have participated in another research study involving an investigational product in the past 12 weeks.
Recruitment start date
19/03/2013
Recruitment end date
31/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of Clinical Neurology
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Multiple Sclerosis Society (of Great Britain & Northern Ireland); Grant Codes: 952/11
Alternative name(s)
MS Society
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
31/12/2015
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26553836