Amiloride Clinical Trial in Optic Neuritis
| ISRCTN | ISRCTN99153976 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99153976 |
| EudraCT/CTIS number | 2012-004980-39 |
| ClinicalTrials.gov number | NCT01802489 |
| Secondary identifying numbers | 13895 |
- Submission date
- 03/05/2013
- Registration date
- 03/05/2013
- Last edited
- 06/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Matthew Craner
Scientific
Scientific
Dept of Clinical Neurology
Level 6
West wing
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 1865 222351 |
|---|---|
| matthew.craner@ndcn.ox.ac.uk |
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Amiloride Clinical Trial in Optic Neuritis |
| Study acronym | ACTION |
| Study objectives | The aim of this study is to investigate the neuroprotective efficacy of amiloride in the treatment of multiple sclerosis (MS). |
| Ethics approval(s) | 21/01/2013, ref: 13/SC/0022 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 19/03/2013 |
| Completion date | 31/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 46; Description: 23 in the active group and 23 in the placebo comparator group |
| Key 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. |
| Key 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. |
| Date of first enrolment | 19/03/2013 |
| Date of final enrolment | 31/03/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dept of Clinical Neurology
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Website | http://www.ox.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Multiple Sclerosis Society (of Great Britain & Northern Ireland); Grant Codes: 952/11
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/11/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
05/01/2017: Publication reference added.
