Acute optic neuritis Nervous System Diseases
Conditions
Interventions
Treatment arm: A single oral 60 mg dose of Nimodipine tablets will be given on one occasion. Participants will receive ophthalmological and safety assessments over approximately 3 hours after dosing a
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Treatment group: 1. Participants aged 18-60 years 2. A history of typical, demyelinating acute monocular (unilateral) optic neuritis 3. Symptom onset (pain and/or visual dysfunction) for less than 2 weeks before study inclusion 4. Baseline visually evoked potentials confirm optic nerve conduction delays, while baseline pattern on electroretinography is not suggestive of retinal disease as an alternative diagnosis 5. Participants must be willing and able to provide written informed consent 6. Female participants of childbearing potential must have a negative urinary pregnancy test on the date of inclusion and agree to use a highly effective method of contraception from the time consent is signed until 48 hours after treatment administration (due to a lack of safety data on the use of nimodipine in pregnant and breastfeeding women; and to allow for medication washout post treatment discontinuation). Highly effective methods of contraception acceptable for this trial are barrier mechanisms and hormonal mechanisms with 100% compliance for the duration of treatment, these include: 6.1. Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation 6.2. Oral 6.3. Intravaginal 6.4. Transdermal 6.5. Progesterone-only hormonal contraception associated with inhibition of ovulation 6.6. Oral 6.7. Injectable 6.8. Implantable 6.9 Intrauterine device 6.10. Intrauterine hormone-releasing system 6.11. Bilateral tubal occlusion 6.12. Vasectomised partner (when this is the sole partner of the WOCBP participant and the vasectomised partner has received a medical assessment of the surgical success) 6.13. Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments, and the reliability of sexual abstinence is in line with the preferred and usual lifestyle of the subject) NOTE: For the purpose of this document, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Control Group: 1. Age 18-60 years (inclusive). 2. No history of ophthalmological or neurological disease 3. Baseline visual evoked potentials confirm normal optic nerve conduction studies 4. Baseline pattern electroretinography does not suggest retinal disease as an alternative or concomitant diagnosis. 5. Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Treatment Group: 1. Participants with a prior diagnosis of ophthalmic or retinal disease (i.e. diabetic retinopathy, macular degeneration, glaucoma, severe myopia (>5D)). 2. Participants with a history of significant cardiac disease (e.g., cardiac conduction block or ischaemic heart disease) 3. Participants who are pregnant at the time of study recruitment or currently breastfeeding 4. Participants with abnormal vital signs (pulse >120bpm or 160mmHg or 100mmHg or 5D)) 4. History of photo-sensitive epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events will be measured based on various ophthalmological and safety assessments, as well as verbal feedback from the participant, taken from screening until discharge from the study (24 hours after dosing) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Description of changes in (pattern) visual evoked potential (PVEP/VEPs) measurements taken at 60, 90, 150 and 180 minutes after dosing 2. Changes in (pattern) electroretinography (PERG/ERG) measurements taken at 180 minutes after dosing 3. Description of changes in visual acuity (high- and low-contrast with LogMAR and Sloan charts respectively) at 90 and 180 minutes after dosing 4. Description of changes in relative afferent pupillary deficits attenuated (RAPD) pupillary light responses in optic neuritis) using monocular pupillometry (NeurOptics) measured at 90 and 180 minutes after dosing 5. Description of changes in retinal oxygenation (using OCT) at 180 minutes after dosing | — |
Countries
England, United Kingdom
Contacts
Public ContactOlivia Fox
Outcome results
None listed