Treatment of Pendular Nystagmus in OPT (NCT02466191) | Clinical Trial Compass
CompletedPhase 4
Treatment of Pendular Nystagmus in OPT
France7 participantsStarted 2015-06
Plain-language summary
Pendular nystagmus corresponds to an enduring to and fro eye oscillation without resetting quick phases. The most common causes of acquired pendular nystagmus (APN) are multiple sclerosis (MS) and focal brainstem lesions (oculopalatal tremor, OPT). Based on pathophysiological hypothesis, pharmacological treatments of acquired nystagmus have been thoroughly proposed over different publications of cases, series, reviews or expert opinions. Acquired pendular nystagmus underwent the most rigorous treatment trials, leading to the proposal of gabapentin or memantine as valuable drugs. Whether gabapentin and memantine are effective in APN associated with OPT remains unclear, since none of the previous studies has evaluated the effect of these medications in a group of OPT patients. However, this is an important issue in prospect to a clinical use of these medications. In the current study, the investigators aim is to evaluate the effect of gabapentin and memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on visual acuity and vision-specific health-related quality of life score, in a group of OPT patients
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a diagnosis of oculopalatal tremor (OPT), following a focal brainstem lesion.
* All patients may present a chronic acquired pendular nystagmus due to OPT, observed over a period of 6 months.
* All patients will be informed about the design and purpose of the study, and all will give their informed, written consent to the protocol, which may have been approved by the local ethics committee.
* Age: above 18
* Able to understand the instructions
* Having a health coverage
* Able to sit down for 1 hour
* Stable dosage of previous medications (beginning 3 weeks previously and terminating at the end of the trial duration), except gabapentin or memantine.
* For women: efficient contraception during the experimental time and in the two month following treatment withdrawal.
Exclusion Criteria:
* Ophthalmological
* Other ophthalmological disorder that could impair corrected visual acuity (Maculopathy, Retinopathy…)
* Neurological
* Ongoing seizure
* Severe handicap that does not allow sitting down position for 1 hour
* Suicidal behavior or risk
* Treatment
* Under memantine or gabapentin medication (these medications should have been stopped for at least 1 week for gabapentin and 3 weeks for memantine)
* Under morphine, N-methyl-D-aspartate such as amantadine, ketamine or dextromethorphan
* Steroid medication for a current relapse (beginning 3 weeks previously and terminating at the end of the trial duration
* Known hypersensitivi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial specifically studied pendular nystagmus in oculopalatal tremor and has already been completed, would you be able to share what the results showed about changes in the velocity, amplitude, and frequency of eye movements — and what that might mean for my situation?
2This was a Phase 4 trial, which means the treatment being tested was already approved for some use — can you tell me what medication or intervention was studied, and whether it might already be an option for me outside of a trial?
3Since the trial is now completed and I can no longer enroll, are there any similar active studies looking at treatments for pendular nystagmus or oculopalatal tremor that I might be eligible to discuss?
4The trial measured eye movement using specialized recording equipment — is that kind of detailed eye movement monitoring something that's available here, and would it help us track whether any treatment is actually working for me?
5Given that this trial focused specifically on oculopalatal tremor as the cause of my pendular nystagmus, how confident are you in my diagnosis, and does the cause of my nystagmus affect which treatments are most likely to help?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Velocity, amplitude and frequency of nystagmus using eye movement recording
Timeframe: at Day 17-21
2
Velocity, amplitude and frequency of nystagmus using eye movement recording
Timeframe: at Day 34-42
3
Velocity, amplitude and frequency of nystagmus using eye movement recording
Timeframe: at Day 64-79
4
Velocity, amplitude and frequency of nystagmus using eye movement recording