Treatment of Pendular Nystagmus in OPT

NCT02466191 | Completed Phase 4

• 2 other identifiers: 69HCL14_04382014-005548-17
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pendular Nystagmus; Oculopalatal Tremor

Keywords

nystagmus; pharmacological trial; multiple sclerosis; oscillopsia

Outcome Measures

Primary Outcomes (4)

• Velocity, amplitude and frequency of nystagmus using eye movement recording

  at Day 17-21

• Velocity, amplitude and frequency of nystagmus using eye movement recording

  at Day 34-42

• Velocity, amplitude and frequency of nystagmus using eye movement recording

  at Day 64-79

• Velocity, amplitude and frequency of nystagmus using eye movement recording

  at Day 81-100

Secondary Outcomes (12)

• Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire

  at Day 17-21

• Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire

  at Day 34-42

• Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire

  at Day 64-79

• Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire

  at Day 81-100

• subjective measure of oscillopsia

  at Day 17-21

Study Arms (2)

memantine first

EXPERIMENTAL

Patients will be randomly assigned to start on either memantine or gabapentin. For tolerance reasons, each treatment begins with a progressive increasing dose and stops with a progressive decreasing dose. The duration of the period of last dose (8 to 11 days) will be chosen according to the investigator's availability to organize post-tests.

Drug: Memantine

gabapentin first

EXPERIMENTAL

Patients will be randomly assigned to start on either memantine or gabapentin. For tolerance reasons, each treatment begins with a progressive increasing dose and stops with a progressive decreasing dose. The duration of the period of last dose (8 to 11 days) will be chosen according to the investigator's availability to organize post-tests.

Drug: Gabapentin

Interventions

Memantine DRUG

memantine first

Gabapentin DRUG

gabapentin first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 hypersensitivity to memantine or gabapentin
• General
• Unstable medical state
• Patient with a galactose intolerance, a lapp lactase deficiency or glucose-galactose malabsorption
• Moderate renal failure (creatinine clearance \< 50 mL/min on bioassay dated from less than one month)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69002, France

Location

Related Publications (1)

• Nerrant E, Abouaf L, Pollet-Villard F, Vie AL, Vukusic S, Berthiller J, Colombet B, Vighetto A, Tilikete C. Gabapentin and Memantine for Treatment of Acquired Pendular Nystagmus: Effects on Visual Outcomes. J Neuroophthalmol. 2020 Jun;40(2):198-206. doi: 10.1097/WNO.0000000000000807.

  PMID: 31169568 BACKGROUND

MeSH Terms

Conditions

Nystagmus, Pathologic; Multiple Sclerosis

Interventions

Memantine; Gabapentin

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Caroline TILIKETE, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: June 9, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

FR (1)