Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005548-17 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug |
| ||
| Gabapentin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Ophthalmological
Neurological
Suicidal behavior or risk
Treatment
General
Pregnancy (on questioning)
Tutelage or any legal protection measure
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Caroline TILIKETE, Pr | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Lyon | 69002 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31169568 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009759 | Nystagmus, Pathologic |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008559 | Memantine |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| subjective measure of oscillopsia | at Day 34-42 |
| subjective measure of oscillopsia | at Day 64-79 |
| subjective measure of oscillopsia | at Day 81-100 |
| far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location. | at Day 17-21 |
| far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location. | at Day 34-42 |
| far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location. | at Day 64-79 |
| far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location. | at Day 81-100 |
| D020278 |
| Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |