PENDULAR NYSTAGMUS IN PATIENTS WITH MULTIPLE SCLEROSIS OR OCULOPALATAL TREMOR MedDRA version: 18.0 Level: PT Classification code 10029864 Term: Nystagmus System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: NEURONTIN
Product Name: Gabapentine
Product Code: N03AX12
Pharmaceutical Form: Capsule
CAS Number: 60142-96-3
Other descriptive name: GABAPENTIN
Concentration unit: mg milligram(s)
Concent
Sponsors
HOSPICES CIVILS DE LYON
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients may have either o a diagnosis of oculopalatal tremor (OPT), following a focal brainstem lesion. o a clinically definite, laboratory-supported diagnosis of MS according to the Mac Donald criteria - All patients may present a chronic acquired pendular nystagmus due to OPT or MS, 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Ophthalmological o Other ophthalmological disorder that could impair corrected visual acuity (Maculopathy, Retinopathy…) - Neurological o Ongoing seizure o Severe handicap that does not allow sitting down position for 1 hour - Suicidal behavior or risk - Treatment o Under memantine or gabapentin medication (these medications should have been stopped for at least 1 week for gabapentin and 3 weeks for memantine) o Under morphine, N-methyl-D-aspartate such as amantadine, ketamine or dextromethorphan o Steroid medication for a current relapse (beginning 3 weeks previously and terminating at the end of the trial duration o Known hypersensitivity to memantine or gabapentin - General o Unstable medical state o Patient with a galactose intolerance, a lapp lactase deficiency or glucose-galactose malabsorption o Moderate renal failure (creatinine clearance 5 time normal values) - Pregnancy (on questioning) - Tutelage or any legal protection measure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of gabapentine and memantine on nystagmus in a OPT patients population and a MS population.;Secondary Objective: To compare the effect of gabapentine and memantine on nystagmus in a OPT patients population versus a MS patients population. To describe the tolerance of the investigational drugs in OPT and MS patients. ;Primary end point(s): Clinical examination :All patients undergo a thorough ophthalmic examination including fundi and best corrected visual acuity measurement Eye movement recording :A quantitative recording of eye position for each eye is performed in all patients in using a 3D infrared video-oculography (25 Hz frequency) and a 2D infrared video-oculagraphy (100 Hz) (Synapsys®, Marseille, France). Eye movements analysis:Based on the trajectories of each eye projected in the three planes the following values are extracted: • The dominant plane (H, V or T) as the plane in which the largest amplitude of eye oscillation was measured. • The mean amplitude and the mean peak velocity calculated on 20 consecutive cycles of nystagmus in the dominant plane. • The frequency of pendular nystagmus, manually calculated over a 30 sec period. For the purpose of analyzing more precisely the frequency of nystagmus, we also perform a Fast Fourier Transform of 2D eye position data (100 Hz frequency recording) VFQ-25 :To examine vision-specific health-related quality of life we use the 25-Item National Eye Institute Visual Function Questionnaire (VFQ-25), which has been validated in patients with optic neuritis (Ma, Shea et al. 2002). Oscillopsia measurement :Patients will estimate monocularly and binocularly the direction and amplitude of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location. Tolerance :Tolerance of medications and side effects will be recorded. | — |
Countries
France
Contacts
Public ContactZUBLENA
HOSPICES CIVILS DE LYON
Outcome results
None listed