TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR: A CONTROLED OPEN-LABEL STUDY

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2014-005548-17-FR
• Date of registration: 03/06/2015
• Prospective Registration: No
• Primary sponsor: HOSPICES CIVILS DE LYON
• Public title: TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR: A CONTROLED OPEN-LABEL STUDY
• Scientific title: TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR: A CONTROLED OPEN-LABEL STUDY
• Date of first enrolment: 28/04/2015
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005548-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France

Contacts

• Name: ZUBLENA
• Affiliation: HOSPICES CIVILS DE LYON

• Name: ZUBLENA
• Affiliation: HOSPICES CIVILS DE LYON

Key inclusion & exclusion 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:
- 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 < 50 mL/min on bioassay dated from less than one month)
o Recent heart infarction (<3months)
o Unstable congestive heart insufficiency
o Unstable arterial hypertension
o Leucopenia (<2500/mm3)
o Transaminase increase (>5 time normal values)
- Pregnancy (on questioning)
- Tutelage or any legal protection measure



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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)
Concentration type: equal
Concentration number: 300-

Trade Name: EBIXA
Product Name: MEMANTINE
Product Code: N06DX01
Pharmaceutical Form: Coated tablet
INN or Proposed INN: MEMANTINE
CAS Number: 19982-08-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: To compare the effect of gabapentine and memantine on nystagmus in a OPT patients population and a MS population.

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.

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.

Secondary ID(s)

69HCL14-0438

Source(s) of Monetary Support

HOSPICES CIVILS DE LYON