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

HOSPICES CIVILS DE LYO0 个研究点开始时间: 2015年6月3日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•-Patients may have either
•oa diagnosis of oculopalatal tremor (OPT), following a focal brainstem lesion.
•oa 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

•-Ophthalmological
•oOther ophthalmological disorder that could impair corrected visual acuity (Maculopathy, Retinopathy…)
•-Neurological
•oOngoing seizure
•oSevere handicap that does not allow sitting down position for 1 hour
•-Suicidal behavior or risk
•-Treatment
•oUnder memantine or gabapentin medication (these medications should have been stopped for at least 1 week for gabapentin and 3 weeks for memantine)
•oUnder morphine, N-methyl-D-aspartate such as amantadine, ketamine or dextromethorphan
•oSteroid medication for a current relapse (beginning 3 weeks previously and terminating at the end of the trial duration
•oKnown hypersensitivity to memantine or gabapentin
•oUnstable medical state
•oPatient with a galactose intolerance, a lapp lactase deficiency or glucose-galactose malabsorption
•oModerate renal failure (creatinine clearance < 50 mL/min on bioassay dated from less than one month)
•oRecent heart infarction (<3months)
•oUnstable congestive heart insufficiency
•oUnstable arterial hypertension
•oLeucopenia (<2500/mm3)
•oTransaminase increase (>5 time normal values)
•-Pregnancy (on questioning)
•-Tutelage or any legal protection measure

发起方

HOSPICES CIVILS DE LYO