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

Phase 1

• Conditions: PENDULAR NYSTAGMUS IN PATIENTS WITH MULTIPLE SCLEROSIS OR OCULOPALATAL TREMOR; MedDRA version: 18.0Level: PTClassification code 10029864Term: NystagmusSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-005548-17-FR
• Lead Sponsor: HOSPICES CIVILS DE LYO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-03
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-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

Exclusion Criteria

-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
-General
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified