Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis | RxWiki

Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis

Overview[ - collapse ][ - ]

Purpose	Different treatment trials have been published in acquired nystagmus in the last decade; gabapentin and memantine have been found to be efficient in treating pendular nystagmus in Multiple Sclerosis. The effects of treatments are measured on nystagmus velocity, amplitude, frequency and on visual acuity. None of the trials measured a functional visual score or oscillopsia score. The aim of our study is to evaluate the effect of gabapentin and memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on oscillopsia, visual acuity and vision-specific health-related quality of life score, in 10 patients with multiple sclerosis. The primary object is to find out the best variable to evaluate the efficiency of nystagmus treatment and the secondary, to compare the efficiency of both gabapentin and memantine in a common population of patients.
Condition	Pendular Nystagmus Patients With Multiple Sclerosis
Intervention	Drug: Memantine Drug: Gabapentin
Phase	Phase 2
Sponsor	Hospices Civils de Lyon
Responsible Party	Hospices Civils de Lyon
ClinicalTrials.gov Identifier	NCT01744444
First Received	November 30, 2012
Last Updated	December 17, 2013
Last verified	December 2013

Tracking Information[ + expand ][ + ]

First Received Date	November 30, 2012
Last Updated Date	December 17, 2013
Start Date	November 2012
Estimated Primary Completion Date	July 2013
Current Primary Outcome Measures	Velocity using eye movement recording [Time Frame: at Day17-21] [Designated as safety issue: No] Velocity using eye movement recording [Time Frame: at Day34-42] [Designated as safety issue: No] Velocity using eye movement recording [Time Frame: at Day64-79] [Designated as safety issue: No] Velocity using eye movement recording [Time Frame: at Day81-100] [Designated as safety issue: No]
Current Secondary Outcome Measures	Functional score on questioning [Time Frame: at Day17-21, Day34-42, Day64-79, Day81-100] [Designated as safety issue: No] Subjective measure of oscillopsia [Time Frame: at Day17-21, Day34-42, Day64-79, Day81-100] [Designated as safety issue: No] Far visual acuity [Time Frame: at Day17-21, Day34-42, Day64-79, Day81-100] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis
Official Title	Not Provided
Brief Summary	Different treatment trials have been published in acquired nystagmus in the last decade; gabapentin and memantine have been found to be efficient in treating pendular nystagmus in Multiple Sclerosis. The effects of treatments are measured on nystagmus velocity, amplitude, frequency and on visual acuity. None of the trials measured a functional visual score or oscillopsia score. The aim of our study is to evaluate the effect of gabapentin and memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on oscillopsia, visual acuity and vision-specific health-related quality of life score, in 10 patients with multiple sclerosis. The primary object is to find out the best variable to evaluate the efficiency of nystagmus treatment and the secondary, to compare the efficiency of both gabapentin and memantine in a common population of patients.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Pendular Nystagmus Patients With Multiple Sclerosis
Intervention	Drug: Memantine 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. Drug: Gabapentin 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.
Study Arm (s)	Experimental: Memantine first Experimental: Gabapentin first

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	10
Estimated Completion Date	July 2013
Estimated Primary Completion Date	July 2013
Eligibility Criteria	Inclusion Criteria: - All patients may have a clinically definite, laboratory-supported diagnosis of multiple sclerosis according to the Mac Donald criteria. - All patients may present a chronic acquired pendular nystagmus due to 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 for steroids, gabapentin or memantine. Exclusion Criteria: - Ophthalmological - Other ophthalmological disorder that could impair corrected visual acuity (Maculopathy, Retinopathy…) - Neurological - Ongoing seizure - Severe handicap that does not allow sitting down position for 1 hour - Suicidal behavior or risk - Treatment - Under memantine or gabapentin medication (these medications should have been stopped for at least 1 week for gabapentin and 3 weeks for memantine) - Under morphine, N-methyl-D-aspartate such as amantadine, ketamine or dextromethorphan - Steroid medication for a current relapse (beginning 3 weeks previously and terminating at the end of the trial duration) - Known hypersensitivity to memantine or gabapentin - General - Unstable medical state - Patient with a galactose intolerance, a lapp lactase deficiency or glucose-galactose malabsorption - Moderate renal failure (creatinine clearance < 50 mL/min on bioassay dated from less than one month) - Recent heart infarction (<3months) - Unstable congestive heart insufficiency - Unstable arterial hypertension - Leucopenia (<2500/mm3) - Transaminase increase (>5 time normal values) - Pregnancy (on questioning) - Tutelage or any legal protection measure
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	France

Administrative Information[ + expand ][ + ]

NCT Number	NCT01744444
Other Study ID Numbers	2012.737
Has Data Monitoring Committee	No
Information Provided By	Hospices Civils de Lyon
Study Sponsor	Hospices Civils de Lyon
Collaborators	Not Provided
Investigators	Principal Investigator: Caroline Tilikete, Pr Hospices Civils de Lyon
Verification Date	December 2013

Locations[ + expand ][ + ]