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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT01744444
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pendular Nystagmus Patients With Multiple Sclerosis	Drug: Memantine; Drug: Gabapentin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Memantine first	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.
Experimental: Gabapentin first	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.

Outcome Measures

Primary Outcome Measures

1. Velocity using eye movement recording [at Day17-21]

2. Velocity using eye movement recording [at Day34-42]

3. Velocity using eye movement recording [at Day64-79]

4. Velocity using eye movement recording [at Day81-100]

Secondary Outcome Measures

1. Functional score on questioning [at Day17-21, Day34-42, Day64-79, Day81-100]

2. Subjective measure of oscillopsia [at Day17-21, Day34-42, Day64-79, Day81-100]

3. Far visual acuity [at Day17-21, Day34-42, Day64-79, Day81-100]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Neurologique Unité de Neuro-Ophtalmologie	Bron		France	69677

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Caroline Tilikete, Pr, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT01744444
• Other Study ID Numbers: 2012.737
• First Posted: Dec 6, 2012
• Last Update Posted: Dec 18, 2013
• Last Verified: Dec 1, 2013

• Additional relevant MeSH terms: Multiple Sclerosis; Nystagmus, Pathologic; Sclerosis; Gabapentin; Memantine

Study Results

No Results Posted as of Dec 18, 2013