Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis
This study is currently recruiting participants.
Verified September 2012 by Hospices Civils de Lyon
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01744444
First received: November 30, 2012
Last updated: December 5, 2012
Last verified: September 2012
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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 | Intervention | Phase |
|---|---|---|
|
Pendular Nystagmus Patients With Multiple Sclerosis |
Drug: Memantine Drug: Gabapentin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Hospices Civils de Lyon:
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 ]
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 ]
| Estimated Enrollment: | 10 |
| Study Start Date: | November 2012 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744444
Contacts
| Contact: Caroline Tilikete, Pr | +33 472 118 012 | caroline.tilikete@chu-lyon.fr |
Locations
| France | |
| Hôpital Neurologique Unité de Neuro-Ophtalmologie | Recruiting |
| Bron, France, 69677 | |
| Contact: Caroline TILIKETE, Pr +33 472 118 012 caroline.tilikete@chu-lyon.fr | |
| Principal Investigator: Caroline Tilikete, Pr | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Caroline Tilikete, Pr | Hospices Civils de Lyon |
More Information
No publications provided
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT01744444 History of Changes |
| Other Study ID Numbers: | 2012.737 |
| Study First Received: | November 30, 2012 |
| Last Updated: | December 5, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Multiple Sclerosis Nystagmus, Pathologic Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Ocular Motility Disorders Cranial Nerve Diseases Eye Diseases Pathologic Processes Memantine Gabapentin |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Analgesics Sensory System Agents Peripheral Nervous System Agents Anticonvulsants |
ClinicalTrials.gov processed this record on June 17, 2013