We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Pendular Nystagmus in OPT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02466191
Recruitment Status : Completed
First Posted : June 9, 2015
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Pendular nystagmus corresponds to an enduring to and fro eye oscillation without resetting quick phases. The most common causes of acquired pendular nystagmus (APN) are multiple sclerosis (MS) and focal brainstem lesions (oculopalatal tremor, OPT). Based on pathophysiological hypothesis, pharmacological treatments of acquired nystagmus have been thoroughly proposed over different publications of cases, series, reviews or expert opinions. Acquired pendular nystagmus underwent the most rigorous treatment trials, leading to the proposal of gabapentin or memantine as valuable drugs. Whether gabapentin and memantine are effective in APN associated with OPT remains unclear, since none of the previous studies has evaluated the effect of these medications in a group of OPT patients. However, this is an important issue in prospect to a clinical use of these medications. In the current study, the investigators aim is to evaluate the effect of gabapentin and memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on visual acuity and vision-specific health-related quality of life score, in a group of OPT patients

Condition or disease Intervention/treatment Phase
Pendular Nystagmus Oculopalatal Tremor Drug: Memantine Drug: Gabapentin Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Oculopalatal Tremor: a Controled Open-label Study
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: memantine first
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: Memantine
Experimental: gabapentin first
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Velocity, amplitude and frequency of nystagmus using eye movement recording [ Time Frame: at Day 17-21 ]
  2. Velocity, amplitude and frequency of nystagmus using eye movement recording [ Time Frame: at Day 34-42 ]
  3. Velocity, amplitude and frequency of nystagmus using eye movement recording [ Time Frame: at Day 64-79 ]
  4. Velocity, amplitude and frequency of nystagmus using eye movement recording [ Time Frame: at Day 81-100 ]

Secondary Outcome Measures :
  1. Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire [ Time Frame: at Day 17-21 ]
  2. Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire [ Time Frame: at Day 34-42 ]
  3. Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire [ Time Frame: at Day 64-79 ]
  4. Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire [ Time Frame: at Day 81-100 ]
  5. subjective measure of oscillopsia [ Time Frame: at Day 17-21 ]
  6. subjective measure of oscillopsia [ Time Frame: at Day 34-42 ]
  7. subjective measure of oscillopsia [ Time Frame: at Day 64-79 ]
  8. subjective measure of oscillopsia [ Time Frame: at Day 81-100 ]
  9. far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location. [ Time Frame: at Day 17-21 ]
  10. far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location. [ Time Frame: at Day 34-42 ]
  11. far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location. [ Time Frame: at Day 64-79 ]
  12. far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location. [ Time Frame: at Day 81-100 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of oculopalatal tremor (OPT), following a focal brainstem lesion.
  • All patients may present a chronic acquired pendular nystagmus due to OPT, 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.
  • For women: efficient contraception during the experimental time and in the two month following treatment withdrawal.

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466191


Locations
Layout table for location information
France
Hospices Civils de Lyon
Lyon, France, 69002
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Caroline TILIKETE, Pr Hospices Civils de Lyon
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02466191    
Other Study ID Numbers: 69HCL14_0438
2014-005548-17 ( EudraCT Number )
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Keywords provided by Hospices Civils de Lyon:
nystagmus
pharmacological trial
multiple sclerosis
oscillopsia
Additional relevant MeSH terms:
Layout table for MeSH terms
Tremor
Nystagmus, Pathologic
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Gabapentin
Memantine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents