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Cross-over Comparison of Gabapentin and Memantine as Treatment for Acquired Nystagmus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Leigh, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00928954
First received: June 25, 2009
Last updated: July 28, 2016
Last verified: July 2016
  Purpose
Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. The investigators set out to test which of these two drug was more effective by carrying out a double-blind cross-over study. In this way, we could determine which drug worked best in each patient.

Condition Intervention
Nystagmus
Drug: gabapentin
Drug: memantine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation and Treatment of Ocular Motor Disorders: Cross-over Comparison of Gabapentin and Memantine as Treatment for Nystagmus

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing [ Time Frame: After 2 weeks of therapy, for both drugs ] [ Designated as safety issue: No ]
  • Percent Change in Median Eye Speed [ Time Frame: After 2 weeks of therapy, for both drugs ] [ Designated as safety issue: No ]
    Median eye speed during attempted visual fixation by each eye


Enrollment: 10
Study Start Date: February 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gabapentin
Increasing dose to 300 mg four times per day (total of 1200 mg/day)
Drug: gabapentin
increasing to 1200 mg/day
Other Name: Neurontin
Active Comparator: Memantine
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
Drug: memantine
increasing to 40 mg/day
Other Name: Nameda

Detailed Description:
The study entails careful measurements of visual acuity and precise measurements of eye movements, using a contact lens device (magnetic search coil method). In this way, it is possible to make objective and reliable measurements of the effect of each drug, which are unbiased by the investigator or the patient.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (18 years or older) males or females with acquired nystagmus that is degrading their vision

Exclusion Criteria:

  • Pregnant women
  • Individuals who cannot describe their visual symptoms, cooperate with testing, or give informed consent
  • Individuals with intolerance of gabapentin or memantine
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928954

Locations
United States, Ohio
Veterans Affairs Medical Center, 10701 East Boulevard
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Richard J Leigh, MD Case Western Reserve University
  More Information

Responsible Party: John Leigh, R. John Leigh, M.D., Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00928954     History of Changes
Other Study ID Numbers: NIHR01EY06717  NIHR01EY06717  NIH R01 EYO6717 
Study First Received: June 25, 2009
Results First Received: February 9, 2012
Last Updated: July 28, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
gabapentin
memantine
nystagmus
Drug treatment

Additional relevant MeSH terms:
Nystagmus, Pathologic
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Gabapentin
Memantine
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents
Dopamine Agents

ClinicalTrials.gov processed this record on December 02, 2016