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

This study has been completed.
Sponsor:
Information provided by:
Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00928954
First received: June 25, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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, Pathological
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:
  • 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 ]
  • Median eye speed during attempted visual fixation, of each eye. [ Time Frame: Measured after two weeks of therapy with either drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's report of whether they think that they have benefitted from either drug treatment [ Time Frame: After two weeks of therapy, for either drug ] [ Designated as safety issue: No ]

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
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 described 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
  More Information

No publications provided

Responsible Party: Richard John Leigh, M.D. (PI), Case Western Reserve University, Cleveland Ohio 44106-5040
ClinicalTrials.gov Identifier: NCT00928954     History of Changes
Other Study ID Numbers: NIHR01EY06717, NIHR01EY06717
Study First Received: June 25, 2009
Last Updated: June 25, 2009
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
Dopamine Agents

ClinicalTrials.gov processed this record on September 16, 2014