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

Nystagmus Clinical Trial

Official title:

Investigation and Treatment of Ocular Motor Disorders: Cross-over Comparison of Gabapentin and Memantine as Treatment for Nystagmus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928954
• Other study ID #: NIHR01EY06717
• Secondary ID: NIHR01EY06717NIH
• Status: Completed
• Phase: N/A
• First received: June 25, 2009
• Last updated: July 28, 2016
• Start date: February 2005
• Est. completion date: May 2009

Study information

• Verified date: July 2016
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nystagmus

Intervention

Drug:
• gabapentin
increasing to 1200 mg/day
• memantine
increasing to 40 mg/day

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center, 10701 East Boulevard	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing		After 2 weeks of therapy, for both drugs	No
Primary	Percent Change in Median Eye Speed	Median eye speed during attempted visual fixation by each eye	After 2 weeks of therapy, for both drugs	No