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

Primary Purpose

Nystagmus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

gabapentin

memantine

About this trial

This is an interventional treatment trial for Nystagmus focused on measuring gabapentin, memantine, nystagmus, Drug treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Veterans Affairs Medical Center, 10701 East Boulevard

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Gabapentin

Memantine

Arm Description

Increasing dose to 300 mg four times per day (total of 1200 mg/day)

Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).

Outcomes

Primary Outcome Measures

Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing

Percent Change in Median Eye Speed

Median eye speed during attempted visual fixation by each eye

Secondary Outcome Measures

Full Information

NCT ID

NCT00928954

First Posted

June 25, 2009

Last Updated

July 28, 2016

Sponsor

Case Western Reserve University

1. Study Identification

Unique Protocol Identification Number

NCT00928954

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Case Western Reserve University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nystagmus

Keywords

gabapentin, memantine, nystagmus, Drug treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gabapentin

Arm Type

Active Comparator

Arm Description

Increasing dose to 300 mg four times per day (total of 1200 mg/day)

Arm Title

Memantine

Arm Type

Active Comparator

Arm Description

Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).

Intervention Type

Drug

Intervention Name(s)

gabapentin

Other Intervention Name(s)

Neurontin

Intervention Description

increasing to 1200 mg/day

Intervention Type

Drug

Intervention Name(s)

memantine

Other Intervention Name(s)

Nameda

Intervention Description

increasing to 40 mg/day

Primary Outcome Measure Information:

Title

Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing

Time Frame

After 2 weeks of therapy, for both drugs

Title

Percent Change in Median Eye Speed

Description

Median eye speed during attempted visual fixation by each eye

Time Frame

After 2 weeks of therapy, for both drugs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard J Leigh, MD

Organizational Affiliation

Case Western Reserve University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Veterans Affairs Medical Center, 10701 East Boulevard

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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