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

NCT ID: NCT00928954

Last Updated: 2016-07-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nystagmus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gabapentin

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

Group Type ACTIVE_COMPARATOR

gabapentin

Intervention Type DRUG

increasing to 1200 mg/day

Memantine

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

Group Type ACTIVE_COMPARATOR

memantine

Intervention Type DRUG

increasing to 40 mg/day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

gabapentin

increasing to 1200 mg/day

Intervention Type DRUG

memantine

increasing to 40 mg/day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neurontin Nameda

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John Leigh

R. John Leigh, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard J Leigh, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Veterans Affairs Medical Center, 10701 East Boulevard

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIHR01EY06717

Identifier Type: OTHER

Identifier Source: secondary_id

NIH R01 EYO6717

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NIHR01EY06717

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Visual Attention and Eye Movements
NCT03298737 ENROLLING_BY_INVITATION
Brain Changes in Blepharospasm
NCT00500799 COMPLETED