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

• Sponsor: Case Western Reserve University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00928954
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 50.9
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nystagmus	Drug: gabapentin; Drug: memantine	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, 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
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Nameda

Outcome Measures

Primary Outcome Measures

1. Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing [After 2 weeks of therapy, for both drugs]

2. Percent Change in Median Eye Speed [After 2 weeks of therapy, for both drugs]

   Median eye speed during attempted visual fixation by each eye

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Leigh, R. John Leigh, M.D., Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT00928954
• Other Study ID Numbers: NIHR01EY06717; NIHR01EY06717; NIH R01 EYO6717
• First Posted: Jun 26, 2009
• Last Update Posted: Jul 29, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by John Leigh, R. John Leigh, M.D., Case Western Reserve University: gabapentin; memantine; nystagmus; Drug treatment
• Additional relevant MeSH terms: Nystagmus, Pathologic; Gabapentin; Memantine

Study Results

Participant Flow

Arm/Group Title	Gabapentin First and Then Memantine	Memantine First, Then Gabapentin
Arm/Group Description	Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin. Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine.	Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin. Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine.
Period Title: Overall Study
STARTED	4	6
COMPLETED	4	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin. Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.5 (14.9)
Sex: Female, Male (Count of Participants)
Female	7 70%
Male	3 30%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gabapentin	Memantine
Arm/Group Description	Increasing dose to 300 mg four times per day (total of 1200 mg/day) gabapentin: increasing to 1200 mg/day	Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day). memantine: increasing to 40 mg/day
Measure Participants	10	10
Participant 1, Right Eye	0	0.1
Participant 1, Left Eye	0.2	0.2
Participant 2, Right Eye	0.1	0.2
Participant 2, Left Eye	0.2	0
Participant 3, RIght Eye	-0.1	-0.2
Participant 3, Left Eye	NA	NA
Patricipant 4, RIght Eye	0.3	-0.1
Participant 4, Left Eye	0.1	0.1
Participant 5, Right Eye	0.1	0.2
Particpant 5, Left Eye	0	0.1
Particpant 6, RIght Eye	0.4	0
Particpant 6, Left Eye	0.2	0.2
Particpant 7, Right Eye	-0.1	0.1
Particpant 7, Left Eye	0.1	0.1
Participant 8, Right Eye	0.1	0
Participant 8, Left Eye	0	0.1
Particpant 9, Right Eye	0	0
Participant 9, Left Eye	0	0
Participant 10, Right Eye	-0.1	0.3
Participant 10. Left Eye	0.1	0.2

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gabapentin	Memantine
Arm/Group Description	Increasing dose to 300 mg four times per day (total of 1200 mg/day) gabapentin: increasing to 1200 mg/day	Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day). memantine: increasing to 40 mg/day
Measure Participants	10	10
Participant 1, Right Eye	-59.1	-21.5
Participant 1, Left Eye	-69.8	-35.1
Participant 2, Right Eye	-19.9	-26.0
Participant 2, Left Eye	-19.8	-35.5
Participant 3, RIght Eye	-53.5	-44.6
Participant 3, Left Eye	-41.3	-40.2
Patricipant 4, RIght Eye	-72.8	-8.6
Participant 4, Left Eye	-76.6	11.4
Participant 5, Right Eye	-56.6	-35.5
Particpant 5, Left Eye	-42.0	-26.5
Particpant 6, RIght Eye	-26.0	-44.8
Particpant 6, Left Eye	-25.9	-29.5
Particpant 7, Right Eye	49.5	-29.0
Particpant 7, Left Eye	26.5	-24.1
Participant 8, Right Eye	-0.9	-60.4
Participant 8, Left Eye	-0.7	-24.8
Particpant 9, Right Eye	-39.5	2.2
Participant 9, Left Eye	-44.1	-19.4
Participant 10, Right Eye	159	-80.6
Participant 10. Left Eye	104.4	-79.3

Adverse Events

Arm/Group Title	Gabapentin		Memantine
Arm/Group 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).
All Cause Mortality
	Gabapentin		Memantine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Gabapentin		Memantine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Gabapentin		Memantine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.