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

NCT00928954 | Completed Results DMC

• 2 other identifiers: NIHR01EY06717NIH R01 EYO6717
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Nystagmus

Keywords

gabapentin; memantine; nystagmus; Drug treatment

Outcome Measures

Primary Outcomes (2)

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

  After 2 weeks of therapy, for both drugs

• Percent Change in Median Eye Speed

  Median eye speed during attempted visual fixation by each eye

  After 2 weeks of therapy, for both drugs

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

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

Drug: gabapentin

Memantine

ACTIVE COMPARATOR

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

Drug: memantine

Interventions

gabapentin DRUG

increasing to 1200 mg/day

Also known as: Neurontin

Gabapentin

memantine DRUG

increasing to 40 mg/day

Also known as: Nameda

Memantine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 years or older) males or females with acquired nystagmus that is degrading their vision

You may not qualify if:

• Pregnant women
• Individuals who cannot describe their visual symptoms, cooperate with testing, or give informed consent
• Individuals with intolerance of gabapentin or memantine

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Veterans Affairs Medical Center, 10701 East Boulevard

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Nystagmus, Pathologic

Interventions

Gabapentin; Memantine

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Amantadine; Adamantane; Bridged-Ring Compounds

Results Point of Contact

• Title: R. John Leigh, M.D.
• Organization: Case Western Reserve University

rjl4@case.edu

216-844-3190

Study Officials

• Richard J Leigh, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: R. John Leigh, M.D.

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: February 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 29, 2016
• Results First Posted: July 29, 2016

Record last verified: 2016-07

Locations

US (1)