Effect of Namenda on Short Term Memory and Attention in Patients With Mild to Moderate Traumatic Brain Injury - Full Text View

Sponsors and Collaborators:	University of Missouri-Columbia Forest Laboratories
Information provided by:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00462228

Purpose

The purpose of this study is to determine whether memantine (Namenda) improves memory and attention in patients with mild to moderate traumatic brain injury.

Condition	Intervention	Phase
Traumatic Brain Injury	Drug: memantine	Phase IV

MedlinePlus related topics: Memory Traumatic Brain Injury

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Double-Blind Cross-Over Study of the Effect of Namenda on Short Term Memory and Attention in Patients With Mild to Moderate Traumatic Brain Injury, Protocol NAM-MD-44

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:

Improvements from baseline scores after 6 and 12 weeks of memantine compared to placebo on the Hopkins Verbal Learning Test Revised (HVLT-R). [ Time Frame: baseline, 6 weeks, and 12 weeks after beginning Namenda or placebo ] [ Designated as safety issue: No ]
Improvements from baseline scores after 6 and 12 weeks of memantine compared to placebo on the Brief Visuo-Spatial Memory Test Revised (BVLT-R). [ Time Frame: baseline, 6 weeks, 12 weeks after beginning Namenda or placebo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvements from baseline scores after 6 and 12 weeks of memantine compared to placebo on the Trail Making Test Part A and Part B. [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
Improvements from baseline scores after 6 and 12 weeks of memantine compared to placebo on the Symbol Digit Modality Test. [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AB Subjects begin with treatment A and crossover to treatment B.	Drug: memantine After randomization of the subject, subjects will be titrated up to 20 mg of memantine or placebo (provided by Forest Laboratories) per day. Memantine and placebo are provided as 5 mg tablets. Subjects will be started at 5 mg per day. The dose will be increased by 5 mg increments to 10 mg per day (5 mg twice per day), 15 mg per day (5 mg and 10 mg as separate doses) and 20 mg per day (10 mg twice per day). The minimum interval between dose increases will be one week. Subjects will take memantine or placebo for 12 weeks during each part of the crossover study. Subjects are randomized to begin either memantine or placebo in each arm of the study, arm AB or arm BA. Study personnel are blinded to A and B treatment identity.
BA Subjects begin with treatment B and crossover to treatment A.	Drug: memantine Subjects will have the same dosage regimen for memantine or placebo as listed above. In arm BA, subjects will start with treatment B and crossover to treatment A.

Arms

Assigned Interventions

AB

Subjects begin with treatment A and crossover to treatment B.

Drug: memantine

After randomization of the subject, subjects will be titrated up to 20 mg of memantine or placebo (provided by Forest Laboratories) per day. Memantine and placebo are provided as 5 mg tablets. Subjects will be started at 5 mg per day. The dose will be increased by 5 mg increments to 10 mg per day (5 mg twice per day), 15 mg per day (5 mg and 10 mg as separate doses) and 20 mg per day (10 mg twice per day). The minimum interval between dose increases will be one week. Subjects will take memantine or placebo for 12 weeks during each part of the crossover study. Subjects are randomized to begin either memantine or placebo in each arm of the study, arm AB or arm BA. Study personnel are blinded to A and B treatment identity.

BA

Subjects begin with treatment B and crossover to treatment A.

Drug: memantine

Subjects will have the same dosage regimen for memantine or placebo as listed above. In arm BA, subjects will start with treatment B and crossover to treatment A.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients will have persistent memory and attention deficits due to a closed traumatic brain injury not less than one year prior to entrance in the study.
Meet or exceed American Congress of Rehabilitation Medicine (ACRM) criteria for mild TBI.
Mini-Mental State Exam (MMSE) score of 20-27.
Galveston Orientation and Amnesia Test (GOAT) score of at least 75.
Be of sufficient cognitive ability to complete neuropsychological tests.
Male or female, 18-50 years of age.
Females of childbearing potential must use acceptable means of birth control and have a negative screening b-HCG pregnancy test. Acceptable birth control includes hormonal birth control (such as oral birth control pills, implanted or injected contraceptives), an intrauterine device (IUD), surgical sterilization (such as tubal ligation or hysterectomy), a spermicide with barrier methods (condoms or diaphragm), or a partner who has had a vasectomy.
Patients taking donepezil (Aricept) or rivastigmine (Exelon) must be at a steady state dose for a minimum of six months.
Patients taking any other medication(s) affecting cognition must be at a steady state dose for a minimum of two months.
Able to provide written informed consent.
Able to read, write, and speak in English.
Willing and able to comply with the physician's instructions for all aspects of the study.

Exclusion Criteria:

Patients must not have any medical or psychiatric disorder that in the opinion of the PI would interfere with or bias the assessment of efficacy or place their health at risk when placed on the memantine (Namenda) regimen.
Patients with a history of seizure are excluded.
Patients with a history of severe renal insufficiency are excluded.
Patients must not have taken any experimental drug within the last 30 days prior to entering the protocol.
Patients must not have taken any drug known to have major organ system toxicity within the last 30 days prior to entering the protocol.
Women who are pregnant, nursing, or intend to become pregnant during the study are excluded.
Patients with a penetrating TBI are excluded.
Patients whose screening laboratory values are 1.5 times greater than ULN are excluded.
Patients with systolic blood pressure greater than 180 mm Hg or less than 90 mm Hg or diastolic blood pressure greater than 105 mm Hg or less than 50 mm Hg at the screening visit are excluded.
Concomitant use of amantadine (Symmetrel) is prohibited and a washout period of 4 weeks is required before study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462228

Contacts

Contact: Fred Murdock, Ph.D.	573-884-5217	murdockf@health.missouri.edu
Contact: Anne Bonnett, RN, CCRC	573-884-6119	bonnetta@health.missouri.edu

Locations

United States, Missouri
University of Missouri-Columbia	Recruiting
Columbia,, Missouri, United States, 65212
Principal Investigator: S. Jon Rupright, D.O.
Principal Investigator: George R. Johnstone, Ph.D.

Sponsors and Collaborators

University of Missouri-Columbia

Forest Laboratories

Investigators

Principal Investigator:	S. Jon Rupright, D.O.	Associate Professer, Clinical Physical Medicine & Rehabilitation, School of Medicine, University of Missouri-Columbia
Principal Investigator:	George R. Johnstone, Ph.D.	Professor, Department of Health Psychology, University of Missouri-Columbia

More Information

Responsible Party:	Dept. of Physical Medicine and Rehabilitation, University of Missouri-Columbia ( S. Jon Rupright, D.O., Associate Professor of Clinical Physical Medicine and Rehabilitation )
Study ID Numbers:	NAM-MD-44
Study First Received:	April 10, 2007
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00462228
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:

traumatic brain injury
memory
attention

Study placed in the following topic categories:

Craniocerebral Trauma
Excitatory Amino Acids
Dopamine
Wounds and Injuries
Memantine

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Antiparkinson Agents
Excitatory Amino Acid Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009