Effect of Namenda on Short Term Memory and Attention in Patients With Mild to Moderate Traumatic Brain Injury
This study has been terminated.
(The study was stopped due to a lack of additional subjects.)
Sponsor:
University of Missouri-Columbia
Collaborator:
Forest Laboratories
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00462228
First received: April 10, 2007
Last updated: May 9, 2011
Last verified: May 2011
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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 ]
| Enrollment: | 11 |
| Study Start Date: | April 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (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.
Other Name: Namenda
|
|
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.
Other Name: Namenda
|
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 to 27 at the screening visit or a California Verbal Learning Test (CVLT) score for trials 1-5 one standard deviation lower than the age matched normative score. The CVLT score from the medical record may be used for entry criteria if it was obtained one year or more post-TBI and within two years of study entry.
- 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
Locations
| United States, Missouri | |
| University of Missouri-Columbia | |
| Columbia,, Missouri, United States, 65212 | |
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
No publications provided
| Responsible Party: | S. Jon Rupright, D.O., Associate Professor of Clinical Physical Medicine and Rehabilitation, Dept. of Physical Medicine and Rehabilitation, University of Missouri-Columbia |
| ClinicalTrials.gov Identifier: | NCT00462228 History of Changes |
| Other Study ID Numbers: | NAM-MD-44 |
| Study First Received: | April 10, 2007 |
| Last Updated: | May 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Missouri-Columbia:
|
traumatic brain injury memory attention |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Memantine Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013