Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)
This study has been terminated.
(Principal investigator took a position at another institution. No subjects enrolled.)
Sponsor:
Carolinas Healthcare System
Information provided by:
Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00800514
First received: December 1, 2008
Last updated: July 18, 2011
Last verified: July 2011
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Purpose
The study will explore the neurocognitive effect of four weeks of treatment with amantadine versus placebo in patients with traumatic brain injury using the Interval Bisection Timing Task. Approximately 16 individuals with traumatic brain injury are expected to participate in this study. Subject participation is expected to last up to 8 weeks with 16 study visits.
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury |
Drug: amantadine |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury |
Resource links provided by NLM:
Further study details as provided by Carolinas Healthcare System:
Primary Outcome Measures:
- The primary outcome measure is the Interval Bisection Timing Task. [ Time Frame: 12 -16 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11). [ Time Frame: 12-16 moths ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 16 |
| Study Start Date: | January 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: active |
Drug: amantadine
amantadine twice daily
Drug: amantadine
amantadine 100 mg twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 to 55 inclusive. History of post-MVA close head TBI. Female subjects must use an acceptable method of contraception during entire study. Acceptable methods of contraception are: history of surgical sterility, postmenopausal status, hormonal contraceptives, or accepted barrier devices (i.e., male/female condom, diaphragm, cervical cap, intrauterine device).
Exclusion Criteria:
- Current or past history of major psychiatric disorder (schizophrenia, bipolar disorder, major depressive disorder)
- Substance use disorder
- Current or past history of serious chronic medical condition (pulmonary (lung), cardiovascular (heart), hepato-renal (liver-kidney) disease, diabetes)
- Seizures
- Smoking one or more packs of cigarettes per day
- If you are pregnant or breastfeeding, or plan to become pregnant during the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800514
Locations
| United States, North Carolina | |
| CHS-Behavioral Health Research | |
| Charlotte, North Carolina, United States, 28211 | |
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
| Principal Investigator: | Oleg V. Tcheremissine, MD | Carolians HealthCare System |
More Information
Additional Information:
No publications provided
| Responsible Party: | Oleg V. Tcheremissine, MD, Carolinas HealthCare System |
| ClinicalTrials.gov Identifier: | NCT00800514 History of Changes |
| Other Study ID Numbers: | 08-01 |
| Study First Received: | December 1, 2008 |
| Last Updated: | July 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Carolinas Healthcare System:
|
perception of time, traumatic brain injury, amantadine |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Amantadine Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Antiviral Agents Anti-Infective Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013