Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)

NCT00800514 | Withdrawn DMC

• 1 other identifier: 08-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

perception of time, traumatic brain injury, amantadine

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the Interval Bisection Timing Task.

  12 -16 months

Secondary Outcomes (1)

• The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11).

  12-16 moths

Study Arms (1)

active

EXPERIMENTAL

Drug: amantadine

Interventions

amantadine DRUG

amantadine twice daily

active

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

CHS-Behavioral Health Research

Charlotte, North Carolina, 28211, United States

Location

Related Links

• Click here for more information about this study and CHS

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Oleg V. Tcheremissine, MD

  Carolians HealthCare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: January 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 27, 2022

Record last verified: 2022-02

Locations

US (1)