Traumatic Brain InjuryNCT00800514
Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)
A study testing amantadine in people with Traumatic Brain Injury, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- amantadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
CHS-Behavioral Health Research
Charlotte, North Carolina, 28211
About this study
Official title: Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury
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
- Being tested
- amantadine
- Keywords
- perception of time, traumatic brain injury, amantadine
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amantadineDrug
amantadine twice daily
amantadineDrug
amantadine 100 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| active | Experimental | Not described Receives: Drug: amantadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the Interval Bisection Timing Task.
Measured: 12 -16 months
Secondary outcomes (1)
The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11).
Measured: 12-16 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Principal investigator took a position at another institution. No subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oleg V. Tcheremissine, MD, Principal investigator, Carolians HealthCare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800514
- Sponsor's protocol ID
- 08-01
- Status last verified
- Feb 2022
- First submitted
- 1 Dec 2008
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00800514
- Acronym / sponsor ID
- 08-01
- Conditions
- Traumatic Brain Injury
- Keywords
- perception of time, traumatic brain injury, amantadine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator took a position at another institution. No subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active | Experimental | Drug: amantadine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amantadineamantadine twice daily | Drug | active |
| amantadineamantadine 100 mg twice daily | Drug | active |
Primary outcome
The primary outcome measure is the Interval Bisection Timing Task.
Time frame: 12 -16 months
1 secondary outcome
The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11).
Time frame: 12-16 moths
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Click here for more information about this study and CHSLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oleg V. Tcheremissine, MD principal investigator
Carolians HealthCare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amantadine in people with Traumatic Brain Injury, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the Interval Bisection Timing Task. (time frame: 12 -16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.