Traumatic Brain InjuryPhase 4NCT02321761
Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury
A Phase 4 study testing Amantadine hydrochloride in people with Traumatic Brain Injury, run by Loewenstein Hospital at 1 site in Israel.
Trial summary
Amantadine hydrochloride is one of the drugs given at rehabilitation programs to people who suffered Acquired Brain Injury in order to expedite recovery and improve functioning. A previous study examined the spatially asymmetric allocation of attention in patients with traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Amantadine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2014to 1 Dec 2018
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-50 yrs
- Patients who were diagnosed with a Diffuse Axonal Injury post TBI
- Severity of injury was defined as moderate to severe
- At least 3 months post injury
- Sufficient cognitive abilities to learn and perform the computerised task.
Who cannot join
- Pyramidal signs on neurological examination
- Localised damage demonstrated on CT
- Contra indication to Amantadine, post traumatic epilepsy, renal failure and patients with known sensitivity to Amantadine
- Patients who were diagnosed with Parkinson's disease or has a first degree family who was diagnosed with Parkinson's.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Loewenstein Rehabilitation Center
Raanana
Sara Lipkin, IRB coordinator, +972-9-7709639, Mirp3@clalit.org.il
About this study
Amantadine hydrochloride is one of the drugs given at rehabilitation programs to people who suffered Acquired Brain Injury in order to expedite recovery and improve functioning.
A previous study examined the spatially asymmetric allocation of attention in patients with traumatic brain injury (TBI). Patients demonstrated significantly worse performance with leftward than with rightward cross-hemi field shifts of attention. This is reminiscence of neglect patients. This difference was significantly reduced during and following treatment. Our objective is to investigate whether Amantadine Hydrochloride is effective in improving allocation of spatial attention and improving function in people with Traumatic Brain Injury.
- Conditions
- Traumatic Brain Injury
- Being tested
- Amantadine hydrochloride
- Keywords
- Amantadine hydrochloride, Rehabilitation, Acquired Brain Injury, TBI
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amantadine hydrochlorideDrug
Also called Symmetrel
Drug dosages: day 0-14 no drug will be given Days 15-21 100 mg Days 22-28 200 mg Days 29-42 400 mg Days 43-56 200 day 57-70 no drug will be given
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Dosage (mg) Day days 0-14 no drug will be given days 15-21 dosage is 100 mg days 22-28 dosage is 200mg days 29-42 dosage is 400mg days 43-56 dosage is 200mg
days 57-70 no drug will be given Receives: Drug: Amantadine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Posner Cueing Task
The study paradigm is based on The Posner Cueing Task, a visual spatial attention task. Identification rates were measured after pre cuing attention to different visual field loci. After pre cuing to a locus 5 degrees into the left or right hemi field, target patterns were presented briefly at the cued location (valid) or on the opposite side (invalid) requiring an attentional shift
Measured: up to day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startJun 2014
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yaron sacher, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321761
- Sponsor's protocol ID
- 15-12-LOE
- Status last verified
- Aug 2018
- First submitted
- 17 Dec 2014
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02321761
- Acronym / sponsor ID
- 15-12-LOE
- Conditions
- Traumatic Brain Injury
- Keywords
- Amantadine hydrochloride, Rehabilitation, Acquired Brain Injury, TBI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 22 Dec 2014 (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.
Amantadine hydrochloride is one of the drugs given at rehabilitation programs to people who suffered Acquired Brain Injury in order to expedite recovery and improve functioning.
A previous study examined the spatially asymmetric allocation of attention in patients with traumatic brain injury (TBI). Patients demonstrated significantly worse performance with leftward than with rightward cross-hemi field shifts of attention. This is reminiscence of neglect patients. This difference was significantly reduced during and following treatment. Our objective is to investigate whether Amantadine Hydrochloride is effective in improving allocation of spatial attention and improving function in people with Traumatic Brain Injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Amantadine hydrochlorideDosage (mg) Day days 0-14 no drug will be given days 15-21 dosage is 100 mg days 22-28 dosage is 200mg days 29-42 dosage is 400mg days 43-56 dosage is 200mg days 57-70 no drug will be given |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-50 yrs
- Patients who were diagnosed with a Diffuse Axonal Injury post TBI
- Severity of injury was defined as moderate to severe
- At least 3 months post injury
- Sufficient cognitive abilities to learn and perform the computerised task.
Key exclusion criteria (4 listed)
- Pyramidal signs on neurological examination
- Localised damage demonstrated on CT
- Contra indication to Amantadine, post traumatic epilepsy, renal failure and patients with known sensitivity to Amantadine
- Patients who were diagnosed with Parkinson's disease or has a first degree family who was diagnosed with Parkinson's.
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 |
|---|---|---|
| Amantadine hydrochlorideAlso: SymmetrelDrug dosages: day 0-14 no drug will be given Days 15-21 100 mg Days 22-28 200 mg Days 29-42 400 mg Days 43-56 200 day 57-70 no drug will be given | Drug | study group |
Primary outcome
The Posner Cueing Task
Time frame: up to day 70
The study paradigm is based on The Posner Cueing Task, a visual spatial attention task. Identification rates were measured after pre cuing attention to different visual field loci. After pre cuing to a locus 5 degrees into the left or right hemi field, target patterns were presented briefly at the cued location (valid) or on the opposite side (invalid) requiring an attentional shift
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amantadine hydrochloride in people with Traumatic Brain Injury, run by Loewenstein Hospital at 1 site in Israel.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Aug 2018. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Posner Cueing Task (time frame: up to day 70). 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 8 Aug 2018.