Coma; ProlongedNCT03443037
Benefits of Amantadine in Patients With Coma State
An observational study of Coma; Prolonged and Amantadine, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The study was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coma; Prolonged, Amantadine
- What is being tested?
- amantadine sulphate
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2016to 1 Jul 2019
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the coma state duo to ischemic stroke, brain hemorhage, anoxic brain damage included in this study.
Who may be able to join
- ≥18 years, ≤ 65 years
- GCS score ≤ 8
- Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage
Who cannot join
- <18 years, > 65 years
- Patients admitted to the critical care without diagnosis of coma state
- Patients admitted to critical care with coma state that are not duo to ischemic stroke, brain hemorhage, anoxic brain damage
- Metastatic malignant neoplazm
- Congenital or acquired brain function problem (cerebral palsy, autism etc)
- Patients with amantadine allergy
- Progressive degenerative diseases (Alzheimer, Parkinson diseases etc)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University
Izmir
Kutlay Aydin, MD, +905322649294, kutlayaydin@hotmail.com
Zehra Mermi, MD, +905331680832, zehramermi@gmail.com
About this study
The study was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Patients who received amantadine 200mg/day for fourteen days according to ICU protocols decided by primary physician formed the amantadine group, and the rest of the subjects were included in the control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale and Disability Rating Scale once a week for three months.
- Conditions
- Coma; Prolonged, Amantadine
- Being tested
- amantadine sulphate
- Keywords
- Coma, Disability, amantadine
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amantadine sulphateDrug
| Study group | Role | What they receive |
|---|---|---|
| Amantadine group | Patients admitted to the critical care with diagnosis of coma state who have received amantadin 200 mg / day for fourteen days according to İCU protocols decided by primary physician Receives: Drug: amantadine sulphate | |
| Control group | Patients admitted to the critical care with diagnosis of coma state who haven't received amantadin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glascow Coma Score
Glascow Coma Score
Measured: 1. At the time of enrollment 2. 12 weeks after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Mar 2016
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coma; ProlongedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begum Ergan, Dokuz Eylul University
- Investigators
- Necati Gokmen, MD, Study chair, Dokuz Eylul UniversityKutlay Aydin, Principal investigator, Dokuz Eylul UniversityKutlay Aydin, Study director, Dokuz Eylul UniversityBegum Ergan, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443037
- Sponsor's protocol ID
- 265-SBKAEK
- Status last verified
- Sep 2018
- First submitted
- 16 Feb 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Amantadine in Patients With Coma State
- ClinicalTrials.gov ID
- NCT03443037
- Acronym / sponsor ID
- 265-SBKAEK
- Conditions
- Coma; Prolonged, Amantadine
- Keywords
- Coma, Disability, amantadine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 22 Feb 2018 (actual)
- 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 was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Patients who received amantadine 200mg/day for fourteen days according to ICU protocols decided by primary physician formed the amantadine group, and the rest of the subjects were included in the control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale and Disability Rating Scale once a week for three months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amantadine group | – | Drug: amantadine sulphatePatients admitted to the critical care with diagnosis of coma state who have received amantadin 200 mg / day for fourteen days according to İCU protocols decided by primary physician |
| Control group | – | –Patients admitted to the critical care with diagnosis of coma state who haven't received amantadin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the coma state duo to ischemic stroke, brain hemorhage, anoxic brain damage included in this study.
Key inclusion criteria (3 listed)
- ≥18 years, ≤ 65 years
- GCS score ≤ 8
- Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage
Key exclusion criteria (7 listed)
- <18 years, > 65 years
- Patients admitted to the critical care without diagnosis of coma state
- Patients admitted to critical care with coma state that are not duo to ischemic stroke, brain hemorhage, anoxic brain damage
- Metastatic malignant neoplazm
- Congenital or acquired brain function problem (cerebral palsy, autism etc)
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 sulphate | Drug | Amantadine group |
Primary outcome
Change in Glascow Coma Score
Time frame: 1. At the time of enrollment 2. 12 weeks after the enrollment
Glascow Coma Score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Necati Gokmen, MD study chair
Dokuz Eylul University
Kutlay Aydin principal investigator
Dokuz Eylul University
Kutlay Aydin study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coma; Prolonged and Amantadine, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 6 Sep 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kutlay Aydin, MD (+905322649294, kutlayaydin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glascow Coma Score (time frame: 1. At the time of enrollment 2. 12 weeks after the enrollment). 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 6 Sep 2018.