StrokePhase 33CNCT01388738
Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
A Phase 3 study testing citicoline, L-Alpha glycerylphosphorylcholine and cerebrolysin in people with Stroke, run by Clinical Institute of the Brain, Russia at 1 site in Russia.
Trial summary
Ischemic stroke (IS) causes high mortality and severe disability. To improve outcome it's very important to choose the right way of the management of the patient and an appropriate drugs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- citicoline, L-Alpha glycerylphosphorylcholine and cerebrolysin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2011to Nov 2011
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients from 3 to 6 months after ischemic stroke
- hemispheric infarction
- paresis from 2 to 4 scores by Medical Research Council Weakness Scale (MRC)
Who cannot join
- history of seizures
- pregnancy, lactation
- cognitive deficiency (poor compliance)
- acute renal failure
- acute hepatic failure
- oncological history
Show all 10Show fewer
- cardiac pacemakers and other metal implants
- regular intake of any nootropic drugs
- Modified Ashford Scale scores 3 and more
- regular intake of anticonvulsants, neuromuscular relaxants
Trial locations and contacts
1 site in 1 country.
Russia1 site
Clinical Institute of Brain
Yekaterinburg, Sverdlovsk Oblast, 620102
About this study
Official title: Navigation Brain Stimulation (NBS) for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
Ischemic stroke (IS) causes high mortality and severe disability. To improve outcome it's very important to choose the right way of the management of the patient and an appropriate drugs.
There is a large number of the so-called neuroprotective drugs, which were effective in laboratory, but didn't show positive results in clinical studies with using traditional clinical scales scores as a primary outcome measures.
Read more
Specialists suggest, that the investigators could receive better results if the investigators change design of the studies, particularly if the investigators select more precise and sensitive method of assessment.
Aim of this study: to determine the role of navigated brain stimulation (NBS) for evaluation of the changes in the motor centers and motor tracts after administration of different cerebroprotective drugs. (The substances won't be compared to each other).
- Conditions
- Stroke
- Being tested
- citicoline, L-Alpha glycerylphosphorylcholine, cerebrolysin
- Keywords
- Navigation Brain Stimulation (NEXSTIM), cerebroprotective drug effectiveness, acute ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citicolineDrug
citicoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os
L-Alpha glycerylphosphorylcholineDrug
choline alfoscerate IV 1000mg daily 10 days
cerebrolysinDrug
Cerebrolysin IV 10 ml daily 10 days
| Study group | Role | What they receive |
|---|---|---|
| cerebrolysin | Active comparator | IV Receives: Drug: cerebrolysin |
| L-Alpha glycerylphosphorylcholine | Active comparator | IV Receives: Drug: L-Alpha glycerylphosphorylcholine |
| citicoline | Active comparator | IV and per os Receives: Drug: citicoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEP(motor evoked potential) parameter: motor threshold
Measured: 2 months
MEP(motor evoked potential) parameter: latency
Measured: 2 months
MEP(motor evoked potential) parameter: amplitude
Measured: 2 months
Secondary outcomes (9)
Medical Research Council (MRC) Scale for Muscle Strength scores
Measured: 2 months
Barthel index
Measured: 2 months
Modified Rankin Scale (mRS)
Measured: 2 months
Number of Participants with Adverse Events
Measured: 2 months
Change from Baseline in Alpha waves percentage
EEG parameter
Measured: 2 months
Change from Baseline in Beta waves percentage
EEG parameters
Measured: 2 months
Change from Baseline in Delta waves percentage
EEG parameter
Measured: 2 months
Change from Baseline in Theta waves percentage
EEG parameter
Measured: 2 months
Presence of the abnormal epileptiform activity
EEG parameters
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Institute of the Brain, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Nycomed, Veropharm, Ever Neuro Pharma GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388738
- Sponsor's protocol ID
- CIB-NBS-C
- Acronym
- 3C
- Status last verified
- Dec 2011
- First submitted
- 27 Jun 2011
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigation Brain Stimulation (NBS) for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT01388738
- Acronym / sponsor ID
- 3C / CIB-NBS-C
- Conditions
- Stroke
- Keywords
- Navigation Brain Stimulation (NEXSTIM), cerebroprotective drug effectiveness, acute ischemic stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Clinical Institute of the Brain, RussiaUniversity, hospital or other
- Collaborators
- Nycomed, Veropharm, Ever Neuro Pharma GmbH
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Jul 2011 (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.
Ischemic stroke (IS) causes high mortality and severe disability. To improve outcome it's very important to choose the right way of the management of the patient and an appropriate drugs.
There is a large number of the so-called neuroprotective drugs, which were effective in laboratory, but didn't show positive results in clinical studies with using traditional clinical scales scores as a primary outcome measures.
Specialists suggest, that the investigators could receive better results if the investigators change design of the studies, particularly if the investigators select more precise and sensitive method of assessment.
Aim of this study: to determine the role of navigated brain stimulation (NBS) for evaluation of the changes in the motor centers and motor tracts after administration of different cerebroprotective drugs. (The substances won't be compared to each other).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cerebrolysin | Active comparator | Drug: cerebrolysinIV |
| L-Alpha glycerylphosphorylcholine | Active comparator | Drug: L-Alpha glycerylphosphorylcholineIV |
| citicoline | Active comparator | Drug: citicolineIV and per os |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients from 3 to 6 months after ischemic stroke
- hemispheric infarction
- paresis from 2 to 4 scores by Medical Research Council Weakness Scale (MRC)
Key exclusion criteria (10 listed)
- history of seizures
- pregnancy, lactation
- cognitive deficiency (poor compliance)
- acute renal failure
- acute hepatic failure
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 |
|---|---|---|
| citicolineciticoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os | Drug | citicoline |
| L-Alpha glycerylphosphorylcholinecholine alfoscerate IV 1000mg daily 10 days | Drug | L-Alpha glycerylphosphorylcholine |
| cerebrolysinCerebrolysin IV 10 ml daily 10 days | Drug | cerebrolysin |
Primary outcome
MEP(motor evoked potential) parameter: motor threshold
Time frame: 2 months
MEP(motor evoked potential) parameter: latency
Time frame: 2 months
MEP(motor evoked potential) parameter: amplitude
Time frame: 2 months
9 secondary outcomes
Medical Research Council (MRC) Scale for Muscle Strength scores
Time frame: 2 months
Barthel index
Time frame: 2 months
Modified Rankin Scale (mRS)
Time frame: 2 months
Number of Participants with Adverse Events
Time frame: 2 months
Change from Baseline in Alpha waves percentage
Time frame: 2 months
Change from Baseline in Beta waves percentage
Time frame: 2 months
Change from Baseline in Delta waves percentage
Time frame: 2 months
Change from Baseline in Theta waves percentage
Time frame: 2 months
Presence of the abnormal epileptiform activity
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2011.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing citicoline, L-Alpha glycerylphosphorylcholine and cerebrolysin in people with Stroke, run by Clinical Institute of the Brain, Russia at 1 site in Russia.
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 10 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: finished, as of the sponsor's last update on 23 Dec 2011. 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 Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MEP(motor evoked potential) parameter: motor threshold (time frame: 2 months). The study lists 3 primary outcomes in all. 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 23 Dec 2011.