Ischemic StrokePhase 4NCT02581371
Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm
A Phase 4 study testing Cerebrolysin infusion in people with Ischemic Stroke, run by Clinical Institute of the Brain, Russia at 2 sites in Russia.
Trial summary
The aim of the present clinical phase IV study is to estimate the influence of Cerebrolysin in combination with standard therapy on the dynamics of recovery of the paretic upper limb in patients with acute ischemic stroke. Each patient participates in the study for 176-190 days (approximately 6 months). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Cerebrolysin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesRussia
- Study dates
- Feb 2015to Feb 2017
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A signed patient informed consent;
- Men and women at the age from 45 years to 75 years, inclusive;
- Confirmed (clinically and by MRI of the brain) diagnosis of acute ischemic stroke in the basin of the middle cerebral artery;
- The severity of the stroke from 5 to 24 points on a scale NIHSS;
- Hemiparesis, mainly affecting the upper limbs (not more than 2 points in the evaluation function of the affected hand using the test for hand Frenchay and not more than 2 points in the evaluation of the affected lower limb 6-point scale NIHSS);
- The time from the onset of the disease prior to the introduction of the drug for 72 hours;
- The willingness of patients of both sexes and their sexual partners with preserved reproductive function to use reliable methods of contraception, starting from the moment of inclusion in the study until the completion of participation in this clinical study.
Who cannot join
- The age of 45 years or older than 75 years;
- Known intolerance (including allergic reactions) Cerebrolysin, excipients of the investigational medication;
- Thrombolytic therapy;
- Signs of a hemorrhagic stroke;
- Impairment of consciousness (≥ 2 points during the evaluation under item 1A NIHSS);
- The presence of elements allowing to predict the resolution of neurological symptoms within 24 hours from the first symptoms;
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- Stroke or transient ischemic attack in history;
- The score on the modified Rankin scale to a stroke more than 0 points;
- Concomitant therapy or neuroprotective nootropic drugs;
- New-onset seizures or epilepsy;
- Planned carotid endarterectomy or other operations for secondary prevention of stroke;
- Neurological disease or pathology of the neuromuscular system or any other disease that may affect the interpretation of study results;
- Systemic therapy with biological drugs, including interferon, inductors and/or cytokine/anti-cytokine (e.g., anti-TNF, anti-CD4, IL-10, IL-1, etc.) within 1 month prior to screening;
- Severe concomitant diseases, including cancer, which, in the opinion of the investigator, may affect the estimated parameters;
- Uncontrolled hypertension (SBP ≥ 220 mm Hg. CL. and/or DBP ≥ 120 mm Hg. article in repeated measurements at the screening visit);
- Uncontrolled angina, congestive heart failure or severe arrhythmia;
- The presence of chronic infection (hepatitis B, C or AIDS) in the active form.
- Severely impaired renal function or hepatic impairment (total bilirubin no more than 1.5 hvgn, the level of serum creatinine no more than 2.5 hugn and the levels of ALT, AST, GGT is not higher than 2.5 hvgn);
- Diseases of the blood;
- Mental illness, severe depression or suicide attempts in history;
- The a history of drug addiction, alcoholism and abuse of drugs;
- Contraindications to MRI: metal body, splinters, ferromagnetic implants (pacemakers, automatic dosing of drugs, implanted insulin pumps, artificial anus with a magnetic closure, artificial heart valves with metal elements), steel implants (clamps/clips on blood vessels, artificial joints, metal osteosynthesis devices), hearing AIDS;
- Participation in any other clinical study within 30 days prior to screening or simultaneous participation in other clinical studies;
- Pregnancy, breastfeeding or planning a pregnancy;
- Women and men with preserved reproductive potential who refuse to use effective methods of contraception throughout the study;
- Life expectancy less than 1 year;
- Any disease or circumstances that, in the opinion of the investigator, may interfere with the subject participating in the study or in relation to which participation in the study may be dangerous for the subject;
- Premature withdrowal criteria:
- The research subject may discontinue participation at any time without giving a reason;
- The researcher ahead of time to exclude the patient from the study in the following cases;
- The refusal of the subject from further participation in the study;
- Failure to comply with the subject rules of participation in the study;
- The reasons that emerged during the study and threatening the security of the subject, including those associated with taking study medication adverse events;
- The entities with during the study pregnancy;
- The application of the patient in the study period of any additional neuroprotective and nootropic drugs, drugs from the group of correctors of cerebral blood flow;
- Other reasons arising in the course of the study and prevent the realization of the study according to the Protocol;
- Repeated stroke in the course of the study;
- Subjects who are lost to observation, also belong to prematurely withdrawn from the study.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Clinical Institute of Brain
Beryozovsky, Sverdlovsk Oblast, 620102
Andrey Avgustovich Belkin, Prof.,MD,PhD, (343) 311-3381, clinic@neuro-clinic.ru
Andrey Avgustovich Belkin, Prof.,MD,PhD
- Recruiting
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, Sverdlovsk Oblast, 620102
Andrey Marisovich Alasheev, MD, PhD, +7(905)800-43-02, director@sciencefiles.com
Andrey Marisovich Alasheev, MD, PhD
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study of the Effect of Cerebrolysin® (EVER Neuro Pharma GmbH, Austria) at the Level of Paresis of the Upper Limb When Used in Complex Therapy of Acute Ischemic Stroke
The aim of the present clinical phase IV study is to estimate the influence of Cerebrolysin in combination with standard therapy on the dynamics of recovery of the paretic upper limb in patients with acute ischemic stroke.
Each patient participates in the study for 176-190 days (approximately 6 months). The estimated duration of the study is 2 years.
Read the detailed description
Rehabilitation programs and drug therapy in a stroke aimed, primarily, to the stimulation of the processes of neuroplasticity.
After the screening procedures the eligible patients get randomized in 1 of the 2 groups: either the group of a standard therapy in combination with Cerebrolysin infusions, or the group of a standard therapy in combination with placebo infusions.
The therapy consists of the 3 consecutive periods:
- st - 10 days of daily infusions of Cerebrolysin / placebo;
- nd - 7 days break;
- d - 10 days of daily infusions of Cerebrolysin / placebo.
All participants will attend 7 Visits of the study (Visits 0, 1-6) at 2 sites respectively:
- st - clinical center #1 - Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg
- nd - clinical center #2 - Clinical Institute of Brain, Ekaterinburg.
Patients will be transferred from the 1st site to the 2nd one at the moment of time between Visit 2 and Visit 3.
Patients will undergo traditional laboratory and clinical examination procedures and several specific ones such as scale NIHSS, modified Rankin scale, Barthel index, hand Frenchy assessments. All hand Frenchy assessments will be videotaped for later evaluation by an authorized researcher.
All participants will undergo the procedure of navigational transcranial magnetic stimulation of the brain NBS eXimia Nexstim with the use of an individual 3D brain model created on the Visit 0 MRI results basis.
Neither the patient nor the doctor will know whether they receive an investigational drug or placebo.
- Conditions
- Ischemic Stroke
- Being tested
- Cerebrolysin infusion, Placebo infusion
- Keywords
- Cerebrolysin, neuroplasticity, upper limb, middle cerebral artery, NBS, navigation brain stimulation, paretic limb, stroke, ischemic stroke, rehabilitation, Frenchay Arm Test, NBS eXimia Nexstim, Barthel index
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrolysin infusionDrug
Also called Cerebrolysin
Two 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval
Placebo infusionOther
Also called sodium chloride
Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin infusion | Experimental | Cerebrolysin, solution for injection, 10 ml vials. Two 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval Receives: Drug: Cerebrolysin infusion |
| Placebo infusion | Placebo comparator | Sodium chloride 0.9%, solution for infusion, 100 ml. Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval. Receives: Other: Placebo infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall dynamics of the hand function assessed by the Frenchay Arm Test
Visit 5 data comparison with Visit 0 data
Measured: 6 months
Secondary outcomes (10)
Dynamics of the hand function assessed by the Frenchay Arm Test
Visits 2,3,4 data comparison with Visit 0 data
Measured: 6 months
Dynamics of the grades on the NIHSS scale
Visits 2,3,4,5 data comparison with Visit 0 data
Measured: 6 months
Dynamics of the grades on the modified Rankin scale
Visits 2,3,4,5 data comparison with Visit 0 data
Measured: 6 months
Dynamics of the Barthel index changes
Visits 2,3,4,5 data comparison with Visit 0 data
Measured: 6 months
Dynamics of the cerebral infarction volume decrease according the 3D MRI data
Measured: 6 months
Dynamics of the hemispheres cortex topology of palms motor centers according to navigated transcranial stimulation of the brain (NBS)
Visit 4, 5 data comparison with Visit 3 data
Measured: 6 months
Dynamics of motor response threshold based on the results of navigated transcranial stimulation of the brain (NBS)
Measured: 6 months
Dynamics of the amplitude of motor responses
Measured: 6 months
Dynamics of the latency of motor responses
Measured: 6 months
Frequency, nature and severity of adverse events.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Institute of the Brain, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrey Avgustovich Belkin, Prof.,MD,PhD, Study director, Clinical Institute of Brain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581371
- Sponsor's protocol ID
- COMRIS-ARM-C
- Status last verified
- Oct 2015
- First submitted
- 19 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study of the Effect of Cerebrolysin® (EVER Neuro Pharma GmbH, Austria) at the Level of Paresis of the Upper Limb When Used in Complex Therapy of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02581371
- Acronym / sponsor ID
- COMRIS-ARM-C
- Conditions
- Ischemic Stroke
- Keywords
- Cerebrolysin, neuroplasticity, upper limb, middle cerebral artery, NBS, navigation brain stimulation, paretic limb, stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Clinical Institute of the Brain, RussiaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 21 Oct 2015 (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 aim of the present clinical phase IV study is to estimate the influence of Cerebrolysin in combination with standard therapy on the dynamics of recovery of the paretic upper limb in patients with acute ischemic stroke.
Each patient participates in the study for 176-190 days (approximately 6 months). The estimated duration of the study is 2 years.
Detailed description
Rehabilitation programs and drug therapy in a stroke aimed, primarily, to the stimulation of the processes of neuroplasticity.
After the screening procedures the eligible patients get randomized in 1 of the 2 groups: either the group of a standard therapy in combination with Cerebrolysin infusions, or the group of a standard therapy in combination with placebo infusions.
The therapy consists of the 3 consecutive periods:
- st - 10 days of daily infusions of Cerebrolysin / placebo;
- nd - 7 days break;
- d - 10 days of daily infusions of Cerebrolysin / placebo.
All participants will attend 7 Visits of the study (Visits 0, 1-6) at 2 sites respectively:
- st - clinical center #1 - Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg
- nd - clinical center #2 - Clinical Institute of Brain, Ekaterinburg.
Patients will be transferred from the 1st site to the 2nd one at the moment of time between Visit 2 and Visit 3.
Patients will undergo traditional laboratory and clinical examination procedures and several specific ones such as scale NIHSS, modified Rankin scale, Barthel index, hand Frenchy assessments. All hand Frenchy assessments will be videotaped for later evaluation by an authorized researcher.
All participants will undergo the procedure of navigational transcranial magnetic stimulation of the brain NBS eXimia Nexstim with the use of an individual 3D brain model created on the Visit 0 MRI results basis.
Neither the patient nor the doctor will know whether they receive an investigational drug or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin infusion | Experimental | Drug: Cerebrolysin infusionCerebrolysin, solution for injection, 10 ml vials. Two 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval |
| Placebo infusion | Placebo comparator | Other: Placebo infusionSodium chloride 0.9%, solution for infusion, 100 ml. Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A signed patient informed consent;
- Men and women at the age from 45 years to 75 years, inclusive;
- Confirmed (clinically and by MRI of the brain) diagnosis of acute ischemic stroke in the basin of the middle cerebral artery;
- The severity of the stroke from 5 to 24 points on a scale NIHSS;
- Hemiparesis, mainly affecting the upper limbs (not more than 2 points in the evaluation function of the affected hand using the test for hand Frenchay and not more than 2 points in the evaluation of the affected lower limb 6-point scale NIHSS);
Key exclusion criteria (38 listed)
- The age of 45 years or older than 75 years;
- Known intolerance (including allergic reactions) Cerebrolysin, excipients of the investigational medication;
- Thrombolytic therapy;
- Signs of a hemorrhagic stroke;
- Impairment of consciousness (≥ 2 points during the evaluation under item 1A NIHSS);
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 |
|---|---|---|
| Cerebrolysin infusionAlso: CerebrolysinTwo 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval | Drug | Cerebrolysin infusion |
| Placebo infusionAlso: sodium chlorideTwo 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval | Other | Placebo infusion |
Primary outcome
Overall dynamics of the hand function assessed by the Frenchay Arm Test
Time frame: 6 months
Visit 5 data comparison with Visit 0 data
10 secondary outcomes
Dynamics of the hand function assessed by the Frenchay Arm Test
Time frame: 6 months
Dynamics of the grades on the NIHSS scale
Time frame: 6 months
Dynamics of the grades on the modified Rankin scale
Time frame: 6 months
Dynamics of the Barthel index changes
Time frame: 6 months
Dynamics of the cerebral infarction volume decrease according the 3D MRI data
Time frame: 6 months
Dynamics of the hemispheres cortex topology of palms motor centers according to navigated transcranial stimulation of the brain (NBS)
Time frame: 6 months
Dynamics of motor response threshold based on the results of navigated transcranial stimulation of the brain (NBS)
Time frame: 6 months
Dynamics of the amplitude of motor responses
Time frame: 6 months
Dynamics of the latency of motor responses
Time frame: 6 months
Frequency, nature and severity of adverse events.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Clinical Institute of Brain. Official websiteLink provided by the sponsor.
- Sverdlovsk Regional Clinical Hospital #1. Official websiteLink 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.
Andrey Avgustovich Belkin, Prof.,MD,PhD study director
Clinical Institute of Brain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cerebrolysin infusion in people with Ischemic Stroke, run by Clinical Institute of the Brain, Russia at 2 sites 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 7 inclusion and 38 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 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Contact Andrey Avgustovich Belkin, Prof.,MD,PhD ((343) 311-3381, clinic@neuro-clinic.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall dynamics of the hand function assessed by the Frenchay Arm Test (time frame: 6 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 21 Oct 2015.