CerebrolysinPhase 4E-COMPASSNCT01996761
Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
A Phase 4 study testing porcine brain peptide (Cerebrolysin) in people with Cerebrolysin, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrolysin
- What is being tested?
- porcine brain peptide (Cerebrolysin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Feb 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1st cortical or subcortical unilateral infarction (supratentorial lesion)
- Confirmed by CT or MRI
- Subacute stage: less than 1 week
- Moderate to severe motor function involvement-total of FMA: 0-84
- Age: between 18 and 80 years
- Inpatients
Who cannot join
- Progressive or unstable stroke
- Pre-existing and active major neurological disease
- Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
- A history of significant alcohol or drug abuse in the prior 3 years
- Advanced liver, kidney, cardiac, or pulmonary disease
- A terminal medical diagnosis consistent with survival < 1 year
Show all 12Show fewer
- Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale
- Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
- Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin
- Current enrolment in another therapeutic study of stroke or stroke recovery
- Total serum bilirubin > 4 mg/dL, alkaline phosphatase > 250 U/L, SGOT/AST > 150 U/L, SGPT/ALT > 150 U/L, or creatinine > 3.5 mg/dL; or cardiopulmonary deficits large enough to interfere with reasonable participation in physiotherapy during the trial.
- Previous porcine brain peptide administration history
Trial locations and contacts
1 site in 1 country.
About this study
This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke.
- Conditions
- Cerebrolysin
- Being tested
- porcine brain peptide (Cerebrolysin), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
porcine brain peptide (Cerebrolysin)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | Study Group 1: 30ml Cerebrolysin Receives: Drug: porcine brain peptide (Cerebrolysin) |
| Study Group 2 | Placebo comparator | Study Group 2: Placebo (0.9% NaCl) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the improvement ratio of Fugl-Meyer assessment
Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke
Measured: after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CerebrolysinStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Hee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996761
- Sponsor's protocol ID
- 2010-09-084-001
- Acronym
- E-COMPASS
- Status last verified
- May 2016
- First submitted
- 5 Nov 2013
- Last updated
- 11 May 2016
- Results posted
- No
Publications
Chang WH, Park CH, Kim DY, Shin YI, Ko MH, Lee A, Jang SY, Kim YH. Cerebrolysin combined with rehabilitation promotes motor recovery in patients with severe motor impairment after stroke. BMC Neurol. 2016 Mar 2;16:31. doi: 10.1186/s12883-016-0553-z.
PubMed 26934986
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
- ClinicalTrials.gov ID
- NCT01996761
- Acronym / sponsor ID
- E-COMPASS / 2010-09-084-001
- Conditions
- Cerebrolysin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Nov 2013 (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.
This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Drug: porcine brain peptide (Cerebrolysin)Study Group 1: 30ml Cerebrolysin |
| Study Group 2 | Placebo comparator | Drug: PlaceboStudy Group 2: Placebo (0.9% NaCl) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1st cortical or subcortical unilateral infarction (supratentorial lesion)
- Confirmed by CT or MRI
- Subacute stage: less than 1 week
- Moderate to severe motor function involvement-total of FMA: 0-84
- Age: between 18 and 80 years
Key exclusion criteria (12 listed)
- Progressive or unstable stroke
- Pre-existing and active major neurological disease
- Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
- A history of significant alcohol or drug abuse in the prior 3 years
- Advanced liver, kidney, cardiac, or pulmonary disease
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 |
|---|---|---|
| porcine brain peptide (Cerebrolysin) | Drug | Study Group 1 |
| Placebo | Drug | Study Group 2 |
Primary outcome
the improvement ratio of Fugl-Meyer assessment
Time frame: after 3 weeks
Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke
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 11 May 2016.
- Derived from this study: PubMed 26934986Chang WH, Park CH, Kim DY, Shin YI, Ko MH, Lee A, Jang SY, Kim YH. Cerebrolysin combined with rehabilitation promotes motor recovery in patients with severe motor impairment after stroke. BMC Neurol. 2016 Mar 2;16:31. doi: 10.1186/s12883-016-0553-z.
Related trials for Cerebrolysin
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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.
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 4 study testing porcine brain peptide (Cerebrolysin) in people with Cerebrolysin, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 12 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 11 May 2016. 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 South Korea. 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?
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?
the improvement ratio of Fugl-Meyer assessment (time frame: after 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01996761, which also lists 1 linked publication.
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 11 May 2016.