Can treatment with Cerebrolysin improve recovery after acute ischemic stroke?

A randomized, placebo-controlled, double-blind trial to asses the effficacy and safety of CEREBROLYSIN in the treatment of Post-Stroke Cognitive Decline

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88122184

Enrollment

290

Registered

2020-04-29

Start date

2020-06-01

Completion date

Unknown

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiologically confirmed acute ischemic stroke with onset within 72 hours prior to screening Circulatory System Acute ischemic stroke

Interventions

Current interventions as of 15/07/2021: The synopsis of the study is organised in 4 visits: 1. Visit 1: Screening Part 1, Study Day -30 (within 72 h after stroke onset) 2. Visit 2: Screening Part 2 &

10 Infusions, once daily Treatment Cycle 2: Study day 61-70

10 Infusions, once daily Treatment Cycle 3: Study day 121-130

10 Infusions, once daily Treatment Cycle 4: Study day 241-250

10 Infusions, once daily Randomisation and Blinding: This study will be performed under double-blind conditions to keep investigators, other study personnel and patients blinded to treatment allocati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 15/07/2021: 1. Diagnosis of stroke, ischemic in origin (TACS or PACS), confirmed by MRI 2. Onset of Stroke within 72 h prior to screening 3. NIH Stroke Scale score between 5-15 at inpatient admission 4. Pre-stroke mRS of 0 or 1 5. No cognitive impairment prior to stroke with an IQ code score =3 6. Aged between 40 and 80 years, inclusive 7. Patient is willing and able to comply with the protocol for the duration of the study Previous participant inclusion criteria: 1. Acute Ischemic Stroke confirmed by CT 2. Stroke is ischemic in origin - TACS or PACS 3. Onset of Stroke within 72 hours prior to screening 4. NIH Stroke Scale score between 5 and 15 5. Pre-stroke mRS of 0 or 1 6. No cognitive impairment prior to stroke with an IQ code score < 3 7. Age between 40 and 80 years, inclusive 8. Diagnosis of stroke ischemic in origin confirmed by MRI

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 15/07/2021: 1. Previous symptomatic ischaemic stroke or intracranial hemorrhage not related to the index stroke 2. Severe visual or hearing impairment interfering with psychometric test procedures 3. Pre-existing and active major neurological disease (eg. Parkinson’s Disease, Epilepsy) 4. Pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia 5. History of significant alcohol or drug abuse 6. Advanced liver, kidney, cardiac, or pulmonary disease 7. A terminal medical diagnosis with survival 2 13. Aphasia with an NIHSS Item 9 score of =2 14. Treatment with Cerebrolysin or Neuroprotectants in the last 30 days 15. Severe dementia with MMSE Score 2 13. Aphasia with an NIHSS Item 9 score of > 2 14. Treatment with Cerebrolysin or Neuroprotectants in the last 30 days 15. Severe dementia with MMSE Score < 12

Design outcomes

Primary

Measure	Time frame
1. Cognitive function assessed using Stroop Color-Word Test (Stroop, 1935) at 0, 180, 360 days 2. Cognitive function assessed using Trail Making Test Part A (Reitan, 1958) at 0, 180, 360 days 3. Cognitive function assessed using Digit Span Backwards Task (Wechsler adult intelligence scale – third edition) (Wechsler, 1997) at 0, 180, 360 days 4. Cognitive function assessed using Verbal Fluency Test – CFL Version (Benton & Hamsher, 1976) at 0, 180, 360 days 5. Cognitive function assessed using Digit Symbol (Wechsler adult intelligence scale – third edition) (Wechsler, 1997) at 0, 180, 360 days 6. Cognitive function assessed using Rey Auditory Verbal Learning Test (Rey, 1964) at 0, 180, 360 days	—

Measure

Time frame

1. Cognitive function assessed using Stroop Color-Word Test (Stroop, 1935) at 0, 180, 360 days 2. Cognitive function assessed using Trail Making Test Part A (Reitan, 1958) at 0, 180, 360 days 3. Cognitive function assessed using Digit Span Backwards Task (Wechsler adult intelligence scale – third edition) (Wechsler, 1997) at 0, 180, 360 days 4. Cognitive function assessed using Verbal Fluency Test – CFL Version (Benton & Hamsher, 1976) at 0, 180, 360 days 5. Cognitive function assessed using Digit Symbol (Wechsler adult intelligence scale – third edition) (Wechsler, 1997) at 0, 180, 360 days 6. Cognitive function assessed using Rey Auditory Verbal Learning Test (Rey, 1964) at 0, 180, 360 days

—

Secondary

Measure	Time frame
1. Cognitive function assessed using Montreal Cognitive Assessment (MoCA) (Nasreddine, 2005) at 0, 180, 360 days 2. Stroke severity assessed by NIH Stroke Scale (http://www.nihstrokescale.org/) at 0, 180, 360 days 3. Functional outcome assessed by Modified Rankin Score (van Swieten J et al., 1988) at 0, 180, 360 days 4. Emotional status assessed using Hospital Anxiety and Depression Scale (Zigmond, 1983) at 0, 180, 360 days 5. Functional outcome assessed using EQ-5D-5L (Herdman, 2011)at 0, 180, 360 days	—

Measure

Time frame

1. Cognitive function assessed using Montreal Cognitive Assessment (MoCA) (Nasreddine, 2005) at 0, 180, 360 days 2. Stroke severity assessed by NIH Stroke Scale (http://www.nihstrokescale.org/) at 0, 180, 360 days 3. Functional outcome assessed by Modified Rankin Score (van Swieten J et al., 1988) at 0, 180, 360 days 4. Emotional status assessed using Hospital Anxiety and Depression Scale (Zigmond, 1983) at 0, 180, 360 days 5. Functional outcome assessed using EQ-5D-5L (Herdman, 2011)at 0, 180, 360 days

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Countries

Romania

Contacts

Public ContactOlivia Verisezan Rosu

olivia.rosu@ssnn.ro+40744820493

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026