Efficacy of Cerebrolysin to Recover Aphasia in Patients with Acute Ischemic Stroke

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20251122002

Enrollment

Registered

2025-11-22

Start date

2025-06-25

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Acute ischemic stroke, left MCA territory, confirmed by CT or MRI with aphasia Cerebrolysin, Stroke, Aphasia

Interventions

Cerebrolysin 30 mL diluted in 0.9% NSS to a total volume of 250 mL IV infusion once daily for 10 consecutive days. ,250 mL 0.9% NSS

IV infusion schedule

Experimental Drug,Placebo Comparator Drug

Cerebrolysin,Control

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age is more than or equal to 20 years., 2.Acute ischemic stroke, left MCA territory, confirmed by CT/MRI, 3.Aphasia confirmed by WAB and clinical SLP assessment, 4.Right-handed dominance, 5.Thai as native language; premorbid effective communication, 6.Enrollment within 7 days from stroke onset, 7.Received guideline concordant acute stroke care, 8.Informed consent by patient or legally authorized representative (LAR)

Exclusion criteria

Exclusion criteria: 1.Prior stroke is more than 1 episode or unstable intracranial hemorrhage, 2Uncontrolled epilepsy, 3.Severe hepatic (AST/ALT is more than 4 times of ULN) or renal failure (creatinine is more than 4 mg/dL), 4.Preexisting major neurodegenerative or severe psychiatric disorders, 5.Use of other neuroprotective agents (e.g., edaravone, citicoline) in the acute period, 6.Known hypersensitivity to Cerebrolysin, 7.Uncorrected severe visual/hearing impairment interfering with testing, 8.Any life-threatening comorbidity per investigator judgment

Design outcomes

Primary

Measure	Time frame
Change in WAB AQ from baseline to Day 90 90 days Western Aphasia Battery-Aphasia Quotient (WAB-AQ)	—

Secondary

Measure	Time frame
Change in WAB AQ at Day 45 day 45 Western Aphasia Battery-Aphasia Quotient (WAB-AQ),Responder rates (WAB AQ gain more than or equal to5 points) at Days 45 and 90 day 45, day 90 Western Aphasia Battery-Aphasia Quotient (WAB-AQ),Change in NIHSS and BI at Days 45 and 90. day 45, day 90 NIH Stroke Score,mRS distribution at Days 45 and 90 day 90 mRS score,Safety after every drug infusion headache, nausea, dizziness, etc.	—

Measure

Time frame

Change in WAB AQ at Day 45 day 45 Western Aphasia Battery-Aphasia Quotient (WAB-AQ),Responder rates (WAB AQ gain more than or equal to5 points) at Days 45 and 90 day 45, day 90 Western Aphasia Battery-Aphasia Quotient (WAB-AQ),Change in NIHSS and BI at Days 45 and 90. day 45, day 90 NIH Stroke Score,mRS distribution at Days 45 and 90 day 90 mRS score,Safety after every drug infusion headache, nausea, dizziness, etc.

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Countries

Thailand

Contacts

Public ContactSakolawat Jaroenpakdee

Nakornping Hospital

sakolawat.jp@cpird.in.th0991237588

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026