Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 19 to 90

Cerebrolysin's effects on language ability in stroke patients with non-fluent aphasia

Official title: Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study

Run by Yonsei University · NCT06897176 · Data updated 2026-11-12

This study tests if adding a medication called cerebrolysin to standard speech therapy can help stroke patients with non-fluent aphasia improve their language skills.

Quick facts

PhasePhase 4
Study typeInterventional
Ages19 Years to 90 Years
SexAll
Enrollment40 (estimated)
SponsorYonsei University
Academic / other
Locations1 site (Seoul)
StatusRecruiting
StartedMarch 12, 2025
Main results expectedJune 14, 2025
Study endsDecember 31, 2027
Registry record updatedMarch 26, 2025
Trial IDNCT06897176 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are right-handed individuals aged 19 to 90 who have experienced their first ischemic or hemorrhagic stroke and are diagnosed with non-fluent aphasia.

Probably not a fit

Patients with multiple previous strokes, significant pre-existing neurogenic or psychiatric disorders, or allergies to cerebrolysin may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of cerebrolysin on language ability in patients suffering from non-fluent aphasia following a stroke. Participants are divided into two groups: one receiving standard speech therapy combined with cerebrolysin, and the other receiving only standard speech therapy as a control. The study aims to measure changes in language ability using the PK-WAB scores before and after treatment. It focuses on patients in the subacute phase of stroke, where language therapy is crucial for recovery.

Why it matters

Potential benefit: If successful, this study could enhance language recovery in stroke patients with non-fluent aphasia, potentially improving their quality of life.

How similar studies have gone: While there is ongoing research into treatments for aphasia, the specific use of cerebrolysin in this context is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients with a first-episodic of ischemic or hemorrhagic stroke
2. Patients with lesions in the left supratentorial area confirmed by CT or MRI
3. Subacute phase within one month of stroke onset
4. Aged between 19 and 90 years
5. Patients diagnosed with non-fluent aphasia through the Korean version of the Western Aphasia Battery
6. Right-handed individuals assessed by the Edinburgh Handedness Inventory
7. Individuals who voluntarily provided written consent for participation in the clinical trial, either personally or through their legal representative
8. Native speakers of Korean

Exclusion Criteria:

1. Individuals with contraindications, including allergies to cerebrolysin
2. Multiple previous episode of stroke that had been managed.
3. Presence of significant pre-existing neurogenic disorders
4. Presence of significant psychiatric disorders such as major depressive disorder, schizophrenia, bipolar disorder, or dementia
5. History of alcohol or other substance abuse within 3 years of onset
6. Presence of severe liver, kidney, heart, or respiratory diseases
7. Medical findings from diagnostic tests indicating any of the following conditions (Total serum bilirubin \> 4mg/dL, alkaline phosphatase \> 250 U/L, SGOT/AST \> 150 U/L. SGPT/ALT \> 150 U/L., or creatinine \>3.5 mg/dL)
8. Presence of an underlying medical condition with a life expectancy of less than 1 year
9. Pregnant or breastfeeding individuals
10. Participation in another therapeutic study

Where it's running

  • Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
    Seoul, South Korea
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.