Recruiting PHASE4 Stroke

New treatment option for Stroke

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

ClinicalTrials.gov ID: NCT06897176

What this study is testing

What is Cerebrolyisin?

Cerebrolyisin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stroke.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
" This study aims to measure changes in language ability after adding cerebrolysin to standard treatment for non-fluent aphasia patients with post-stroke language impairment. The patients are divided into two groups: the experimental group, which receives a combination of standard treatment (speech therapy) and cerebrolysin, and the control group, which only receives standard treatment (speech therapy).
  • Phase 4: studies an already-approved treatment
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 19 to 90

You may be able to join if

  • Patients with a first-episodic of ischemic or hemorrhagic stroke
  • Patients with lesions in the left supratentorial area confirmed by CT or MRI
  • Subacute phase within one month of stroke onset
  • Aged between 19 and 90 years
  • Patients diagnosed with non-fluent aphasia through the Korean version of the Western Aphasia Battery

You likely can't join if

  • Individuals with contraindications, including allergies to cerebrolysin
  • Multiple previous episode of stroke that had been managed.
  • Presence of significant pre-existing neurogenic disorders
  • Presence of significant psychiatric disorders such as major depressive disorder, schizophrenia, bipolar disorder, or dementia
  • History of alcohol or other substance abuse within 3 years of onset
  • Presence of severe liver, kidney, heart, or respiratory diseases
See the full eligibility criteria
Who can join
  • Patients with a first-episodic of ischemic or hemorrhagic stroke
  • Patients with lesions in the left supratentorial area confirmed by CT or MRI
  • Subacute phase within one month of stroke onset
  • Aged between 19 and 90 years
  • Patients diagnosed with non-fluent aphasia through the Korean version of the Western Aphasia Battery
  • Right-handed individuals assessed by the Edinburgh Handedness Inventory
  • Individuals who voluntarily provided written consent for participation in the clinical trial, either personally or through their legal representative
  • Native speakers of Korean
What rules you out
  • Individuals with contraindications, including allergies to cerebrolysin
  • Multiple previous episode of stroke that had been managed.
  • Presence of significant pre-existing neurogenic disorders
  • Presence of significant psychiatric disorders such as major depressive disorder, schizophrenia, bipolar disorder, or dementia
  • History of alcohol or other substance abuse within 3 years of onset
  • Presence of severe liver, kidney, heart, or respiratory diseases
  • 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)
  • Presence of an underlying medical condition with a life expectancy of less than 1 year
  • Pregnant or breastfeeding individuals
  • Participation in another therapeutic study

The study team makes the final eligibility decision.

Where it's taking place

  • Seoul, South Korea

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 19 years to 90 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.