NCT06087965

Brief Summary

Intracerebral hemorrhage (ICH) is a critical disease of public health importance. Inflammatory mechanisms play a significant role in ICH. Thus, immune targets are supposed to be effective in protecting the neurological function of ICH. Fingolimod, a sphingosine-1-phosphate receptor regulator (FTY720), is an effective immunology modulator. It has been widely used in autoimmune disease and has also been testified effective in ICH who received conservative treatment. The present study aims to evaluate the efficiency and safety of fingolimod for ICH with minimal invasive treatment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2023

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

October 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

October 9, 2023

Last Update Submit

October 17, 2023

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale

    Neurological outcome, range: 0-6. The higher scores mean a worse outcome.

    90 days and 180 days after ICH

Secondary Outcomes (4)

  • The National Institutes of Health Stroke Scale

    90 days and 180 days after ICH

  • Modified Barthel Index

    90 days and 180 days after ICH

  • Montreal Cognitive Assessment Scale

    90 days and 180 days after ICH

  • Volume of perihematomal edema

    Baseline on admission, 7 days and 14 days after ICH

Study Arms (2)

Fingolimod group

EXPERIMENTAL

0.5mg/day oral fingolimod over a course of 3 consecutive days

Drug: Fingolimod

Control group

NO INTERVENTION

No fingolimod will be administered.

Interventions

FingolimodDRUG

0.5mg/day oral fingolimod over a course of 3 consecutive days

Fingolimod group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • spontaneous basal ganglia ICH with volume larger than 20ml;
  • age: 18-80 years;
  • admission Glasgow Coma Scale score: 5-12;
  • admitting to hospital with 24 hours after injury;
  • no fever or signs infection on admission to hospital;
  • admission heart rate≥60/min on admission.

You may not qualify if:

  • refuse follow-up;
  • received operation before admitting to hospital;
  • hemorrhage by tumor, arteriovenous malformation, arterial aneurysm, hematological disease or traumatic brain injury;
  • severe vomiting;
  • mRS\>1 before ICH;
  • prior history of bradycardia;
  • prior history of Atrioventricular block;
  • prior history of traumatic brain injury, craniotomy or stroke;
  • expected lifetime less than 1 year;
  • undergoing antitumor, antiepileptic, immunomodulatory or immunosuppressive therapy;
  • admitting to other ongoing study;
  • systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence;
  • received anticoagulant or antiplatelet therapy within 7 days;
  • intraventricular hemorrhage requires intraventricular catheterization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Study Officials

  • Yan Qu

    Tang-Du Hospital

    STUDY CHAIR

Central Study Contacts

Zhihong Li

CONTACT

+86-13709183909409615390@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 18, 2023

Study Start

October 11, 2023

Primary Completion

June 30, 2025

Study Completion

December 30, 2025

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

the baseline characteristic, treatments and functional outcomes will be shared with other researchers

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
the data will be available after the study is finished for 3 years
Access Criteria
Individual participant data will be shared on a website available to other researchers.