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Sphingosine-1-Phosphate Receptor Modulator
Fingolimod for Cerebral Edema After Stroke (FITCH Trial)
Phase < 1
Waitlist Available
Led By Stacey Q Wolfe, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptoms less than 24 hours prior to enrollment if all eligibility criteria are met. An unknown time of onset is exclusionary. Use the time the patient was last known to be well for patients that awaken from sleep with symptoms.
Be older than 18 years old
Must not have
Active use of antineoplastic, immunosuppressive, or immunomodulating therapies.
Primary intraventricular hemorrhage without significant intraparenchymal component.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up visit 4 between days 351 and 379
Summary
This trial will test if the drug fingolimod is safe and effective in treating primary spontaneous intracerebral hemorrhage.
Who is the study for?
This trial is for adults with a recent (less than 24 hours ago) spontaneous brain hemorrhage larger than 15 mL, not caused by trauma or other specific conditions. Participants must be able to give consent (or have it given by a legal representative), have stable blood pressure, and no severe heart issues, clotting disorders, or incompatible implanted devices.
What is being tested?
The study tests the safety and effectiveness of a single dose of Fingolimod compared to placebo in patients with primary spontaneous intracerebral hemorrhage. It aims to see if Fingolimod can reduce brain swelling after such bleeding occurs.
What are the potential side effects?
Fingolimod may cause side effects like headache, flu-like symptoms, back pain, increased liver enzymes which might indicate liver injury, cough and diarrhea. It could also affect heart rate especially after the first dose.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My symptoms started less than 24 hours ago, or I woke up with them today.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently using cancer, immune-suppressing, or immune-modifying treatments.
Select...
I had a bleed inside the chambers of my brain without affecting the brain tissue much.
Select...
I currently have an active viral infection.
Select...
I have a specific type of heart rhythm problem.
Select...
My liver is not working properly.
Select...
I have a diagnosed brain blood vessel issue or recent brain bleed.
Select...
I do not have a growing brain tumor causing increased pressure.
Select...
I have severe brain damage with minimal consciousness.
Select...
I have a permanent blood clotting disorder.
Select...
I am under 18 years old.
Select...
I am currently taking medication for heart rhythm problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow-up visit 4 between days 351 and 379
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-up visit 4 between days 351 and 379
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of neurologic decline
Rate of nosocomial infections (UTI, sepsis, and pneumonia)
Secondary study objectives
Change in lymphocyte subpopulations
Hematoma volume - CT
Hematoma volume - MRI
+12 moreSide effects data
From 2007 Phase 4 trial • 552 Patients • NCT001108907%
Diarrhoea
7%
Vomiting
3%
Nausea
3%
Nasopharyngitis
3%
Muscle spasms
1%
Angina pectoris
1%
Myocardial infarction
1%
Pericarditis
1%
Chest discomfort
1%
Hernia
1%
Jaundice
1%
Gastroenteritis
1%
Arteriovenous fistula thrombosis
1%
Joint dislocation
1%
Joint injury
1%
Shunt occlusion
1%
Shunt thrombosis
1%
Blood potassium increased
1%
Fluid retention
1%
Hypovolaemia
1%
Pancreatic carcinoma
1%
Cognitive disorder
1%
Skin ulcer
1%
Catheter placement
1%
Hypertensive crisis
1%
Arteriovenous fistula occlusion
1%
Orthostatic hypotension
1%
Cardiac arrest
1%
Chest pain
1%
Pyrexia
1%
Cholecystitis
1%
Arthritis bacterial
1%
Bacterial sepsis
1%
Fall
1%
Back pain
1%
Pain in extremity
1%
Dyspnoea
1%
Nephrectomy
1%
Hypotension
1%
Peripheral ischaemia
1%
Atrial flutter
1%
Cardiac asthma
1%
Abdominal pain
1%
Sudden cardiac death
1%
Transplant rejection
1%
Perianal abscess
1%
Pneumonia
1%
Urinary tract infection
1%
Ankle fracture
1%
Arteriovenous fistula site complication
1%
Rib fracture
1%
Cerebral infarction
1%
Gastrointestinal haemorrhage
1%
Catheter related infection
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Care
Cinacalcet
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fingolimod GroupExperimental Treatment2 Interventions
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Group II: Control GroupPlacebo Group2 Interventions
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fingolimod 0.5 mg
2020
Completed Phase 4
~3640
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,361 Previous Clinical Trials
1,039,664 Total Patients Enrolled
Stacey Q Wolfe, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have trouble swallowing or severe nausea that makes taking pills difficult.I am currently using cancer, immune-suppressing, or immune-modifying treatments.I have signed, or my legal representative has signed, the consent form to participate.I had a bleed inside the chambers of my brain without affecting the brain tissue much.I have a confirmed diagnosis of a large brain bleed not in the cerebellum.My symptoms started less than 24 hours ago, or I woke up with them today.I currently have an active viral infection.I have a specific type of heart rhythm problem.My liver is not working properly.I have a diagnosed brain blood vessel issue or recent brain bleed.I do not have a growing brain tumor causing increased pressure.I have severe brain damage with minimal consciousness.People who are in prison.You have a heart device that can't be used with the MRI scans required for the study.You have a history of traumatic brain injury leading to bleeding in the brain.Your baseline QTc interval is longer than 500 milliseconds.I have a permanent blood clotting disorder.I am under 18 years old.Your platelet count is less than 100,000 or your INR is higher than 1.4.You have a Glasgow Coma Scale (GCS) score that is higher than a certain number when you first arrive for the study.You have a historical score of 0 or 1 on the Modified Rankin Scale (mRS).I am currently taking medication for heart rhythm problems.I have been hospitalized for a serious heart condition in the last 6 months.You have a high score on the NIH Stroke Scale when you first show symptoms of a stroke.Your blood pressure should be below 200 mmHg when you join the study.
Research Study Groups:
This trial has the following groups:- Group 1: Fingolimod Group
- Group 2: Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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