Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up visit 4 between days 351 and 379
Awards & highlights
FITCH Trial 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.Check my eligibility
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.See study design
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.
FITCH Trial 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.
FITCH Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of clinically significant cardiac events
Rate of neurologic decline
Rate of nosocomial infections (UTI, sepsis, and pneumonia)
Secondary outcome measures
All cause mortality
Change in lymphocyte subpopulations
Hematoma volume - CT
+14 moreSide effects data
From 2007 Phase 4 trial • 552 Patients • NCT001108907%
Diarrhoea
7%
Vomiting
3%
Nausea
3%
Nasopharyngitis
3%
Muscle spasms
1%
Shunt thrombosis
1%
Pancreatic carcinoma
1%
Angina pectoris
1%
Myocardial infarction
1%
Pericarditis
1%
Jaundice
1%
Shunt occlusion
1%
Gastroenteritis
1%
Hernia
1%
Chest discomfort
1%
Arteriovenous fistula thrombosis
1%
Skin ulcer
1%
Fluid retention
1%
Hypovolaemia
1%
Hypertensive crisis
1%
Cognitive disorder
1%
Joint dislocation
1%
Joint injury
1%
Blood potassium increased
1%
Catheter placement
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
FITCH 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
2008
Completed Phase 4
~3610
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,179 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial offer participation for those below the age of seventy?
"To be eligible for this trial, applicants should fall between the age range of 18 to 80. There are 70 trials that specifically target those under 18 and 401 studies focusing on individuals older than 65 years old."
Answered by AI
How many individuals are involved in this research endeavor?
"Absolutely, the information provided on clinicaltrials.gov attests to this medical study's active recruitment status. The trial was first introduced on August 7th 2020 and last modified on November 28th 2022; 10 patients are required from a single location for enrollment."
Answered by AI
Is this trial of a kind that has not been undertaken before?
"Currently, nine trials for standard of care are running in 135 cities and forty nations. The initial study took place in 2013 under the sponsorship of Novartis Pharmaceuticals; it enrolled 220 participants before achieving its Phase 3 drug approval benchmark. In total, 18491 studies have been finalized since then."
Answered by AI
To whom is enrollment available for this investigation?
"This study is enrolling a total of 10 participants who have intracerebral hemorrhage, hypertensive and lie between the ages 18 to 80."
Answered by AI
What illnesses are typically managed through Standard of Care treatments?
"Carcinoma in situ, active secondary progressive multiple sclerosis (SPMS), and the general disorder of Multiple Sclerosis can all be therapeutically treated using Standard Of Care."
Answered by AI
Are there any past examples of research on accepted therapeutic practices?
"Currently, there are 9 active clinical trials studying the Standard of Care with 3 in their third phase. Although most studies for this treatment take place near Göttingen, Campania, a total of 334 sites around the world have been conducting research on it."
Answered by AI
Is this research endeavor currently enrolling participants?
"Affirmative. Data hosted by clinicaltrials.gov shows that this trial has been actively recruiting since it was originally posted on August 7th 2020 and most recently edited on November 28th 2022. The study is planning to enrol 10 individuals from one location."
Answered by AI
Recent research and studies
Genome BiologyJournal
Moderated Estimation of Fold Change and Dispersion for Rna-seq Data with Deseq2Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger