Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097318
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-11-20
Brief Title:
Safety Study of Interferon Beta 1a to for Acute Stroke
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Recombinant Human Interferon Beta-1a in Acute Ischemic Stroke A Dose Escalation and Safety Study
Status:
COMPLETED
Status Verified Date:
2011-04-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the safety of the drug interferon beta 1a in patients with acute ischemic stroke to determine the highest dose patients can tolerate without serious side effects and to determine the best way to give the medication Ischemic stroke is caused by a blood clot blocking the flow of blood to brain tissue causing loss or impairment of bodily functions governed by the affected part of the brain Interferon beta 1a is approved for use in patients with multiple sclerosis to prevent further brain injury caused by inflammation the drug may also help prevent further brain injury in patients with acute stroke
Patients between 18 and 85 years of age who have had a stroke and who can begin taking the study drug within 24 hours of onset of stroke symptoms may be eligible for this study Candidates are screened with a medical history physical examination and neurological examinations blood tests electrocardiogram and brain imaging with magnetic resonance imaging MRI or computed tomography CT scans
Participants are randomly assigned to receive either interferon beta 1a or placebo an inactive substance For every five patients enrolled four receive the study drug and one receives placebo The dose of interferon beta 1a is increased in successive groups of patients so that the first group to enter the study receives 11 micrograms mcg of the drug the next receives 22 mcg then 44 mcg 66 mcg and 88 mcg All patients receive their first dose intravenously through a vein additional doses are given subcutaneously under the skin
During their hospital stay all participants receive standard medical care for stroke have neurological checks every 6 hours and have continuous heart monitoring To prevent fever they receive medication such as Tylenol before each dose of interferon beta 1a or placebo and every 6 hours as needed while taking the study drug Routine blood tests are done at 3 and 7 days after the first dose of study drug or at discharge if the patient leaves the hospital before 7 days and again at 14 21 and 28 days Neurological examinations are done 24 hours after starting the study medication then every day for 14 days and again on day 28
After discharge from the hospital patients are seen by a nurse every day foan 14 days after the first medication dose They are contacted by phone on days 17 and 21 On day 28 they return to the hospital as an outpatient for a neurological assessment and blood tests
Patients between 18 and 85 years of age who have had a stroke and who can begin taking the study drug within 24 hours of onset of stroke symptoms may be eligible for this study Candidates are screened with a medical history physical examination and neurological examinations blood tests electrocardiogram and brain imaging with magnetic resonance imaging MRI or computed tomography CT scans
Participants are randomly assigned to receive either interferon beta 1a or placebo an inactive substance For every five patients enrolled four receive the study drug and one receives placebo The dose of interferon beta 1a is increased in successive groups of patients so that the first group to enter the study receives 11 micrograms mcg of the drug the next receives 22 mcg then 44 mcg 66 mcg and 88 mcg All patients receive their first dose intravenously through a vein additional doses are given subcutaneously under the skin
During their hospital stay all participants receive standard medical care for stroke have neurological checks every 6 hours and have continuous heart monitoring To prevent fever they receive medication such as Tylenol before each dose of interferon beta 1a or placebo and every 6 hours as needed while taking the study drug Routine blood tests are done at 3 and 7 days after the first dose of study drug or at discharge if the patient leaves the hospital before 7 days and again at 14 21 and 28 days Neurological examinations are done 24 hours after starting the study medication then every day for 14 days and again on day 28
After discharge from the hospital patients are seen by a nurse every day foan 14 days after the first medication dose They are contacted by phone on days 17 and 21 On day 28 they return to the hospital as an outpatient for a neurological assessment and blood tests
Detailed Description:
Objectives Recombinant human interferon beta-1a IFN-Beta1a is an FDA approved treatment for patients with relapsing remitting multiple sclerosis in whom the safety profile is well characterized The actions of IFN-Beta1a to inhibit pro-inflammatory cytokines and prevent blood brain barrier disruption suggest a therapeutic potential in ischemic stroke and recent experimental evidence supports that effect This study will be the first clinical trial exposure of patients with acute stroke to IFN-Beta1a The purpose of this study is to investigate the safety of IFN-Beta1a RebifRegistered Trademark in patients with acute ischemic stroke
Study Population Patients age 18-85 years with probable or definite acute ischemic cerebrovascular syndrome within 24 hours of onset will be studied
Design This is a randomized double-blind placebo-controlled sequential dose escalation phase 1 trial Five dose cohorts of 5 patients 41 active placebo will be studied at 11 mcg 22 mcg 44 mcg 66 mcg and 88 mcg administered daily for 7 days The first dose will be administered intravenously and subsequent doses will be administered subcutaneously Patients will be pre-medicated to prevent fevers a common complication of interferon treatment since fever may worsen stroke outcome Patients will be monitored for adverse events and neurological outcomes up to 28 days from onset of treatment Data will be reviewed in an ongoing fashion by a data safety monitoring board DSMB Dose escalation will be continuous unless drug-related toxicity reaches a predetermined level of one dose-limiting adverse event 1 of 4 treated within a dose cohort in which case a second cohort of 5 patients 41 will be treated at that dose The study will be terminated at a dose level at which 2 of 4 or 3 of 8 patients on active treatment have a severe dose limiting toxicity or when all planned dose cohorts have been completed
Outcome Measures Expected common toxicities with IFN-Beta1a treatment are flu-like symptoms eg fevers myalgias headaches fatigue and injection site reactions With long term administration liver function abnormalities and leukopenia may occur and these will also be monitored Toxicity will be graded according to the NCI criteria as well as study specific criteria defined in section 7a Dose limiting toxicities will be considered any serious adverse event or grade 3 toxicity judged to be probably or definitely related to study medication or grade 4 or 5 toxicity judged to be possibly probably or definitely related to study medication or any of the predefined study specific criteria Serum levels of IFN-Beta1a and serum markers of IFN-Beta1a activity will be measured to characterize the pharmacokinetics and pharmacodynamics of IFN-Beta 1a in acute stroke patients
Study Population Patients age 18-85 years with probable or definite acute ischemic cerebrovascular syndrome within 24 hours of onset will be studied
Design This is a randomized double-blind placebo-controlled sequential dose escalation phase 1 trial Five dose cohorts of 5 patients 41 active placebo will be studied at 11 mcg 22 mcg 44 mcg 66 mcg and 88 mcg administered daily for 7 days The first dose will be administered intravenously and subsequent doses will be administered subcutaneously Patients will be pre-medicated to prevent fevers a common complication of interferon treatment since fever may worsen stroke outcome Patients will be monitored for adverse events and neurological outcomes up to 28 days from onset of treatment Data will be reviewed in an ongoing fashion by a data safety monitoring board DSMB Dose escalation will be continuous unless drug-related toxicity reaches a predetermined level of one dose-limiting adverse event 1 of 4 treated within a dose cohort in which case a second cohort of 5 patients 41 will be treated at that dose The study will be terminated at a dose level at which 2 of 4 or 3 of 8 patients on active treatment have a severe dose limiting toxicity or when all planned dose cohorts have been completed
Outcome Measures Expected common toxicities with IFN-Beta1a treatment are flu-like symptoms eg fevers myalgias headaches fatigue and injection site reactions With long term administration liver function abnormalities and leukopenia may occur and these will also be monitored Toxicity will be graded according to the NCI criteria as well as study specific criteria defined in section 7a Dose limiting toxicities will be considered any serious adverse event or grade 3 toxicity judged to be probably or definitely related to study medication or grade 4 or 5 toxicity judged to be possibly probably or definitely related to study medication or any of the predefined study specific criteria Serum levels of IFN-Beta1a and serum markers of IFN-Beta1a activity will be measured to characterize the pharmacokinetics and pharmacodynamics of IFN-Beta 1a in acute stroke patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-N-0036 | None | None | None |