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Kinase Inhibitor
BLZ945 for ALS
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disease duration from symptoms onset no longer than 48 months at the screening visit
Male and female participants who are 18 years old or older at screening, and who are diagnosed with familial or sporadic ALS according to the World Federation of Neurology Revised El Escorial criteria of either bulbar or limb onset
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 281
Awards & highlights
Study Summary
This trial will test if a new drug is safe and tolerated by people with ALS, as well as if it causes a response in the brain cells that are associated with the disease.
Who is the study for?
This trial is for adults over 18 with familial or sporadic ALS diagnosed per World Federation of Neurology criteria, within 48 months of symptom onset. Participants must have completed a prior treatment period, be on stable approved ALS therapies for at least 30 days, and not have significant heart issues, autoimmune diseases, infections like HIV or tuberculosis, liver disease, drug abuse history in the past year, or be pregnant/nursing.Check my eligibility
What is being tested?
The study tests BLZ945's safety and its effect on brain microglia in ALS patients. It's an open-label trial where all participants receive multiple doses of BLZ945 to observe how well they tolerate it and how their brain cells involved in immune defense respond.See study design
What are the potential side effects?
While specific side effects are not listed here, typical concerns may include allergic reactions to the medication components (BLZ945), potential organ inflammation due to immune response alterations caused by the drug therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My symptoms started less than 4 years ago.
Select...
I am 18 or older and have been diagnosed with ALS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 281
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 281
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 5: Adverse events related to ECM accumulation
Cohort 5: Change from baseline in Left Ventricular Ejection Fraction
Cohort 5: Change from baseline in cardiac valve function
+3 moreSecondary outcome measures
Cohorts 1-4: Renal Clearance (CLR) of BLZ945
Cohorts 1-5: CYP2C8 genotyping
Cohorts 1-5: Number of patients with adverse events
+4 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Cohort 5 Arm #2 extended treatment periodExperimental Treatment1 Intervention
Dose 4, Regimen 2 of BLZ945
Group II: Cohort 5 Arm #2Experimental Treatment1 Intervention
Dose 4, Regimen 2 of BLZ945
Group III: Cohort 5 Arm #1 extended treatment periodExperimental Treatment1 Intervention
Dose 4, Regimen 1 of BLZ945
Group IV: Cohort 5 Arm #1Experimental Treatment1 Intervention
Dose 4, Regimen 1 of BLZ945
Group V: Cohort 4Experimental Treatment1 Intervention
Dose 4 of BLZ945
Group VI: Cohort 3Experimental Treatment1 Intervention
Dose 3 of BLZ945
Group VII: Cohort 2Experimental Treatment1 Intervention
Dose 2 of BLZ945
Group VIII: Cohort 1Experimental Treatment1 Intervention
Dose 1 of BLZ945
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,294 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
595 Patients Enrolled for Amyotrophic Lateral Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of important heart rhythm problems shown on an ECG.I do not have active GI conditions or a history of esophageal cancer.I am currently pregnant or breastfeeding.I have tested positive for HIV.I have been on a stable dose of my ALS treatment for at least 30 days.I have a history of vasculitis or autoimmune diseases like RA, SLE.I don't have any serious health issues besides ALS that would stop me from joining the study.I am a man and will use a condom during and for 14 days after treatment.My symptoms started less than 4 years ago.I have had kidney problems in the past or currently.I am on blood thinners that cannot be stopped for medical tests.I am capable of becoming pregnant and have a negative pregnancy test.I am currently having thoughts about harming myself.I do not have abnormal heart or blood vessel findings that would stop me from continuing treatment.I have not had recent serious heart issues or severe heart failure.I am using effective birth control if I can become pregnant.I have a history of heart valve problems.I am not planning to start another ALS therapy within the next 24 weeks.I haven't taken any experimental drugs recently.My screening tests show no signs of active or latent tuberculosis.I am 18 or older and have been diagnosed with ALS.I have liver disease or injury.I haven't had a serious infection in the last month.Your blood test results show significant problems.You have tested positive for hepatitis B or hepatitis C.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 5 Arm #1 extended treatment period
- Group 2: Cohort 5 Arm #2
- Group 3: Cohort 5 Arm #1
- Group 4: Cohort 5 Arm #2 extended treatment period
- Group 5: Cohort 1
- Group 6: Cohort 2
- Group 7: Cohort 3
- Group 8: Cohort 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 the FDA support this medication as a form of treatment?
"This treatment falls into Phase 2 of clinical trials, meaning that while there is some evidence supporting its safety, there is none yet for efficacy. Our team at Power have given it a score of 2."
Answered by AI
How many individuals are being given this opportunity to participate in the research?
"Yes, the clinical trial is currently recruiting patients. The study was posted on December 30th, 2019 with the latest edit taking place on October 5th, 2022. They are looking for 46 individuals across 2 sites."
Answered by AI
What goals does this research hope to achieve?
"The primary objective of the trial, as measured over a Day -42 to Day 84 timeframe, is Cohort 5's change in cardiac valve function from baseline. Additionally, the study will measure secondary outcomes including plasma pharmacokinetics ( PK)of BLZ945-T1/2 for Cohorts 1-5 , AUC for Cohorts 1-5 , and Cmax for Cohorts 1-5 ."
Answered by AI
Are there any unfilled slots in this clinical trial?
"Yes, the trial sponsor is still recruiting participants for this study according to information on clinicaltrials.gov. The listing was first posted on December 30th, 2019 and last updated on October 5th, 2020."
Answered by AI
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