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Monoclonal Antibodies
Foralumab Nasal for Multiple System Atrophy
Boston, MA
Phase 2
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with a clinical diagnosis of Clinically Established or Clinically Probable Multiple System Atrophy in accordance with 2022 MDS diagnostic criteria
Age 30 to 85 years, at the time of signing the informed consent
Must not have
Low-affinity binders for translocator protein (TSPO) PET ligands
Diagnosis or suspicion of other cause for Parkinsonism or a known alternate neurologic diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a nasal spray called Foralumab in patients with Multiple System Atrophy (MSA).
See full description
Who is the study for?
This trial is for adults aged 30-85 with Multiple System Atrophy (MSA) who meet specific health criteria like normal blood counts, liver function, and heart rhythm. They must not have significant cognitive impairment or recent serious infections and should be on stable MSA treatment. Pregnant women and those with certain medical conditions or treatments are excluded.Check my eligibility
What is being tested?
The study tests Foralumab Nasal spray in patients with MSA to see if it's safe and effective. It's a Phase 2a trial, which means it focuses on the drug's effectiveness while monitoring side effects in people who have the condition.See study design
What are the potential side effects?
While specific side effects of Foralumab Nasal aren't listed here, common ones may include irritation at the application site, headache, nosebleeds, or other nasal issues due to its administration method.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Multiple System Atrophy according to 2022 standards.
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I am between 30 and 85 years old.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My PET scan shows low TSPO ligand binding.
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I might have Parkinson's due to another health issue or have a different neurological condition.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
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I have a very weak immune system.
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I haven't taken any corticosteroid pills or injections in the last month.
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My brain MRI shows major issues that could affect PET-MRI scans.
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I haven't had a serious heart condition in the last 6 months.
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I have a history of blood or solid tumor cancer.
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I cannot take medications through my nose.
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I have used or might need nasal treatments like corticosteroids or antihistamines recently.
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I have an autoimmune condition.
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I haven't had a serious infection needing treatment in the last 15 days.
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I currently have COVID-19.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Foralumab NasalExperimental Treatment1 Intervention
This study includes a 6-month observational lead-in phase followed by a 6-month open-label treatment phase with Foralumab Nasal.
Find a Location
Closest Location:Brigham and Women's Hospital· Boston, MA· 644 miles
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,691 Previous Clinical Trials
14,778,003 Total Patients Enrolled
2 Trials studying Multiple System Atrophy
69 Patients Enrolled for Multiple System Atrophy