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Monoclonal Antibodies

Alemtuzumab for Multiple Sclerosis

Q: To what purpose is [F-18]PBR06 most often put?

<p>[F-18]PBR06 is most often used to treat <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, however it can also help patients suffering from conditions such as kidney transplants, b-lymphocyte <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, and chronic t cell rejection.</p>

Phase 1 & 2

Waitlist Available

Led By Tarun Singhal, MD

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

Age 18-60 years

Enrolled to start treatment with alemtuzumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 18 months

Awards & highlights

Study Summary

This trial is looking at the effect of a drug called alemtuzumab on microglial activation in patients with multiple sclerosis. They are testing the hypothesis that alemtuzumab reduces microglial activation, which may help with symptoms like cognitive fatigue.

Who is the study for?

This trial is for people aged 18-60 with Relapsing Remitting Multiple Sclerosis who are starting alemtuzumab treatment. It's not for those who've had a recent relapse, other neurological disorders, head injury, substance abuse, bipolar disease or schizophrenia. Pregnant or nursing women and individuals with MRI-incompatible devices or claustrophobia are also excluded.Check my eligibility

What is being tested?

The study tests how alemtuzumab affects microglial activation in MS patients using PET scans with [F-18]PBR06. The main goal is to see if the drug reduces brain inflammation which could slow down the disease progression and improve cognition including fatigue.See study design

What are the potential side effects?

While specific side effects of [F-18]PBR06 aren't detailed here, typical risks may include allergic reactions to the tracer or discomfort from the PET scan procedure itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I am starting treatment with alemtuzumab.

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I have been diagnosed with Relapsing Remitting Multiple Sclerosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Expanded Disability Status Scale (EDSS) change

Minimal Assessment of Cognitive Function in MS (MACFIMS) change

Modified Fatigue Impact Scale (MIFS) change

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Relapsing Remitting Multiple Sclerosis starting AlemtuzumabExperimental Treatment1 Intervention

Patients with Relapsing Remitting Multiple Sclerosis (RRMS) (defined by International Panel Criteria), age 18-60 years, enrolled to start treatment with alemtuzumab. Subjects will undergo [F-18]PBR06 PET scans at baseline, 6 months and 18 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alemtuzumab

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyIndustry Sponsor

524 Previous Clinical Trials

85,619 Total Patients Enrolled

34 Trials studying Multiple Sclerosis

6,561 Patients Enrolled for Multiple Sclerosis

Brigham and Women's HospitalLead Sponsor

1,615 Previous Clinical Trials

11,470,820 Total Patients Enrolled

14 Trials studying Multiple Sclerosis

6,756 Patients Enrolled for Multiple Sclerosis

Tarun Singhal, MDPrincipal InvestigatorBrigham and Women's Hospital

5 Previous Clinical Trials

176 Total Patients Enrolled

4 Trials studying Multiple Sclerosis

157 Patients Enrolled for Multiple Sclerosis

Media Library

Alemtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03983252 — Phase 1 & 2

Multiple Sclerosis Research Study Groups: Relapsing Remitting Multiple Sclerosis starting Alemtuzumab

Multiple Sclerosis Clinical Trial 2023: Alemtuzumab Highlights & Side Effects. Trial Name: NCT03983252 — Phase 1 & 2

Alemtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03983252 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which types of patients would be ideal for this clinical trial?

"The target enrolment for this trial is 10 individuals who have been diagnosed with multiple sclerosis. These potential participants must be between 18-60 years old to meet the age criteria."

Answered by AI

Are there any current vacancies for this experimental treatment?

"Unfortunately, this particular trial is no longer looking for patients to enroll. The study was created on July 1st, 2019 but has not been updated in over a year. However, there are 564 other trials actively recruiting patients with multiple sclerosis and 35 studies that are still looking for participants that match the criteria for [F-18]PBR06."

Answered by AI

How large is the sample size for this experiment?

"This particular trial is no longer enrolling patients. The original posting date was July 1st, 2019 and the most recent update was on June 10th, 2019. However, if you are still interested in participating in medical research, there are 564 other trials related to multiple sclerosis and 35 studies concerning [F-18]PBR06 that are currently recruiting."

Answered by AI

Are geriatric patients welcome in this clinical trial?

"According to the information provided by the clinical trial, patients aged 18-60 are eligible for enrolment. There are 67 other trials available for those under 18 and 419 for people over 65."

Answered by AI

To what purpose is [F-18]PBR06 most often put?

"[F-18]PBR06 is most often used to treat multiple sclerosis, however it can also help patients suffering from conditions such as kidney transplants, b-lymphocyte leukemia, and chronic t cell rejection."

Answered by AI

Can you tell us if [F-18]PBR06 has been successful in previous medical trials?

"As of now, there are 35 ongoing clinical trials for [F-18]PBR06 with 3 Phase 3 trials. Many of the [F-18]PBR06 clinical trials originate from Philadelphia, Pennsylvania; however, across 232 locations worldwide there are studies being conducted for [F-18]PBR06."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple Sclerosis

Tarun Singhal 2019. "Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03983252.

All > Amyotrophic Lateral Sclerosis > Multiple Sclerosis