What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include interferon beta-1a, interferon beta-1b, and fingolimod. Interferon beta-1a and beta-1b can cause flu-like symptoms, injection site reactions, liver enzyme elevations, and depression. Fingolimod is associated with headaches, elevated liver enzymes, diarrhea, cough, flu, sinusitis, back pain, and more severe risks like bradyarrhythmia, macular edema, liver injury, and increased susceptibility to infections. These treatments aim to reduce neuroinflammation and slow disease progression in MS patients.

What prior FDA approvals exist?

The FDA has approved several disease-modifying therapies (DMTs) for Multiple Sclerosis, including interferon beta-1a and beta-1b, glatiramer acetate, and fingolimod. These treatments primarily aim to reduce relapse rates and slow disease progression. Fingolimod, in particular, has shown promise in reducing microglial activation, which is relevant to the neuroinflammation targeted by [F-18]DPA-714. Other treatments like alemtuzumab and azathioprine are also used for their immunomodulatory effects, although they do not specifically target TSPO in activated microglia/macrophages.

What other types of research exist?

Promising novel alternatives for Multiple Sclerosis patients include: 1) ONO-4641, a selective agonist for S1P receptors 1 and 5, which has shown efficacy in preclinical models of MS by modulating immune responses and reducing neuroinflammation. 2) EC0746, a folate receptor-targeted aminopterin therapy, which has demonstrated effectiveness in experimental autoimmune encephalomyelitis (EAE) models by targeting activated macrophages. 3) TM5484, a PAI-1 inhibitor, which has shown potential in reducing demyelination and axonal degeneration in MS models.

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PET Radiopharmaceutical

DPA-714 PET/MRI for Chronic Pain and Fatigue (DPA-714 Trial)

Phase 1

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 65 years of age

Be older than 18 years old

Must not have

Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary

Blood or blood clotting disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special imaging test to look for brain inflammation in people with chronic pain and fatigue. The test works by highlighting inflamed areas in the brain, helping researchers see if these patients have more brain inflammation compared to healthy individuals.

Who is the study for?

This trial is for adults aged 18-65 who are healthy or have a diagnosis of Multiple Sclerosis, meet criteria for fibromyalgia or Chronic Fatigue Syndrome. It's not suitable for pregnant or lactating individuals, those with MRI contraindications, severe medical conditions preventing imaging participation, chronic infections like HIV/HCV, recent acute illness requiring antibiotics, cancer diagnoses, blood disorders, autoimmune diseases (except MS), or current involvement in trials with experimental therapies.

What is being tested?

The study tests how a PET radiopharmaceutical called [F-18]DPA-714 maps brain inflammation in patients with chronic pain and fatigue versus healthy controls. The drug binds to specific proteins in activated immune cells within the brain to visualize neuroinflammation using PET/MRI technology.

What are the potential side effects?

As this trial involves diagnostic imaging rather than medication administration directly targeting disease symptoms or progression, typical side effects associated with drugs may not be applicable here. However general risks related to PET/MRI procedures may include discomfort at injection site and potential allergic reactions to the tracer.

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 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an autoimmune disease, except for MS.

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I have a blood or clotting disorder.

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I have a long-term infection like HIV or hepatitis C.

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I have been diagnosed with cancer, including leukemia.

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I haven't needed treatment for an infection in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Multiple Sclerosis SubjectsExperimental Treatment1 Intervention

Group II: Healthy ControlsExperimental Treatment1 Intervention

Group III: Fibromyalgia SubjectsExperimental Treatment1 Intervention

Group IV: Chronic Fatigue Syndrome SubjetsExperimental Treatment1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Sclerosis (MS) treatments often target neuroinflammation, a key factor in disease progression. For instance, masitinib, a selective tyrosine kinase inhibitor, targets mast cells and microglia to reduce neuroinflammation and slow disease progression. Similarly, [F-18]DPA-714 binds to TSPO in activated microglia/macrophages to measure neuroinflammation, highlighting the importance of targeting these cells in MS. Other common treatments, such as interferon beta and glatiramer acetate, modulate immune responses to reduce inflammation and prevent new lesions. These mechanisms are crucial for MS patients as they help manage symptoms, slow disease progression, and improve quality of life by addressing the underlying inflammatory processes.

Imaging of translocator protein upregulation is selective for pro-inflammatory polarized astrocytes and microglia.Neurological S1P signaling as an emerging mechanism of action of oral FTY720 (fingolimod) in multiple sclerosis.