What is the mechanism of action of this treatment?

Ehlers-Danlos Syndrome (EDS) patients often suffer from chronic pain, joint hypermobility, and connective tissue fragility. Treatments like IV oxytocin are being studied for their analgesic properties, which work by modulating pain perception in the central nervous system. Oxytocin, in particular, activates oxytocin receptors (OTRs) that can inhibit nociceptive (pain) signals, potentially providing significant pain relief. This is crucial for EDS patients as effective pain management can greatly improve their quality of life, allowing for better mobility and reduced discomfort.

What side effects are associated with this type of intervention?

Common treatments for Ehlers-Danlos Syndrome (EDS) that modulate pain perception in the central nervous system include analgesics, antidepressants, and anticonvulsants. Analgesics, such as opioids, can cause side effects like nausea, constipation, drowsiness, and potential dependency. Antidepressants, including tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs), may lead to side effects such as dry mouth, weight gain, fatigue, and sexual dysfunction. Anticonvulsants, like gabapentin and pregabalin, can cause dizziness, drowsiness, and peripheral edema. IV Oxytocin, being studied for its analgesic properties, may have side effects such as nausea, headache, and hypotension.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically for the treatment of Ehlers-Danlos Syndrome (EDS). Management of EDS primarily focuses on symptomatic treatment, including pain management, physical therapy, and cardiovascular monitoring. While IV oxytocin is being studied for its potential analgesic properties in EDS, there are no similar FDA-approved treatments that modulate pain perception in the central nervous system specifically for EDS. Pain management in EDS often involves the use of standard analgesics, physical therapy, and other supportive measures.

What other types of research exist?

Promising alternatives to IV Oxytocin for Ehlers-Danlos Syndrome patients include: 1) Spinal Cord Stimulation (SCS), which has shown effectiveness in chronic pain management through modulation of pain pathways. 2) Low-dose Ketamine Infusion, which has been used for acute painful crises and may offer benefits for chronic pain through NMDA receptor antagonism. 3) Capsaicin Cream (10%), which has provided long-term pain relief in other chronic pain conditions and could be considered for EDS-related pain.

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Hormone Therapy

Oxytocin for Ehlers-Danlos Syndrome (EDS-OXY Trial)

Phase 1 & 2

Recruiting

Led By Brendan Lee, MD, PhD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Premenopausal Females, Age >18 years

Pain level greater that pain score of 4 out of 10 on a Numeric Rating Scale in at least two of the following locations: back, neck, shoulders, elbows, wrist, hand joints, hips, knees, ankles, on most days over the 3 months preceding enrollment.

Must not have

History of known cardiac arrhythmias (except for asymptomatic sinus tachycardia and sinus bradycardia)

A confirmed clinical diagnosis of autoimmune disorders that lead to joint inflammation and joint pain such as SLE, RA, psoriatic arthritis, ankylosing spondylitis, scleroderma, and enteropathic arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for each arm we will compare pain levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. this difference will be compared between the two treatment arms.

Summary

This trial is testing if a treatment can help reduce long-term pain in women with a specific condition. The treatment might work by influencing how the body processes pain and emotions. It has been increasingly investigated for its potential in pain relief, with initial studies focusing on its effects during labor and breastfeeding.

Who is the study for?

This trial is for premenopausal females over 18 with hypermobile Ehlers-Danlos syndrome who experience chronic pain in multiple joints. Participants must have a stable pain management regimen and agree to use non-hormonal contraception. Excluded are those with certain heart conditions, autoimmune disorders causing joint inflammation, pregnancy, lactation, or allergies to oxytocin.

What is being tested?

The study tests the effect of intravenous oxytocin on chronic pain against a placebo in patients with Hypermobile Ehlers-Danlos Syndrome (hEDS). It's designed to see if oxytocin can reduce their pain levels more effectively than a placebo.

What are the potential side effects?

Possible side effects of IV oxytocin may include allergic reactions, changes in heart rate or rhythm, and local reactions at the infusion site. Since it's being compared to a placebo, some participants might not experience any active drug-related side effects.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman over 18 and have not gone through menopause.

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I have had pain greater than 4/10 in my back, neck, or joints most days in the last 3 months.

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I have had pain greater than 4/10 in my back, neck, or joints most days in the last 3 months.

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My pain medication dose is stable and won't increase during the study.

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I have been diagnosed with hypermobile EDS based on the 2017 criteria.

Exclusion Criteria

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

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I have a history of heart rhythm problems, except for harmless fast or slow beats.

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I have been diagnosed with an autoimmune disorder that causes joint pain.

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I am currently using hormonal birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for each arm we will compare anxiety levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. this difference will be compared between the two treatment arms.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for each arm we will compare anxiety levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. this difference will be compared between the two treatment arms.

This trial's timeline: 3 weeks for screening, Varies for treatment, and for each arm we will compare anxiety levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. this difference will be compared between the two treatment arms. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in participant's subjective reported chronic pain

Secondary study objectives

Change in activity level

Heart rate

Anxiety

+1 more

Other study objectives

Change in participant's pain levels assessed by numerical rating

Change in participant's pain levels by evaluating pain experience

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: OxytocinActive Control1 Intervention

Treatment infusion: IV 1IU Oxytocin in 200ml of 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)

Group II: PlaceboPlacebo Group1 Intervention

Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)

0 / 8Eligibility 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

Ehlers-Danlos Syndrome (EDS) patients often suffer from chronic pain, joint hypermobility, and connective tissue fragility. Treatments like IV oxytocin are being studied for their analgesic properties, which work by modulating pain perception in the central nervous system. Oxytocin, in particular, activates oxytocin receptors (OTRs) that can inhibit nociceptive (pain) signals, potentially providing significant pain relief. This is crucial for EDS patients as effective pain management can greatly improve their quality of life, allowing for better mobility and reduced discomfort.

[Changes in somatosensory evoked potentials in patients with vertebrogenic pain syndromes treated by electroacupuncture].Primary Erythromelalgia Treated With 10% Capsaicin Cream: A Case Report and a 10-Year Follow-Up.Inhibition of nociceptive dural input to the trigeminocervical complex through oxytocinergic transmission.