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

Primary Purpose

Hypermobile Ehlers-Danlos Syndrome, Pain Assessment

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypermobile Ehlers-Danlos Syndrome focused on measuring EDS, Oxytocin, Pain, Hypermobile Ehlers-Danlos Syndrome

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1) Premenopausal Females, Age >18 years 2) Clinical diagnosis of hypermobile EDS according to the 2017 criteria for hEDS 3) Menstrual periods (range from 8 to 42 days) 4) 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. 5) On a stable regimen for pain control without any expected increase in dose of pain medications during the study period. 6) All participants should have a negative urine pregnancy test and agree to use an acceptable method of contraception (abstinence or barrier methods).

Exclusion Criteria:

1) Known allergy to OXT or preservatives in the medication 2) Pregnancy 3) Lactation 4) 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 5) History of known cardiac arrhythmias (except for asymptomatic sinus tachycardia and sinus bradycardia) 6) Heart rate persistently greater than 110/min or less than 50 per minute 7) QTC of > 450 ms from EKG (electrocardiogram) test 8) Taking oral or other hormonal contraceptives 9) Individuals with a clinical condition which, in the view of the investigator compromises safety 10) Participating in another interventional study.

Sites / Locations

  • Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Oxytocin

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Change in participant's subjective reported chronic pain
Change in the individual's subjective reported pain following treatment with oxytocin compared to treatment with placebo evaluated by using Brief Pain Inventory.

Secondary Outcome Measures

Change in heart rate patterns
Change in heart rate patterns following treatment with oxytocin compared to treatment with placebo for an objective functional outcome of pain as measured by Actiheart device.
Change in activity level
Change in activity level following treatment with oxytocin compared to treatment with placebo for an objective functional outcome of pain as measured by Actiheart device.
Changes in depression assessment
Change in reported signs of anxiety following treatment with oxytocin compared to treatment with placebo assessed by using the Hospital anxiety and depression scale.
Changes in anxiety assessment
Change in reported signs of anxiety following treatment with oxytocin compared to treatment with placebo assessed by using the State-Trait Anxiety Inventory.

Full Information

First Posted
June 2, 2022
Last Updated
July 26, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05405257
Brief Title
Oxytocin for Hypermobile Ehlers-Danlos Syndrome
Acronym
EDS-OXY
Official Title
Oxytocin Treatment for Chronic Pain in Hypermobile Ehlers-Danlos Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
May 13, 2024 (Anticipated)
Study Completion Date
May 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this pilot study is to evaluate effect of IV oxytocin on chronic pain in patients with Hypermobile Ehlers Danlos syndrome.
Detailed Description
This will be a single-site study to evaluate the effect of IV oxytocin on chronic pain in female adult patients with hypermobile EDS. Oxytocin secretion in the body is dynamic and can be affected by multiple factors including the menstrual period. In order to have minimum variation between tested individuals we conduct this study in females at the same stage of their menstrual cycles. Hypermobile EDS is more prevalent in females and the symptoms are usually more severe in females and more females come to medical attention. We are not aware of any difference in the risk from using oxytocin in females vs males. All participating individuals are affected with hypermobile-EDS (hEDS) with chronic moderate to severe pain. Study will include two periods of treatment - one with placebo and one with oxytocin and a one month period will be held in between the two treatments. Participants will be blinded to the order of treatment. Each period of treatment will start 7-10 days after the beginning of the menstrual cycle and will include 6 days of daily subjective pain evaluation using pain-evaluation questionnaire ('preinfusion evaluation') followed by three consecutive daily infusions (placebo or oxytocin). Response to treatment will be evaluated by questionnaire during 6 days after each three infusion days (placebo or oxytocin) . Additional questionnaires for evaluation of anxiety and depression will be used as well. Patients will be asked to wear ACTIHEART device (measures heart rate, heart rate variation, and activity levels) 3 days prior to infusion, during the 3 days of infusion, and in the 3 days after the last infusion day. For each infusion period, participants will arrive to the study site for three daily consecutive visits, each will last for 3-4 hours. Response variables will be collected prior, during and after each infusion. Patients will fill out pain evaluation questionnaires pre and post infusion and some questionnaires during the days of infusion. Blood pressure and heart rate measurements will be taken prior, during and after the infusion. Blood samples for measurements of oxytocin levels and blood samples for future analysis will be collected in some of the infusion days (before and after the infusion).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermobile Ehlers-Danlos Syndrome, Pain Assessment
Keywords
EDS, Oxytocin, Pain, Hypermobile Ehlers-Danlos Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This will be a single-blind study. This study will include two treatment periods. One for placebo and one for oxytocin. The participants will be blinded to the sequence of treatment assignment.
Masking
Participant
Masking Description
Participant will be blinded to the sequence of treatment assignment. Infusion bags containing either the placebo and drug will not be labeled or known to the participant.
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
Arm Title
Oxytocin
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
IV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
IV, 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
Primary Outcome Measure Information:
Title
Change in participant's subjective reported chronic pain
Description
Change in the individual's subjective reported pain following treatment with oxytocin compared to treatment with placebo evaluated by using Brief Pain Inventory.
Time Frame
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.
Secondary Outcome Measure Information:
Title
Change in heart rate patterns
Description
Change in heart rate patterns following treatment with oxytocin compared to treatment with placebo for an objective functional outcome of pain as measured by Actiheart device.
Time Frame
For each arm we will compare changes in heart rate reported 3 days before infusion, 3 days of infusion, and 3 days post-infusion. This difference will be compared between the two treatment arms.
Title
Change in activity level
Description
Change in activity level following treatment with oxytocin compared to treatment with placebo for an objective functional outcome of pain as measured by Actiheart device.
Time Frame
For each arm we will compare changes in activity levels reported 3 days before infusion, 3 days of infusion, and 3 days post-infusion. This difference will be compared between the two treatment arms.
Title
Changes in depression assessment
Description
Change in reported signs of anxiety following treatment with oxytocin compared to treatment with placebo assessed by using the Hospital anxiety and depression scale.
Time Frame
For each arm we will compare depression 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.
Title
Changes in anxiety assessment
Description
Change in reported signs of anxiety following treatment with oxytocin compared to treatment with placebo assessed by using the State-Trait Anxiety Inventory.
Time Frame
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.
Other Pre-specified Outcome Measures:
Title
Change in participant's pain levels assessed by numerical rating
Description
Change in reported pain following treatment with oxytocin compared to treatment with placebo as assessed by using the Numerical pain rating scale.
Time Frame
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.
Title
Change in participant's pain levels by evaluating pain experience
Description
Change in reported pain following treatment with oxytocin compared to treatment with placebo as assessed by using the McGill Pain Questionnaire.
Time Frame
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Premenopausal Females, Age >18 years 2) Clinical diagnosis of hypermobile EDS according to the 2017 criteria for hEDS 3) Menstrual periods (range from 8 to 42 days) 4) 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. 5) On a stable regimen for pain control without any expected increase in dose of pain medications during the study period. 6) All participants should have a negative urine pregnancy test and agree to use an acceptable method of contraception (abstinence or barrier methods). Exclusion Criteria: 1) Known allergy to OXT or preservatives in the medication 2) Pregnancy 3) Lactation 4) 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 5) History of known cardiac arrhythmias (except for asymptomatic sinus tachycardia and sinus bradycardia) 6) Heart rate persistently greater than 110/min or less than 50 per minute 7) QTC of > 450 ms from EKG (electrocardiogram) test 8) Taking oral or other hormonal contraceptives 9) Individuals with a clinical condition which, in the view of the investigator compromises safety 10) Participating in another interventional study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Tran, BS
Phone
8328224264
Email
alyssat@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Keren Machol, MD, PhD
Phone
8328224280
Email
Keren.Machol@bcm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan Lee, MD, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keren Machol, MD, PhD
Phone
832-822-4680
Email
Keren.Machol@bcm.edu
First Name & Middle Initial & Last Name & Degree
Alyssa Tran, BS
Phone
8328224264
Email
alyssat@bcm.edu
First Name & Middle Initial & Last Name & Degree
Brendan Lee, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oxytocin for Hypermobile Ehlers-Danlos Syndrome

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