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Trial · Interventional

TerminatedPhase 1/2Results postedRegistry data

Oxytocin for Hypermobile Ehlers-Danlos Syndrome

Short name EDS-OXY

NCTNCT05405257 (opens ClinicalTrials.gov in a new tab)Other idH-45648
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 1/2
Enrollment
2 participants (actual)
Sponsor
Baylor College of Medicine · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
13 May 2022
Primary completion
11 Mar 2025
Completion
11 Mar 2025
First posted
6 Jun 2022
Last update posted
28 Aug 2025
Conditions
Hypermobile Ehlers-Danlos Syndrome · Pain Assessment

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023202420252026
  1. Ph 1/2

    EDS-OXY

    NCT05405257

    13 May 2022 to 11 Mar 2025

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this pilot study is to evaluate effect of IV oxytocin on chronic pain in patients with Hypermobile Ehlers Danlos syndrome.

Interventions

  • OxytocinDrug
  • PlaceboOther

Arms1

  • Experimental

    Placebo-Oxytocin sequence

    In this single blind fixed sequence study participants were treated with Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes once a day for three consecutive days (one per day) and a after a washout of at least a month 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)

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Change in Participant's Subjective Reported Chronic Pain

    Time frame · Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated.

    Registry description

    Study evaluated maximum pain level by using the Brief Pain Inventory (BPI). Scale range from minimum value of 1 to maximum value of 10. Higher score indicated more pain (worse outcome).

  2. Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire.

    Time frame · Once prior to treatment with placebo OR oxytocin (day 1 of pre-infusion period / 6 days prior to the infusion) and once after treatment with placebo OR oxytocin (day 1 of post-infusion period / 1 day after the infusion)

    Registry description

    Change in the individual's subjective reported pain following treatment with placebo compared to the change in reported pain following treatment with oxytocin as assessed by McGill Pain Questionnaire. The McGill questionnaire is a self-report measure that explores both the quality and intensity of pain. Minimum score: is 0 (no pain) and maximum score is 78 (severe pain). Higher score indicates higher level of pain (worse outcome)

  3. Change in Participant's Subjective Reported Pain

    Time frame · Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated.

    Registry description

    Study evaluated maximum pain level by using the Numerical pain rating scale. Scale range from minimum value of 1 to maximum value of 10. Higher score indicated more pain (worse outcome).

Secondary outcomes(3)

  1. Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire.

    Time frame · Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)

    Registry description

    Change in the individual's anxiety following treatment with placebo compared to the change in reported anxiety following treatment with oxytocin as assessed by Hospital anxiety and depression scale The Hospital anxiety and depression scale is a self-report measure to evaluate anxiety and depression. Minimum score is 0 and maximum score is 21. Higher score indicates higher level of anxiety (worse outcome) 0-7: Normal or no anxiety/depression. 8-10: Mild anxiety/depression. 11-14: Moderate anxiety/depression. 15-21: Severe anxiety/depression.

  2. Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire.

    Time frame · Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)

    Registry description

    Change in the individual's depression following treatment with placebo compared to the change in reported depression following treatment with oxytocin as assessed by Hospital anxiety and depression scale The Hospital anxiety and depression scale is a self-report measure to evaluate anxiety and depression. Minimum score is 0, maximum score is 21. Higher score indicates higher level of depression (worse outcome) 0-7: Normal or no anxiety/depression. 8-10: Mild anxiety/depression. 11-14: Moderate anxiety/depression. 15-21: Severe anxiety/depression.

  3. Change Between Pre and Post Treatment Anxiety Scores Using the "State" Part of the State-Trait Anxiety Inventory (STAI) Questionnaire.

    Time frame · Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)

    Registry description

    Change in the individual's anxiety following treatment with placebo compared to the change in reported anxiety following treatment with oxytocin as assessed by the "state" part of the State-Trait Anxiety Inventory (STAI) questionnaire. The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety. Minimum score is 20 to maximum score is 80. Higher score indicates higher level of anxiety (worse outcome)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated.

Change in Participant's Subjective Reported Chronic Pain

GroupValue (score on a scale)Spread
Placebo-Oxytocine Sequence5.31.15
Primary outcomeNumber· Once prior to treatment with placebo OR oxytocin (day 1 of pre-infusion period / 6 days prior to the infusion) and once after treatment with placebo OR oxytocin (day 1 of post-infusion period / 1 day after the infusion)

Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire.

GroupValue (score on a scale)
Placebo-Oxytocin Sequence27
Primary outcomeMean· Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated.

Change in Participant's Subjective Reported Pain

GroupValue (score on a scale)Spread
Placebo-Oxytocine Sequence3.31.5
Secondary and other outcome results(3)
Secondary outcomeNumber· Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)

Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire.

GroupValue (score on a scale)
Placebo-Oxytocin Sequence10
Secondary outcomeNumber· Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)

Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire.

GroupValue (score on a scale)
Placebo-Oxytocin Sequence0
Secondary outcomeNumber· Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)

Change Between Pre and Post Treatment Anxiety Scores Using the "State" Part of the State-Trait Anxiety Inventory (STAI) Questionnaire.

GroupValue (score on a scale)
Placebo-Oxytocin Sequence59

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Sequence Placebo-oxytocinPlacebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day) One month of washout 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) Note: the placebo and the treatment were not defined as separated arms as the same individual received both placebo and after a washout - oxytocin. The decision for this study design was done due to expected low recruitment rate.0 / 20 / 20 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 64 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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