NCT05405257: EDS-OXY

Oxytocin for Hypermobile Ehlers-Danlos Syndrome

Terminated Phase 1, PHASE2 Results posted Last updated 28 August 2025

What this trial tests

Phase 1, PHASE2 trial testing Oxytocin in Hypermobile Ehlers-Danlos Syndrome in 2 participants. Terminated before completion.

Timeline

13 May 2022

Primary endpoint
11 March 2025

11 March 2025

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	13 May 2022
Primary completion	11 March 2025
Estimated completion	11 March 2025
Sites	1 location across United States

Drugs / interventions tested

• Oxytocin (OXYTOCIN) — full drug profile →
• Placebo

Conditions studied

• Hypermobile Ehlers-Danlos Syndrome — all drugs for Hypermobile Ehlers-Danlos Syndrome →
• Pain Assessment — all drugs for Pain Assessment →

Sponsor

Baylor College of Medicine

Who can join

Adults 18 to 64, female only, with Hypermobile Ehlers-Danlos Syndrome or Pain Assessment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Participant's Subjective Reported Chronic Pain Primary · 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.

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).

Mean pain levels pre-placebo (mean of values documented on days 1,3,5 of pre treatment period)

Group	Value	95% CI
Placebo-Oxytocine Sequence	5.3	± 1.15

Mean pain levels post placebo (mean of values documented on days 1,3,5 of post treatment period)

Group	Value	95% CI
Placebo-Oxytocine Sequence	2	± 1

Mean pain levels pre-OXT (mean of values documented on days 1,3,5 of pre treatment period)

Group	Value	95% CI
Placebo-Oxytocine Sequence	4.3	± 0.58

Mean pain levels post OXT (mean of values documented on days 1,3,5 of post treatment period)

Group	Value	95% CI
Placebo-Oxytocine Sequence	6.7	± 2.5

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

Pain score pre-placebo (value documented on day 1 of pre-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	27

Pain score post placebo (value documented on day 1 of post-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	13

Pain score pre-OXT (value documented on day 1 of pre-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	31

Pain score post OXT (value documented on day 1 of post-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	44

Change in Participant's Subjective Reported Pain Primary · 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.

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).

Mean pain levels pre-placebo (mean of values documented on days 1,3,5 of pre treatment period)

Group	Value	95% CI
Placebo-Oxytocine Sequence	3.3	± 1.5

Mean pain levels post placebo (mean of values documented on days 1,3,5 of post treatment period)

Group	Value	95% CI
Placebo-Oxytocine Sequence	1.3	± 1.5

Mean pain levels pre-OXT (mean of values documented on days 1,3,5 of pre treatment period)

Group	Value	95% CI
Placebo-Oxytocine Sequence	2.7	± 1.2

Mean pain levels post OXT (mean of values documented on days 1,3,5 of post treatment period)

Group	Value	95% CI
Placebo-Oxytocine Sequence	1.7	± 1.15

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

Anxiety score pre-placebo (value documented on day 6 of pre-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	10

Anxiety score post placebo (value documented on day 6 of post-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	13

Anxiety score pre-OXT (value documented on day 6 of pre-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	12

Anxiety score post OXT (value documented on day 6 of post-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	10

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

depression score pre-placebo (value documented on day 6 of pre-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	0

depression score post placebo (value documented on day 6 of post-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	4

depression score pre-OXT (value documented on day 6 of pre-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	2

depression score post OXT (value documented on day 6 of post-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	2

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

Anxiety score pre-placebo (value documented on day 6 of pre-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	59

Anxiety score post placebo (value documented on day 6 of post-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	44

Anxiety score pre-OXT (value documented on day 6 of pre-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	54

Anxiety score post OXT (value documented on day 6 of post-infusion period)

Group	Value	95% CI
Placebo-Oxytocin Sequence	50

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.