Clinical trial

Oxytocin Treatment for Chronic Pain in Hypermobile Ehlers-Danlos Syndrome

Name

H-45648

Description

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

Trial arms

Trial start

2022-05-13

Estimated PCD

2024-05-13

Trial end

2025-05-13

Status

Recruiting

Phase

Early phase I

Treatment

Oxytocin

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

Arms:

Oxytocin

Placebo

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

Arms:

Placebo

Size

Primary endpoint

Change in participant's subjective reported chronic pain

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.

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2023-07-28

1 organization

1 product

2 indications

Organization

Baylor College of Medicine

Product

Oxytocin

Indication

Ehlers-Danlos Syndrome

Indication

Pain Assessment