Trial Outcomes & Findings for Oxytocin for Hypermobile Ehlers-Danlos Syndrome (NCT NCT05405257)
NCT ID: NCT05405257
Last Updated: 2025-08-28
Results Overview
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).
TERMINATED
PHASE1/PHASE2
2 participants
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.
2025-08-28
Participant Flow
This is a single blinded study with a fixed sequence. The same subject received the placebo and after a washout of at least 30 days later, the treatment with oxytocin.
Participant milestones
| Measure |
Placebo First Then Oxytocin
1. First intervention (15 days) Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
2. Washout of 30 days
3. Second intervention (15 days) Oxytocin treatment: IV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
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|---|---|
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Overall Study
STARTED
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2
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Placebo First Then Oxytocin
1. First intervention (15 days) Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
2. Washout of 30 days
3. Second intervention (15 days) Oxytocin treatment: IV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Oxytocin for Hypermobile Ehlers-Danlos Syndrome
Baseline characteristics by cohort
| Measure |
Placebo First Then Oxytocin Sequence
n=1 Participants
sequence of Placebo-washout-Oxytocin. Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day) Washout of 30 days 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)
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|---|---|
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Age, Categorical
Between 18 and 65 years
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1 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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1 Participants
n=5 Participants
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|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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1 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.Population: Only one patient completed the sequence
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).
Outcome measures
| Measure |
Placebo-Oxytocine Sequence
n=1 Participants
Sequence of treatment:
Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
Washout of 1 month
Oxytocin: IV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
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|---|---|
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Change in Participant's Subjective Reported Chronic Pain
Mean pain levels pre-placebo (mean of values documented on days 1,3,5 of pre treatment period)
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5.3 score on a scale
Standard Deviation 1.15
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Change in Participant's Subjective Reported Chronic Pain
Mean pain levels post placebo (mean of values documented on days 1,3,5 of post treatment period)
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2 score on a scale
Standard Deviation 1
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Change in Participant's Subjective Reported Chronic Pain
Mean pain levels pre-OXT (mean of values documented on days 1,3,5 of pre treatment period)
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4.3 score on a scale
Standard Deviation 0.58
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Change in Participant's Subjective Reported Chronic Pain
Mean pain levels post OXT (mean of values documented on days 1,3,5 of post treatment period)
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6.7 score on a scale
Standard Deviation 2.5
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PRIMARY outcome
Timeframe: 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)Population: One patient who completed the entire sequence
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)
Outcome measures
| Measure |
Placebo-Oxytocine Sequence
n=1 Participants
Sequence of treatment:
Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
Washout of 1 month
Oxytocin: IV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
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|---|---|
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Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire.
Pain score pre-placebo (value documented on day 1 of pre-infusion period)
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27 score on a scale
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Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire.
Pain score post placebo (value documented on day 1 of post-infusion period)
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13 score on a scale
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Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire.
Pain score pre-OXT (value documented on day 1 of pre-infusion period)
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31 score on a scale
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Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire.
Pain score post OXT (value documented on day 1 of post-infusion period)
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44 score on a scale
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PRIMARY outcome
Timeframe: 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.Population: Only one patient completed the sequence
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).
Outcome measures
| Measure |
Placebo-Oxytocine Sequence
n=1 Participants
Sequence of treatment:
Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
Washout of 1 month
Oxytocin: IV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
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|---|---|
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Change in Participant's Subjective Reported Pain
Mean pain levels pre-placebo (mean of values documented on days 1,3,5 of pre treatment period)
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3.3 score on a scale
Standard Deviation 1.5
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Change in Participant's Subjective Reported Pain
Mean pain levels post placebo (mean of values documented on days 1,3,5 of post treatment period)
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1.3 score on a scale
Standard Deviation 1.5
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Change in Participant's Subjective Reported Pain
Mean pain levels pre-OXT (mean of values documented on days 1,3,5 of pre treatment period)
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2.7 score on a scale
Standard Deviation 1.2
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Change in Participant's Subjective Reported Pain
Mean pain levels post OXT (mean of values documented on days 1,3,5 of post treatment period)
|
1.7 score on a scale
Standard Deviation 1.15
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SECONDARY outcome
Timeframe: 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)Population: One patient who completed the entire sequence
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.
Outcome measures
| Measure |
Placebo-Oxytocine Sequence
n=1 Participants
Sequence of treatment:
Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
Washout of 1 month
Oxytocin: IV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
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|---|---|
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Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
Anxiety score pre-placebo (value documented on day 6 of pre-infusion period)
|
10 score on a scale
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Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
Anxiety score post placebo (value documented on day 6 of post-infusion period)
|
13 score on a scale
|
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Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
Anxiety score pre-OXT (value documented on day 6 of pre-infusion period)
|
12 score on a scale
|
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Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
Anxiety score post OXT (value documented on day 6 of post-infusion period)
|
10 score on a scale
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SECONDARY outcome
Timeframe: 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)Population: One patient who completed the entire sequence
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.
Outcome measures
| Measure |
Placebo-Oxytocine Sequence
n=1 Participants
Sequence of treatment:
Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
Washout of 1 month
Oxytocin: IV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
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|---|---|
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Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
depression score pre-placebo (value documented on day 6 of pre-infusion period)
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0 score on a scale
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Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
depression score post placebo (value documented on day 6 of post-infusion period)
|
4 score on a scale
|
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Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
depression score pre-OXT (value documented on day 6 of pre-infusion period)
|
2 score on a scale
|
|
Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
depression score post OXT (value documented on day 6 of post-infusion period)
|
2 score on a scale
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SECONDARY outcome
Timeframe: 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)Population: One patient who completed the entire sequence
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)
Outcome measures
| Measure |
Placebo-Oxytocine Sequence
n=1 Participants
Sequence of treatment:
Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
Washout of 1 month
Oxytocin: IV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
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|---|---|
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Change Between Pre and Post Treatment Anxiety Scores Using the "State" Part of the State-Trait Anxiety Inventory (STAI) Questionnaire.
Anxiety score pre-placebo (value documented on day 6 of pre-infusion period)
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59 score on a scale
|
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Change Between Pre and Post Treatment Anxiety Scores Using the "State" Part of the State-Trait Anxiety Inventory (STAI) Questionnaire.
Anxiety score post placebo (value documented on day 6 of post-infusion period)
|
44 score on a scale
|
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Change Between Pre and Post Treatment Anxiety Scores Using the "State" Part of the State-Trait Anxiety Inventory (STAI) Questionnaire.
Anxiety score pre-OXT (value documented on day 6 of pre-infusion period)
|
54 score on a scale
|
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Change Between Pre and Post Treatment Anxiety Scores Using the "State" Part of the State-Trait Anxiety Inventory (STAI) Questionnaire.
Anxiety score post OXT (value documented on day 6 of post-infusion period)
|
50 score on a scale
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Adverse Events
Sequence Placebo-oxytocin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place