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Trial · Interventional

TerminatedPhase 2Registry data

Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)

Short name ESYBRECHE

NCTNCT02813655 (opens ClinicalTrials.gov in a new tab)Other id69HCL15_0429Other id2015-003357-17Other id2015
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
46 participants (actual)
Sponsor
Hospices Civils de Lyon · Other
Design
Randomized · Triple masking
Countries
1 country

France

Start
Oct 2016
Primary completion
Nov 2022
Completion
21 Nov 2022
First posted
27 Jun 2016 (estimated)
Last update posted
8 Aug 2025
Conditions
Post-dural Puncture Headache

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201820202022
  1. Ph 2

    ESYBRECHE

    NCT02813655

    Oct 2016 to 21 Nov 2022

    Terminated

Registry summary

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

The aim of the study is to assess the efficacy and safety of Synacthène® versus placebo in the treatment of post-dural puncture syndrome in patients receiving epidural analgesia, spinal analgesia, or combined spinal-epidural analgesia for labour.

Interventions

  • Tetracosactide (Synacthène®)Drug
  • placebo saline (0.9% NaCl)Drug

Arms2

  • Experimental

    Experimental arm

    Tetracosactide (Synacthène®)

  • Placebo comparator

    Control arm

    placebo saline (0.9% NaCl)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Rate of blood patch use

    Time frame · Day 15

    Registry description

    Assessment of the rate of blood patch use between experimental group (Synacthène®) and control group between day 0 and day 15.

Secondary outcomes(6)

  1. Side effects

    Time frame · Day 15

    Registry description

    Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15

  2. Duration of headache

    Time frame · Day 15

    Registry description

    Duration of headache in each group (control and experimental) between day 0 and day 15

  3. Intensity of headache

    Time frame · Day 15

    Registry description

    Intensity of headache in each group (control and experimental) between day 0 and day 15

  4. analgesic use (type and duration) in each group (control and experimental)

    Time frame · Day 15

    Registry description

    analgesic use (type and duration) in each group (control and experimental) between day 0 and day 15

  5. blood-patch number

    Time frame · Day 15

    Registry description

    blood-patch number per patient in each group (control and experimental) between day 0 and day 15

  6. Time to first analgesic use after injection of treatment (Synacthène® or placebo)

    Time frame · Day 15

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

7 results

No effect of tetracosactide for treatment of postdural puncture headaches in parturient women: a double-blind randomised controlled clinical trial.

Dziadzko et al. 2025British journal of anaesthesiacited by 2

PMID 40393818PMC12597418DOI 10.1016/j.bja.2025.04.012PUB-40393818

Rights unknown7 results
Source linkSee results (7)

More studies

1 study on this page

Indexing hint: Clinical trial · 2020

Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial.

Depaulis et al. 2020Trialscited by 1

PMID 31915040PMC6950989DOI 10.1186/s13063-019-4015-yPUB-31915040

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: All women who received epidural, spinal, or combined spinal-epidural labour analgesia and presenting post-dural puncture headache: * Intense: with ≥3 / 10 numerical rating pain scale * Appearing within 5 days after delivery * Aggravating in sitting or standing position and / or improving supine * Can be associated with one of the following criteria: tinnitus, nausea, photophobia, neck stiffness or pain, hearing loss * After exclusion of clinically differential diagnoses (preeclampsia or eclampsia, cerebral venous thrombosis, migraine) * Age greater than or equal to 18 years * Affiliation to social security scheme * Inform Consent signed after oral and written information Exclusion Criteria: * Presence of diplopia (indication of immediate blood patch) * Contraindication to ACTH or Synacthène® (unbalanced hypertension, uncontrolled diabetes, uncontrolled psychosis, infectious viral disease state or evolving) * Processing of Torsade de Pointe provider (astenizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine) * Live vaccine in the months prior to inclusion * Hypersensitivity to Synacthène® * Patient who have previously received Synacthène® after delivery * Contraindication to blood patch (fever or leukocytosis, HIV or HCV patient) * Eclampsia or preeclampsia during this pregnancy * Patient who have received prophylactic blood patch (at diagnosis of Accidental Dural Puncture) * Minor under 18 or protected * Psychological disorders do not allowing informed consent * Refusal of participation in the study or participation in another ongoing interventional study * Withdrawal of consent

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