Post-dural Puncture HeadachePhase 2ESYBRECHENCT02813655
Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
A Phase 2 study testing Tetracosactide (Synacthène®) in people with Post-dural Puncture Headache, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-dural Puncture Headache
- What is being tested?
- Tetracosactide (Synacthène®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2016to 21 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- Age greater than or equal to 18 years
- Affiliation to social security scheme
- Inform Consent signed after oral and written information
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron
Hospices Civils de Lyon / hôpital de la Croix rousse
Lyon, 69004
About this study
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.
- Conditions
- Post-dural Puncture Headache
- Being tested
- Tetracosactide (Synacthène®), placebo saline (0.9% NaCl)
- Keywords
- tetracosactide, Synacthène®, cosyntropin, post-dural syndrom, post-dural puncture headache
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetracosactide (Synacthène®)Drug
Tetracosactide, manufactured by Sigma-Tau® laboratories and marketed under the name of Synacthène®.
All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 1 mg of Synacthène® intravenously during 20 minutes. Four vials of 1 ml of Synacthène® will be added to a bag of 100 ml of physiological saline. The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15.
placebo saline (0.9% NaCl)Drug
placebo saline manufactured by the laboratory Aguettant: 10ml vial, 4 mL will be collected and added to a bag of 100 ml of saline.
All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 4 ml of placebo saline added to a bag of 100 ml of physiological saline ( 104 ml of physiological saline). The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Tetracosactide (Synacthène®) Receives: Drug: Tetracosactide (Synacthène®) |
| Control arm | Placebo comparator | placebo saline (0.9% NaCl) Receives: Drug: placebo saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of blood patch use
Assessment of the rate of blood patch use between experimental group (Synacthène®) and control group between day 0 and day 15.
Measured: Day 15
Secondary outcomes (6)
Side effects
Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15
Measured: Day 15
Duration of headache
Duration of headache in each group (control and experimental) between day 0 and day 15
Measured: Day 15
Intensity of headache
Intensity of headache in each group (control and experimental) between day 0 and day 15
Measured: Day 15
analgesic use (type and duration) in each group (control and experimental)
analgesic use (type and duration) in each group (control and experimental) between day 0 and day 15
Measured: Day 15
blood-patch number
blood-patch number per patient in each group (control and experimental) between day 0 and day 15
Measured: Day 15
Time to first analgesic use after injection of treatment (Synacthène® or placebo)
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2022
- Study completion21 Nov 2022
Why it stopped: Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813655
- Sponsor's protocol ID
- 69HCL15_0429
- Other IDs
- 2015-003357-17, 2015
- Acronym
- ESYBRECHE
- Status last verified
- Aug 2025
- First submitted
- 22 Jun 2016
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dziadzko M, Bouvet L, Steer N, Depaulis C, Pradat P, Joubert F, Lalande L, Chassard D, Aubrun F. No effect of tetracosactide for treatment of postdural puncture headaches in parturient women: a double-blind randomised controlled clinical trial. Br J Anaesth. 2025 Jul;135(1):148-154. doi: 10.1016/j.bja.2025.04.012. Epub 2025 May 19.
PubMed 40393818Depaulis C, Steer N, Garessus L, Chassard D, Aubrun F. 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. Trials. 2020 Jan 8;21(1):55. doi: 10.1186/s13063-019-4015-y.
PubMed 31915040
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
- ClinicalTrials.gov ID
- NCT02813655
- Acronym / sponsor ID
- ESYBRECHE / 69HCL15_0429
- Conditions
- Post-dural Puncture Headache
- Keywords
- tetracosactide, Synacthène®, cosyntropin, post-dural syndrom, post-dural puncture headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05)
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Tetracosactide (Synacthène®)Tetracosactide (Synacthène®) |
| Control arm | Placebo comparator | Drug: placebo saline (0.9% NaCl)placebo saline (0.9% NaCl) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetracosactide (Synacthène®)Tetracosactide, manufactured by Sigma-Tau® laboratories and marketed under the name of Synacthène®. All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 1 mg of Synacthène® intravenously during 20 minutes. Four vials of 1 ml of Synacthène® will be added to a bag of 100 ml of physiological saline. The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15. | Drug | Experimental arm |
| placebo saline (0.9% NaCl)placebo saline manufactured by the laboratory Aguettant: 10ml vial, 4 mL will be collected and added to a bag of 100 ml of saline. All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 4 ml of placebo saline added to a bag of 100 ml of physiological saline ( 104 ml of physiological saline). The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15. | Drug | Control arm |
Primary outcome
Rate of blood patch use
Time frame: Day 15
Assessment of the rate of blood patch use between experimental group (Synacthène®) and control group between day 0 and day 15.
6 secondary outcomes
Side effects
Time frame: Day 15
Duration of headache
Time frame: Day 15
Intensity of headache
Time frame: Day 15
analgesic use (type and duration) in each group (control and experimental)
Time frame: Day 15
blood-patch number
Time frame: Day 15
Time to first analgesic use after injection of treatment (Synacthène® or placebo)
Time frame: Day 15
Results and safety
The study was stopped early (reason given: Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Results publication: PubMed 40393818Dziadzko M, Bouvet L, Steer N, Depaulis C, Pradat P, Joubert F, Lalande L, Chassard D, Aubrun F. No effect of tetracosactide for treatment of postdural puncture headaches in parturient women: a double-blind randomised controlled clinical trial. Br J Anaesth. 2025 Jul;135(1):148-154. doi: 10.1016/j.bja.2025.04.012. Epub 2025 May 19.
- Derived from this study: PubMed 31915040Depaulis C, Steer N, Garessus L, Chassard D, Aubrun F. 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. Trials. 2020 Jan 8;21(1):55. doi: 10.1186/s13063-019-4015-y.
Related trials for Post-dural Puncture Headache
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tetracosactide (Synacthène®) in people with Post-dural Puncture Headache, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of blood patch use (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813655, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.