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

What Was Tested

The trial (phase 2) is built around Cosyntropin.

It had two arms (groups): Experimental arm (experimental) and Control arm (placebo comparator).

Tetracosactide (Synacthène®).

The registry classes the interventions as drug.

Who Took Part

The registry lists 46 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Intense: with ≥3 / 10 numerical rating pain scale. Appearing within 5 days after delivery. 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.

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: 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).

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Cosyntropin and who got the comparison, which limits bias.

The Cosyntropin group and the comparison group ran side by side rather than switching.

As a double-blind Cosyntropin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2016-10 with completion listed for 2022-11.

It ran at 2 sites in France (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Rate of blood patch use (time frame: Day 15).

It also tracked 6 secondary outcomes, for example Side effects, Duration of headache, Intensity of headache, analgesic use (type and duration) in each group (control and experimental), blood-patch number and Time to first analgesic use after injection of treatment (Synacthène® or placebo).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cosyntropin in 46 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cosyntropin compound page, all human trials.