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New treatment option for Post-Dural Puncture Headache
Official title Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture
ClinicalTrials.gov ID: NCT05116930
What this study is testing
What is Neostigmine?
Neostigmine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for post-dural puncture headache.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate Neostigmine and Glycopyrrolate to treat post-dural puncture headache (PDPH) to reduce the proportion of postpartum women with a PDPH requiring epidural blood patch (EBP) who developed a PDPH after accidental dural puncture.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 54, women only
You may be able to join if
- Post-dural puncture headache (PDPH) after documented dural puncture with Tuohy needle during placement of epidural analgesia for labor and no other...
- Onset of HA within 72 hours of delivery.
You likely can't join if
- Patient refusal.
- Visual analog scale (NRS) score \< 4.
- History of migraine headaches.
- Asthma.
- Arrhythmia.
- Heart block.
See the full eligibility criteria
- Post-dural puncture headache (PDPH) after documented dural puncture with Tuohy needle during placement of epidural analgesia for labor and no other explanation for headache (HA).
- Onset of HA within 72 hours of delivery.
- Patient refusal.
- Visual analog scale (NRS) score \< 4.
- History of migraine headaches.
- Asthma.
- Arrhythmia.
- Heart block.
- Myasthenia gravis.
- Inability to understand pain scores and other questionnaires.
- Inability to speak English.
- Contraindication to acetaminophen or NSAIDs.
- Temperature \> 38.5 C.
- Prior EBP done for this HA.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 54 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.