NCT05116930 Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture
| NCT ID | NCT05116930 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Post-Dural Puncture Headache |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2021-11-19 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 18 participants in total. It began in 2021-11-19 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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.
Contact & Investigator
Mark Rollins, MD, PhD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05116930 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 54 Years, studying Post-Dural Puncture Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05116930 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05116930 currently recruiting?
Yes, NCT05116930 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT05116930 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05116930 clinical trial?
NCT05116930 is sponsored by Mayo Clinic. The principal investigator is Mark Rollins, MD, PhD at Mayo Clinic. The trial plans to enroll 18 participants.