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Anticholinergic

Neostigmine + Atropine for Post-Dural Puncture Headache

Phase 2
Recruiting
Led By Mark Rollins, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if two medications, neostigmine and glycopyrrolate, can help new mothers with severe headaches caused by a spinal puncture during childbirth. The treatment aims to reduce the need for a more invasive procedure. Neostigmine increases brain fluid and tightens blood vessels to relieve pain, while glycopyrrolate reduces side effects.

Who is the study for?
This trial is for postpartum women who developed a headache within 72 hours after delivery, specifically due to an accidental dural puncture during epidural analgesia. It's not suitable for those with asthma, heart issues like block or arrhythmias, inability to understand pain scores or speak English, fever over 38.5 C, refusal to participate, contraindications to certain pain relievers, history of migraines or myasthenia gravis.
What is being tested?
The study tests Neostigmine and Glycopyrrolate as treatments for headaches following dural puncture in new mothers. The goal is to see if these drugs can reduce the need for an epidural blood patch in women who got headaches after the needle used during labor caused a puncture.
What are the potential side effects?
Potential side effects may include dry mouth from Glycopyrrolate and muscle cramps or twitching from Neostigmine. Both drugs could cause changes in heart rate and vision disturbances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of postpartum women requiring epidural blood patch
Secondary study objectives
Adverse Events
Change in pain scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Postpartum dural puncture headache following dural puncture from Tuohy needleExperimental Treatment2 Interventions
Subjects identified as experienced a post dural puncture headache after a confirmed dural puncture from a Tuohy needle will receive an IV administration of the study medications neostigmine and glycopyrrolate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glycopyrrolate
2011
Completed Phase 4
~23980
Neostigmine
2020
Completed Phase 4
~2050

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Neostigmine, an acetylcholinesterase inhibitor, increases acetylcholine levels, enhancing parasympathetic activity and potentially improving cerebrospinal fluid (CSF) production, which can alleviate Post-Dural Puncture Headache (PDPH) symptoms. Glycopyrrolate, an anticholinergic agent, reduces parasympathetic activity, helping to manage symptoms like nausea associated with PDPH. Understanding these mechanisms is crucial for PDPH patients as it highlights the importance of balancing parasympathetic and sympathetic activities to manage headache and associated symptoms effectively.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,329 Previous Clinical Trials
3,059,697 Total Patients Enrolled
1 Trials studying Post-Dural Puncture Headache
Mark Rollins, MD, PhDPrincipal InvestigatorMayo Clinic

Media Library

Atropine (Anticholinergic) Clinical Trial Eligibility Overview. Trial Name: NCT05116930 — Phase 2
Post-Dural Puncture Headache Research Study Groups: Postpartum dural puncture headache following dural puncture from Tuohy needle
Post-Dural Puncture Headache Clinical Trial 2023: Atropine Highlights & Side Effects. Trial Name: NCT05116930 — Phase 2
Atropine (Anticholinergic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05116930 — Phase 2
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