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NCT05108688
Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache
Phase 4 trial testing Mirtazapine in Headache in 210 participants. Completed in 20 December 2023.
20 December 2023
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 210 |
| Start date | 15 November 2021 |
| Primary completion | 20 December 2023 |
| Estimated completion | 20 December 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Mirtazapine — full drug profile →
- Sumatriptan (SUMATRIPTAN) — full drug profile →
- Placebo
Conditions studied
- Headache — all drugs for Headache →
Sponsor
Ain Shams University
Who can join
Adults 18 to 40, female only, with Headache. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Postdural puncture headache (PDPH) is a potential complication after spinal anesthesia caused by traction on pain-sensitive structures from low cerebrospinal fluid pressure (intracranial hypotension) following a leak of cerebrospinal fluid at the puncture site. Symptoms of this condition include a bilateral frontal or occipital headache that is worse in the upright position, along with nausea, neck pain, dizziness, visual changes, tinnitus, hearing loss, or radicular symptoms in the arms. This study will examine the efficacy of mirtazapine in in the treatment of PDPH after obstetric surgery under spinal anesthesia and compared its efficacy with that of sumatriptan.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05108688
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Headache
Currently open trials in the same condition.
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Other Ain Shams University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05108688 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 22 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05108688.
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