A Phase 4 interventional study of Mirtazapine and Sumatriptan in Headache, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
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.
125 studies on the registry are indexed under Post-Dural Puncture Headache; 25 are open to participants now.
This study's enrollment of 210 is above the median of 80 across 82 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Mirtazapine
Drug: Sumatriptan
Other: Placebo
Mirtazapine 30 mg tablet once daily for 3 successive days
Sumatriptan 50 mg tablet once daily for 3 successive days
Placebo tablets once daily for 3 successive days.
Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours
Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours after intervention (Day 0)
Time frame: 72 hours after intervention (Day 0)
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ain Shams University