Phase 2
N=21
Metoclopramide for Post-Traumatic Headache. A Pilot Study
Post-Traumatic Headache
Bottom Line
View on ClinicalTrials.gov: NCT03056352 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants With Sustained Headache Relief — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Metoclopramide (Drug); Diphenhydramine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Headache Relief |
12 | — |
| SECONDARY Post Concussion Symptoms Assessed by Post-concussive Symptom Scale |
11.4 | — |
| SECONDARY Number of Participants Satisfied With Medication; Assessed by Self-evaluation |
16 | — |
Summary
Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.
Eligibility Criteria
Inclusion Criteria
- Traumatic injury to the head has occurred
- Headache has developed within 7 days of injury to the head
- Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)
- The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
- The plan of the attending emergency physician must include treatment with parenteral metoclopramide.
Exclusion Criteria
- Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.
Data sourced from ClinicalTrials.gov (NCT03056352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.