Metoclopramide for Post-Traumatic Headache. A Pilot Study
1 other identifier
interventional
21
1 country
1
Brief Summary
Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2017
CompletedResults Posted
Study results publicly available
July 31, 2018
CompletedJuly 31, 2018
July 1, 2018
5 months
February 14, 2017
May 8, 2018
July 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Sustained Headache Relief
Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration.
2 hours thru 48 hours after treatment
Secondary Outcomes (2)
Post Concussion Symptoms Assessed by Post-concussive Symptom Scale
7 days
Number of Participants Satisfied With Medication; Assessed by Self-evaluation
48 hours after treatment
Study Arms (1)
Metoclopramide
EXPERIMENTALMetoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Benjamin W. Friedman, MD
- Organization
- Montefiore Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 14, 2017
First Posted
February 17, 2017
Study Start
March 1, 2017
Primary Completion
July 20, 2017
Study Completion
August 15, 2017
Last Updated
July 31, 2018
Results First Posted
July 31, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share