Post-Traumatic HeadachePhase 1/2NCT03056352
Metoclopramide for Post-Traumatic Headache. A Pilot Study
A Phase 1/2 study testing Metoclopramide and Diphenhydramine in people with Post-Traumatic Headache, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Headache
- What is being tested?
- Metoclopramide and Diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 15 Aug 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.
- Conditions
- Post-Traumatic Headache
- Being tested
- Metoclopramide, Diphenhydramine
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Also called Reglan
Intravenous medication drip
DiphenhydramineDrug
Also called Benadryl
Intravenous medication drip
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide | Experimental | Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Receives: Drug: Metoclopramide; Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours thru 48 hours after treatment
Secondary outcomes (2)
Post Concussion Symptoms Assessed by Post-concussive Symptom Scale
The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms.
Measured: 7 days
Number of Participants Satisfied With Medication; Assessed by Self-evaluation
Satisfaction is measured by a positive response to the question "Would you want to receive the same medication during a subsequent visit for post-traumatic headache?"
Measured: 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start1 Mar 2017
- Primary completion20 Jul 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin W. Friedman, MD, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056352
- Sponsor's protocol ID
- 2017-7511
- Status last verified
- Jul 2018
- First submitted
- 14 Feb 2017
- Last updated
- 31 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metoclopramide for Post-Traumatic Headache. A Pilot Study
- ClinicalTrials.gov ID
- NCT03056352
- Acronym / sponsor ID
- 2017-7511
- Conditions
- Post-Traumatic Headache
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Posted 31 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide | Experimental | Drug: Metoclopramide, Drug: DiphenhydramineMetoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoclopramideAlso: ReglanIntravenous medication drip | Drug | Metoclopramide |
| DiphenhydramineAlso: BenadrylIntravenous medication drip | Drug | Metoclopramide |
Primary outcome
Number of Participants With Sustained Headache Relief
Time frame: 2 hours thru 48 hours after treatment
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 secondary outcomes
Post Concussion Symptoms Assessed by Post-concussive Symptom Scale
Time frame: 7 days
Number of Participants Satisfied With Medication; Assessed by Self-evaluation
Time frame: 48 hours after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Metoclopramide and Diphenhydramine in people with Post-Traumatic Headache, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Sustained Headache Relief (time frame: 2 hours thru 48 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.