Migraine HeadachesPhase 4NCT02098499
Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT
A Phase 4 study testing Haloperidol, Metoclopramide 10mg and Diphenhydramine in people with Migraine Headaches and Nausea, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial summary
Haloperidol is known to be a safe alternative medication to control difficult pain, and has been shown effective when compared to placebo for controlling headaches. Investigators hypothesized that the combination of haloperidol and diphenhydramine would be a useful medication choice for migraine headache patients in… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Headaches, Nausea, Restlessness
- What is being tested?
- Haloperidol, Metoclopramide 10mg and Diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2013to 11 Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Migraine Headache must contain the following:
- At least two: Unilateral, Throbbing, Worsening with activity, Moderate to severe pain
- At least one: Nausea or Vomiting, Photophobia or phonophobia
- Ages 18-50
Who cannot join
- Hypersensitivity to haloperidol, metoclopramide, and/or diphenydramine
- History of ischemic heart disease or signs or symptoms of ischemic heart disease
- History of stroke or transient ischemic attack (TIA)
- History of peripheral vascular disease
- History of uncontrolled hypertension with presenting diastolic blood pressure > 100
- Use of an ergotamine derivatives, triptan, or dopamine-blocking anti-emetic within the past 24 hrs
Show all 15Show fewer
- Concurrent administration or within 2 weeks of discontinuing an MAO inhibitor
- Concurrent management of hemiplegic or basilar migraine or known neurologic disorder
- Severe hepatic impairment
- Pregnancy or breastfeeding
- History of cancer (except non-melanoma skin cancer)
- Previous involvement in the study
- Febrile to 100.5 or greater
- Any indication for further diagnostic evaluation of this headache such as a lumbar puncture or CT scan.
- Headache differs from their normal headache
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
Haloperidol is known to be a safe alternative medication to control difficult pain, and has been shown effective when compared to placebo for controlling headaches. Investigators hypothesized that the combination of haloperidol and diphenhydramine would be a useful medication choice for migraine headache patients in the emergency department in comparison to a common migraine treatment regimen of metoclopramide and diphenhydramine.
Read the detailed description
Investigators conducted a prospective, double-blind, randomized controlled trial in migraine patients who presented to an academic emergency department between June 2013 and November 2013. Research data was derived from an IRB approved protocol. All subjects met IHS migraine criteria and received a one liter bolus of normal saline plus 25 milligrams (mg) of diphenhydramine. Subjects were subsequently randomized to receive 10 mg metoclopramide or 5 mg haloperidol IV. Pain was self-reported at onset and at 20 minute intervals using a 100mm visual analog scale (VAS). Adequate pain control was considered to be patient satisfaction with symptomatic relief. If adequate pain relief was not obtained after 80 minutes, rescue medication was given at the treating physician's discretion. Adverse reactions were recorded and electrocardiograms (ECGs) were obtained before and after study medication administration. Follow up phone surveys were performed 72 hours after discharge to assess headache recurrence, adverse effects, and patient satisfaction.
- Conditions
- Migraine Headaches, Nausea, Restlessness
- Being tested
- Haloperidol, Metoclopramide 10mg, Diphenhydramine
- Medical subject headings
- Migraine Disorders, Nausea, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
Also called Haldol
5mg IV
Metoclopramide 10mgDrug
Also called Reglan
10mg IV
DiphenhydramineDrug
Also called Benadryl
25mg IV
| Study group | Role | What they receive |
|---|---|---|
| Haloperidol and Diphenhydramine | Active comparator | Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1 Receives: Drug: Haloperidol; Drug: Diphenhydramine |
| Metoclopramide and Diphenhydramine | Active comparator | Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1 Receives: Drug: Metoclopramide 10mg; Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on the visual analog scale
Measured: 20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark
Secondary outcomes (1)
Nausea and restlessness scores on the visual analog scales
Measured: 20, 40, 60, and 80 minutes s/p administration of medications, and again 48-72 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study start12 Jun 2013
- Primary completion11 Feb 2015
- Study completion11 Feb 2015
Why it stopped: No recruitment occurred and PI retired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadachesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew Gaffigan, MD, Principal investigator, United States Naval Medical Center, Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098499
- Sponsor's protocol ID
- NMCP.2012.0008
- Status last verified
- Jul 2025
- First submitted
- 17 Mar 2014
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT
- ClinicalTrials.gov ID
- NCT02098499
- Acronym / sponsor ID
- NMCP.2012.0008
- Conditions
- Migraine Headaches, Nausea, Restlessness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment occurred and PI retired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- 12 Jun 2013 (actual)
- Primary completion
- 11 Feb 2015 (actual)
- Study completion
- 11 Feb 2015 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Haloperidol is known to be a safe alternative medication to control difficult pain, and has been shown effective when compared to placebo for controlling headaches. Investigators hypothesized that the combination of haloperidol and diphenhydramine would be a useful medication choice for migraine headache patients in the emergency department in comparison to a common migraine treatment regimen of metoclopramide and diphenhydramine.
Detailed description
Investigators conducted a prospective, double-blind, randomized controlled trial in migraine patients who presented to an academic emergency department between June 2013 and November 2013. Research data was derived from an IRB approved protocol. All subjects met IHS migraine criteria and received a one liter bolus of normal saline plus 25 milligrams (mg) of diphenhydramine. Subjects were subsequently randomized to receive 10 mg metoclopramide or 5 mg haloperidol IV. Pain was self-reported at onset and at 20 minute intervals using a 100mm visual analog scale (VAS). Adequate pain control was considered to be patient satisfaction with symptomatic relief. If adequate pain relief was not obtained after 80 minutes, rescue medication was given at the treating physician's discretion. Adverse reactions were recorded and electrocardiograms (ECGs) were obtained before and after study medication administration. Follow up phone surveys were performed 72 hours after discharge to assess headache recurrence, adverse effects, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haloperidol and Diphenhydramine | Active comparator | Drug: Haloperidol, Drug: DiphenhydramineHaloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1 |
| Metoclopramide and Diphenhydramine | Active comparator | Drug: Metoclopramide 10mg, Drug: DiphenhydramineMetoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At least two: Unilateral, Throbbing, Worsening with activity, Moderate to severe pain
- At least one: Nausea or Vomiting, Photophobia or phonophobia
- Ages 18-50
Key exclusion criteria (15 listed)
- Hypersensitivity to haloperidol, metoclopramide, and/or diphenydramine
- History of ischemic heart disease or signs or symptoms of ischemic heart disease
- History of stroke or transient ischemic attack (TIA)
- History of peripheral vascular disease
- History of uncontrolled hypertension with presenting diastolic blood pressure > 100
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 |
|---|---|---|
| HaloperidolAlso: Haldol5mg IV | Drug | Haloperidol and Diphenhydramine |
| Metoclopramide 10mgAlso: Reglan10mg IV | Drug | Metoclopramide and Diphenhydramine |
| DiphenhydramineAlso: Benadryl25mg IV | Drug | Haloperidol and Diphenhydramine, Metoclopramide and Diphenhydramine |
Primary outcome
Pain scores on the visual analog scale
Time frame: 20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark
1 secondary outcome
Nausea and restlessness scores on the visual analog scales
Time frame: 20, 40, 60, and 80 minutes s/p administration of medications, and again 48-72 hours later
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
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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.
Matthew Gaffigan, MD principal investigator
United States Naval Medical Center, Portsmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haloperidol, Metoclopramide 10mg and Diphenhydramine in people with Migraine Headaches and Nausea, run by United States Naval Medical Center, Portsmouth 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 4 inclusion and 15 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: withdrawn, as of the sponsor's last update on 29 Jul 2025. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain scores on the visual analog scale (time frame: 20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark). 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 29 Jul 2025.