HeadachePhase 4NCT02747511
IV Haloperidol for the Treatment of Headache in the ED
A Phase 4 study testing Haloperidol in people with Headache and Migraine Disorders, run by Western Michigan University School of Medicine.
Trial summary
Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain scores in patients who present to the emergency department (ED) with a complaint of headache. Read more about this study
- Who is it for?
- Ages 13 to 55 years
- Conditions the study is for
- Headache, Migraine Disorders
- What is being tested?
- Haloperidol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2017
- 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 13 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Emergency Department patients that complain of headache or migraine
- Males and females age 13-55
- English is primary language
Who cannot join
- Abnormal blood pressure (>200/100)
- Sudden rapid onsent (normal to worst pain in minutes)
- Fever
- Trauma
- Any history of masses, strokes, head injury or other causes of abnormal anatomy
- QT greater than 450 ms on EKG
Show all 12Show fewer
- Allergy to Haldon
- Any altered mental status (GCS <15)
- Pregnancy
- Any abnormalities on neurologic exam
- Any clinician concern that would require CT scan of brain
- Any prisoner or ward of state
About this study
Official title: Intravenous Haloperidol for the Treatment of Headache in the Emergency Department
Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain scores in patients who present to the emergency department (ED) with a complaint of headache. A total of 150 patients age 13-55 presenting to the emergency department with headache will be enrolled from October 2015 - October 2016. Patients will be randomized and pain scores and side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will be performed by telephone at 24 hours.
- Conditions
- Headache, Migraine Disorders
- Being tested
- Haloperidol, Placebo
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
PlaceboDrug
Also called 0.9% Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| Haloperidol | Active comparator | Not described Receives: Drug: Haloperidol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
>50% reduction in pain per Visual Analog Scale (VAS)
Measured: 90 minute interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Michigan University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica McCoy, Western Michigan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747511
- Sponsor's protocol ID
- BMH-2015-0811
- Status last verified
- Dec 2017
- First submitted
- 19 Apr 2016
- Last updated
- 12 Dec 2017
- Results posted
- No
Publications
McCoy JJ, Aldy K, Arnall E, Petersen J. Treatment of Headache in the Emergency Department: Haloperidol in the Acute Setting (THE-HA Study): A Randomized Clinical Trial. J Emerg Med. 2020 Jul;59(1):12-20. doi: 10.1016/j.jemermed.2020.04.018. Epub 2020 May 10.
PubMed 32402480
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Haloperidol for the Treatment of Headache in the Emergency Department
- ClinicalTrials.gov ID
- NCT02747511
- Acronym / sponsor ID
- BMH-2015-0811
- Conditions
- Headache, Migraine Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Western Michigan University School of MedicineUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Apr 2016 (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.
Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain scores in patients who present to the emergency department (ED) with a complaint of headache. A total of 150 patients age 13-55 presenting to the emergency department with headache will be enrolled from October 2015 - October 2016. Patients will be randomized and pain scores and side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will be performed by telephone at 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haloperidol | Active comparator | Drug: Haloperidol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Emergency Department patients that complain of headache or migraine
- Males and females age 13-55
- English is primary language
Key exclusion criteria (12 listed)
- Abnormal blood pressure (>200/100)
- Sudden rapid onsent (normal to worst pain in minutes)
- Fever
- Trauma
- Any history of masses, strokes, head injury or other causes of abnormal anatomy
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 |
|---|---|---|
| Haloperidol | Drug | Haloperidol |
| PlaceboAlso: 0.9% Sodium Chloride | Drug | Placebo |
Primary outcome
>50% reduction in pain per Visual Analog Scale (VAS)
Time frame: 90 minute interval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Derived from this study: PubMed 32402480McCoy JJ, Aldy K, Arnall E, Petersen J. Treatment of Headache in the Emergency Department: Haloperidol in the Acute Setting (THE-HA Study): A Randomized Clinical Trial. J Emerg Med. 2020 Jul;59(1):12-20. doi: 10.1016/j.jemermed.2020.04.018. Epub 2020 May 10.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haloperidol in people with Headache and Migraine Disorders, run by Western Michigan University School of Medicine.
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 3 inclusion and 12 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
>50% reduction in pain per Visual Analog Scale (VAS) (time frame: 90 minute interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747511, which also lists 1 linked publication.
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 12 Dec 2017.