Acute Migraine HeadacheNCT00573599
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department
A study testing prochlorperazine and benadryl IV and Imitrex SubQ, saline IV in people with Acute Migraine Headache, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial summary
ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Migraine Headache
- What is being tested?
- prochlorperazine and benadryl IV and Imitrex SubQ, saline IV
- 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
- Feb 2007to May 2007
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Acute migraine headache
Who cannot join
- Pregnant
- Hypertension
- Chest pain
- < 18
- Allergy to any of the meds
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups.
- Conditions
- Acute Migraine Headache
- Being tested
- prochlorperazine and benadryl IV, Imitrex SubQ, saline IV
- Keywords
- Migraine, Emergency, imitrex, prochlorperazine, Acute Migraine Headache in the Emergency Department
- Medical subject headings
- Migraine Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prochlorperazine and benadryl IVDrug
prochlorperazine and benadryl IV, saline subQ
Imitrex SubQ, saline IVDrug
Imitrex SubQ, saline IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | prochlorperazine and benadryl IV, saline subQ Receives: Drug: prochlorperazine and benadryl IV |
| 2 | Active comparator | imitrex SubQ, saline IV Receives: Drug: Imitrex SubQ, saline IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain measured by VAS
Measured: 80 min
Secondary outcomes (1)
Degree of sedation, nausea, akathisia
Measured: 80 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Migraine 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Frank Gutierrez, MD, Principal investigator, US Navy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573599
- Sponsor's protocol ID
- P06-050
- Status last verified
- Aug 2025
- First submitted
- 13 Dec 2007
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department
- ClinicalTrials.gov ID
- NCT00573599
- Acronym / sponsor ID
- P06-050
- Conditions
- Acute Migraine Headache
- Keywords
- Migraine, Emergency, imitrex, prochlorperazine, Acute Migraine Headache in the Emergency Department
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- Feb 2007 (actual)
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 14 Dec 2007 (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.
ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: prochlorperazine and benadryl IVprochlorperazine and benadryl IV, saline subQ |
| 2 | Active comparator | Drug: Imitrex SubQ, saline IVimitrex SubQ, saline IV |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Acute migraine headache
Key exclusion criteria (5 listed)
- Pregnant
- Hypertension
- Chest pain
- < 18
- Allergy to any of the meds
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 |
|---|---|---|
| prochlorperazine and benadryl IVprochlorperazine and benadryl IV, saline subQ | Drug | 1 |
| Imitrex SubQ, saline IVImitrex SubQ, saline IV | Drug | 2 |
Primary outcome
Difference in pain measured by VAS
Time frame: 80 min
1 secondary outcome
Degree of sedation, nausea, akathisia
Time frame: 80 min
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 19 Aug 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.
Frank Gutierrez, MD principal investigator
US Navy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prochlorperazine and benadryl IV and Imitrex SubQ, saline IV in people with Acute Migraine Headache, 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 1 inclusion and 5 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 19 Aug 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.
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?
Difference in pain measured by VAS (time frame: 80 min). 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 19 Aug 2025.