MigrainePhase 4NCT02389829
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
A Phase 4 study testing Hydromorphone, Prochlorperazine and Diphenhydramine in people with Migraine, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Hydromorphone, Prochlorperazine and Diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Oct 2016
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Migraine headache (International Classification of Headache Disorders 3B criteria)
Who cannot join
- Brain imaging ordered
- Fever
- Objective neurological findings
- Pregnancy/ breast feeding
- Allergy/ contraindication to investigational medication
- History of addiction to opioids, use of methadone, any use of opioids previous 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center--Einstein
The Bronx, New York, 10461
About this study
Official title: Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study
Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to prevent adverse events.
- Conditions
- Migraine
- Being tested
- Hydromorphone, Prochlorperazine, Diphenhydramine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Also called Dilaudid
ProchlorperazineDrug
Also called Compazine
DiphenhydramineDrug
Also called Benadryl
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone | Active comparator | Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Receives: Drug: Hydromorphone |
| Prochlorperazine | Active comparator | Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.
Patients can receive second 10mg dose at 1 hour. Receives: Drug: Prochlorperazine; 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 Assessed by Self-evaluation
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, without use of addition medication. 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: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
Secondary outcomes (3)
Number of Participants Needing Rescue Medication as Assessed by Questionnaire
Data collected by telephone. Patients were asked if they needed additional medication after discharge in order to reduce level of pain. This additional medication is considered rescue medication.
Measured: 48 hours after discharge from Emergency Department
Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
Participants were asked to make evaluation of pain status since discharge. Those achieving headache level "mild" or "none" for 1 hour are considered to achieve short term headache relief.
Measured: 48 hours after discharge from Emergency Department
Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
Participants were asked to evaluate pain status since discharge. Participants who achieved total headache freedom for at least 1 hour are considered to achieve short term headache relief.
Measured: 48 hours after discharge from Emergency Department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionOct 2016
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- 127 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
- Investigators
- Benjamin W Friedman, MD, MS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389829
- Sponsor's protocol ID
- 2014-4325
- Status last verified
- Aug 2018
- First submitted
- 10 Mar 2015
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cohen F, Friedman BW. A randomized study of IV prochlorperazine plus diphenhydramine versus IV hydromorphone for migraine-associated symptoms: A post hoc analysis. Headache. 2021 Sep;61(8):1227-1233. doi: 10.1111/head.14185. Epub 2021 Aug 7.
PubMed 34363617Friedman BW, Irizarry E, Solorzano C, Latev A, Rosa K, Zias E, Vinson DR, Bijur PE, Gallagher EJ. Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine. Neurology. 2017 Nov 14;89(20):2075-2082. doi: 10.1212/WNL.0000000000004642. Epub 2017 Oct 18.
PubMed 29046364
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study
- ClinicalTrials.gov ID
- NCT02389829
- Acronym / sponsor ID
- 2014-4325
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 6 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to prevent adverse events.
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 |
|---|---|---|
| Hydromorphone | Active comparator | Drug: HydromorphoneHydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. |
| Prochlorperazine | Active comparator | Drug: Prochlorperazine, Drug: DiphenhydramineProchlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Migraine headache (International Classification of Headache Disorders 3B criteria)
Key exclusion criteria (6 listed)
- Brain imaging ordered
- Fever
- Objective neurological findings
- Pregnancy/ breast feeding
- Allergy/ contraindication to investigational medication
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 |
|---|---|---|
| HydromorphoneAlso: Dilaudid | Drug | Hydromorphone |
| ProchlorperazineAlso: Compazine | Drug | Prochlorperazine |
| DiphenhydramineAlso: Benadryl | Drug | Prochlorperazine |
Primary outcome
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
Time frame: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
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, without use of addition medication. 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.
3 secondary outcomes
Number of Participants Needing Rescue Medication as Assessed by Questionnaire
Time frame: 48 hours after discharge from Emergency Department
Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
Time frame: 48 hours after discharge from Emergency Department
Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
Time frame: 48 hours after discharge from Emergency Department
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34363617Cohen F, Friedman BW. A randomized study of IV prochlorperazine plus diphenhydramine versus IV hydromorphone for migraine-associated symptoms: A post hoc analysis. Headache. 2021 Sep;61(8):1227-1233. doi: 10.1111/head.14185. Epub 2021 Aug 7.
- Derived from this study: PubMed 29046364Friedman BW, Irizarry E, Solorzano C, Latev A, Rosa K, Zias E, Vinson DR, Bijur PE, Gallagher EJ. Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine. Neurology. 2017 Nov 14;89(20):2075-2082. doi: 10.1212/WNL.0000000000004642. Epub 2017 Oct 18.
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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.
Benjamin W Friedman, MD, MS principal investigator
Albert Einstein College of Medicine
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 Hydromorphone, Prochlorperazine and Diphenhydramine in people with Migraine, 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 1 inclusion and 6 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 Aug 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 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?
Yes. Results are posted in the registry (first posted 6 Jun 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 Assessed by Self-evaluation (time frame: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department). 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 NCT02389829, which also lists 2 linked publications.
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 Aug 2018.