Migraine DisordersPhase 4NCT02314351
Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial
A Phase 4 study testing Metoclopramide 10 mg and Fentanyl in people with Migraine Disorders, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Metoclopramide 10 mg and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2014to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting to the emergency department with migraine attack (with aura or without aura, according to International Headache Society criteria, 2013)
- The patients older than 18 years
- Patients who agree to participate to the study by reading and signing the informed consent document
Who cannot join
- The patients younger than 18 years
- Pregnants
- Patients taking any analgesic drugs last 2 hours
- Documented or declared allergy to metoclopramide
- Patients who are hemodynamically unstable
- Patients who do not agree to participate to the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University, Faculty of Medicine
Köseköy, Kocaeli, 41000
About this study
Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. Those trials suggested that metoclopramide produced larger improvements in visual analog scale (VAS) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.
- Conditions
- Migraine Disorders
- Being tested
- Metoclopramide 10 mg, Placebo, Fentanyl
- Keywords
- migraine disorders, migraine with aura, migraine without aura, pain management, emergency department
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoclopramide 10 mgDrug
Also called Metoclopramide 10 mg (2 mL) in 100 mL normal saline
Intravenous form of metoclopramide is in the same appearance with placebo
PlaceboDrug
Also called 100 mL normal saline
Intravenous form of metoclopramide is in the same appearance with placebo
FentanylDrug
Also called Intravenous fentanyl
Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute
| Study group | Role | What they receive |
|---|---|---|
| Intravenous metoclopramide | Active comparator | Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL) Receives: Drug: Metoclopramide 10 mg; Drug: Placebo; Drug: Fentanyl |
| Placebo | Placebo comparator | 0.9% normal saline solution (total 100 mL) Receives: Drug: Metoclopramide 10 mg; Drug: Placebo; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between pain scores for both drugs
The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups
Measured: 15th and 30th minutes
Secondary outcomes (5)
Nausea and vomiting
Change in nausea/vomiting status of the participants
Measured: 30th minute
Adverse reactions
Number of participants with adverse events
Measured: 30th minute
Need for rescue analgesic
Number of patients needed rescue analgesic at 30th minute
Measured: 30th minute
Change in the headache intensity
Change in the headache intensity
Measured: Between 24th and 72th hours
Duplicative presentation to the emergency department
With telephone call
Measured: Between 24th and 72th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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, Care provider
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurettin Özgür Doğan, Kocaeli University
- Investigators
- Nurettin Özgür Doğan, Assoc. Prof, Principal investigator, Kocaeli University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314351
- Sponsor's protocol ID
- KOU KAEK 2014/315
- Status last verified
- Jan 2017
- First submitted
- 5 Dec 2014
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02314351
- Acronym / sponsor ID
- KOU KAEK 2014/315
- Conditions
- Migraine Disorders
- Keywords
- migraine disorders, migraine with aura, migraine without aura, pain management, emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Dec 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.
Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. Those trials suggested that metoclopramide produced larger improvements in visual analog scale (VAS) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous metoclopramide | Active comparator | Drug: Metoclopramide 10 mg, Drug: Placebo, Drug: FentanylIntravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL) |
| Placebo | Placebo comparator | Drug: Metoclopramide 10 mg, Drug: Placebo, Drug: Fentanyl0.9% normal saline solution (total 100 mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presenting to the emergency department with migraine attack (with aura or without aura, according to International Headache Society criteria, 2013)
- The patients older than 18 years
- Patients who agree to participate to the study by reading and signing the informed consent document
Key exclusion criteria (6 listed)
- The patients younger than 18 years
- Pregnants
- Patients taking any analgesic drugs last 2 hours
- Documented or declared allergy to metoclopramide
- Patients who are hemodynamically unstable
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 |
|---|---|---|
| Metoclopramide 10 mgAlso: Metoclopramide 10 mg (2 mL) in 100 mL normal salineIntravenous form of metoclopramide is in the same appearance with placebo | Drug | Intravenous metoclopramide, Placebo |
| PlaceboAlso: 100 mL normal salineIntravenous form of metoclopramide is in the same appearance with placebo | Drug | Intravenous metoclopramide, Placebo |
| FentanylAlso: Intravenous fentanylIntravenous fentanyl (1 mcg/kg), if pain persists at 30th minute | Drug | Intravenous metoclopramide, Placebo |
Primary outcome
The difference between pain scores for both drugs
Time frame: 15th and 30th minutes
The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups
5 secondary outcomes
Nausea and vomiting
Time frame: 30th minute
Adverse reactions
Time frame: 30th minute
Need for rescue analgesic
Time frame: 30th minute
Change in the headache intensity
Time frame: Between 24th and 72th hours
Duplicative presentation to the emergency department
Time frame: Between 24th and 72th hours
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 4 Jan 2017.
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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.
Nurettin Özgür Doğan, Assoc. Prof principal investigator
Kocaeli University, Faculty 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 Metoclopramide 10 mg and Fentanyl in people with Migraine Disorders, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 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 4 Jan 2017. 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 Turkey (Türkiye). 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. 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?
The difference between pain scores for both drugs (time frame: 15th and 30th minutes). 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 4 Jan 2017.