Migraine HeadachePhase 4NCT00915473
Greater Occipital Nerve Block for Migraine Prophylaxis
A Phase 4 study testing bupivicaine, normal saline and methylprednisolone in people with Migraine Headache, run by Mayo Clinic at 1 site in United States.
Trial summary
Migraine is a common neurological condition that can be disabling, particularly if chronic. Greater occipital nerve (GON) block has been utilized for decades for the treatment of migraine in the absence of a single randomized, placebo-controlled trial documenting its effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- bupivicaine, normal saline and methylprednisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jan 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meet diagnostic criteria for episodic migraine or chronic migraine according to the International Headache Classification II (ICHD-II)
- Migraine sufferers who experience at least 1 attack per week
- Able to read and understand the requirements of the study, abide by any restrictions, and return for the required examinations
- Able and willing to sign an informed consent statement
- Subjects must be in generally good health as confirmed by medical history, medication review, baseline physical examination, vital signs and clinical laboratory evaluations.
Who cannot join
- Subjects with continuous headache (no headache free periods)
- Subjects using maintenance opioid medication
- Subjects who have started a medication with prophylactic migraine efficacy within the past 2 months
- Known hypersensitivity or allergic reaction to any of study ingredients (lidocaine, bupivicaine, any local anesthetics, and corticosteroids) or betadine.
- Use of any investigational medication within 90 days of the initial screening visit and/or concurrent enrolment in an investigational study
- Injection site infection or systemic infection at the injection visit (afebrile at time of injection)
Show all 13Show fewer
- Presence of cranial bone defect
- Subjects with chronic cluster headache, new daily persistent headache, hemicrania continua, or chronic tension type headache
- Subjects with a history of an unstable medical condition (e.g. cardiovascular, hepatic, renal, endocrine) that may impair their reliable participation in the study or necessitate the use of medications not permitted in this study
- Subjects with a history (within the past 6 months) of a major psychiatric disorder that in the opinion of the investigator may preclude the subject from completed the requirements of the study
- Female subjects who are pregnant or nursing
- Subjects with a history of drug or alcohol abuse within the past 2 years
- Subjects with a history of poor compliance with past drug therapies, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Migraine is a common neurological condition that can be disabling, particularly if chronic. Greater occipital nerve (GON) block has been utilized for decades for the treatment of migraine in the absence of a single randomized, placebo-controlled trial documenting its effectiveness.
Hypothesis: Greater occipital nerve block reduces the frequency of days with moderate or severe headache in patients with episodic or chronic migraine.
Read the detailed description
Migraine is a common disease with lifetime prevalence in women and men of 33% and 12% respectively. Chronic migraine affects 2% of the US population and is highly disabling. There are no FDA approved medications for the treatment of chronic migraine.
Although some patients benefit from a daily prophylactic medication, others continue to suffer from severe, frequent, debilitating headaches. Limited efficacy, poor compliance, side effects and drug-drug interactions may explain why more than 80% of migraineurs in the population are not prescribed daily prophylactic medications.
Occipital nerve injections with corticosteroids and/or local anesthetics have been employed for the acute and prophylactic treatment of migraine, cervicogenic headache and cluster headache for decades. A long-acting anesthetic and corticosteroid are often combined, although anesthetic agents have also been used alone. However, there are no randomized controlled trials evaluating the preventive efficacy of occipital nerve block in subjects with migraine.
Patients were equally randomized to receive either 2.5 ml 0.5% bupivacaine plus 0.5 ml 20 mg methylprednisolone over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve or 2.75 ml normal saline plus 0.25 ml 1% lidocaine without epinephrine (placebo). The GON injection site was at the medial third of the distance between the occipital protuberance and the mastoid process. Patients were evaluated after the 4-week baseline diary completion phase to undergo the injection, and for 4 weeks after the injection. Therefore, there were 3 patient visits in this study: screening, injection and 4-week follow-up. In an effort to ensure adequate blinding, 0.25 ml of short-acting 1% lidocaine without epinephrine was used as the placebo arm. In order to ensure adequate blinding of the investigator, each syringe and needle hub was covered with opaque tape so as to ensure blinding of the investigator providing the injection. A total of four investigators provided injections. The blinded investigator who evaluated the study subject 4 weeks after injection may or may not be the same as the investigator who provided the injection.
- Conditions
- Migraine Headache
- Being tested
- bupivicaine, normal saline, methylprednisolone, lidocaine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivicaineDrug
Also called Marcain, Marcaine, Sensorcaine, Vivacaine
2.5 mL 0.5% bupivicaine
normal salineDrug
2.75 mL normal saline
Also called Medrol, Solu-Medrol
0.5 mL 20 mg methylprednisolone
lidocaineDrug
Also called xylocaine
0.25 mL 1% lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Active Injection | Experimental | Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve. Receives: Drug: bupivicaine; Drug: methylprednisolone |
| Placebo Injection | Placebo comparator | Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve. Receives: Drug: normal saline; Drug: lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period
The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.
Measured: 4 weeks pre-injection baseline, 4 weeks post-injection
Secondary outcomes (3)
Mean Frequency of Days With a Migraine
Measured: 4 weeks post-injection
Mean Number of Hours With Moderate or Severe Migraine
Measured: 4 weeks post-injection
Mean Number of Days With Acute Medication Use
Acute medication use meant "the consumption of a drug to abort or terminate a headache."
Measured: 4 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2013
- Study completionJan 2013
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 (1)Papers the sponsor has linked to this study.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Investigators
- David W. Dodick, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915473
- Sponsor's protocol ID
- 08-008203
- Other IDs
- UL1TR000135
- Status last verified
- Feb 2014
- First submitted
- 5 Jun 2009
- Last updated
- 20 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dilli E, Halker R, Vargas B, Hentz J, Radam T, Rogers R, Dodick D. Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study. Cephalalgia. 2015 Oct;35(11):959-68. doi: 10.1177/0333102414561872. Epub 2014 Dec 12.
PubMed 25505035
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Greater Occipital Nerve Block for Migraine Prophylaxis
- ClinicalTrials.gov ID
- NCT00915473
- Acronym / sponsor ID
- 08-008203
- Conditions
- Migraine Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- Jun 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Posted 25 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Migraine is a common neurological condition that can be disabling, particularly if chronic. Greater occipital nerve (GON) block has been utilized for decades for the treatment of migraine in the absence of a single randomized, placebo-controlled trial documenting its effectiveness.
Hypothesis: Greater occipital nerve block reduces the frequency of days with moderate or severe headache in patients with episodic or chronic migraine.
Detailed description
Migraine is a common disease with lifetime prevalence in women and men of 33% and 12% respectively. Chronic migraine affects 2% of the US population and is highly disabling. There are no FDA approved medications for the treatment of chronic migraine.
Although some patients benefit from a daily prophylactic medication, others continue to suffer from severe, frequent, debilitating headaches. Limited efficacy, poor compliance, side effects and drug-drug interactions may explain why more than 80% of migraineurs in the population are not prescribed daily prophylactic medications.
Occipital nerve injections with corticosteroids and/or local anesthetics have been employed for the acute and prophylactic treatment of migraine, cervicogenic headache and cluster headache for decades. A long-acting anesthetic and corticosteroid are often combined, although anesthetic agents have also been used alone. However, there are no randomized controlled trials evaluating the preventive efficacy of occipital nerve block in subjects with migraine.
Patients were equally randomized to receive either 2.5 ml 0.5% bupivacaine plus 0.5 ml 20 mg methylprednisolone over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve or 2.75 ml normal saline plus 0.25 ml 1% lidocaine without epinephrine (placebo). The GON injection site was at the medial third of the distance between the occipital protuberance and the mastoid process. Patients were evaluated after the 4-week baseline diary completion phase to undergo the injection, and for 4 weeks after the injection. Therefore, there were 3 patient visits in this study: screening, injection and 4-week follow-up. In an effort to ensure adequate blinding, 0.25 ml of short-acting 1% lidocaine without epinephrine was used as the placebo arm. In order to ensure adequate blinding of the investigator, each syringe and needle hub was covered with opaque tape so as to ensure blinding of the investigator providing the injection. A total of four investigators provided injections. The blinded investigator who evaluated the study subject 4 weeks after injection may or may not be the same as the investigator who provided the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Injection | Experimental | Drug: bupivicaine, Drug: methylprednisoloneSubjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve. |
| Placebo Injection | Placebo comparator | Drug: normal saline, Drug: lidocaineSubjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects meet diagnostic criteria for episodic migraine or chronic migraine according to the International Headache Classification II (ICHD-II)
- Migraine sufferers who experience at least 1 attack per week
- Able to read and understand the requirements of the study, abide by any restrictions, and return for the required examinations
- Able and willing to sign an informed consent statement
- Subjects must be in generally good health as confirmed by medical history, medication review, baseline physical examination, vital signs and clinical laboratory evaluations.
Key exclusion criteria (13 listed)
- Subjects with continuous headache (no headache free periods)
- Subjects using maintenance opioid medication
- Subjects who have started a medication with prophylactic migraine efficacy within the past 2 months
- Known hypersensitivity or allergic reaction to any of study ingredients (lidocaine, bupivicaine, any local anesthetics, and corticosteroids) or betadine.
- Use of any investigational medication within 90 days of the initial screening visit and/or concurrent enrolment in an investigational study
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 |
|---|---|---|
| bupivicaineAlso: Marcain, Marcaine, Sensorcaine, Vivacaine2.5 mL 0.5% bupivicaine | Drug | Active Injection |
| normal saline2.75 mL normal saline | Drug | Placebo Injection |
| methylprednisoloneAlso: Medrol, Solu-Medrol0.5 mL 20 mg methylprednisolone | Drug | Active Injection |
| lidocaineAlso: xylocaine0.25 mL 1% lidocaine | Drug | Placebo Injection |
Primary outcome
Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period
Time frame: 4 weeks pre-injection baseline, 4 weeks post-injection
The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.
3 secondary outcomes
Mean Frequency of Days With a Migraine
Time frame: 4 weeks post-injection
Mean Number of Hours With Moderate or Severe Migraine
Time frame: 4 weeks post-injection
Mean Number of Days With Acute Medication Use
Time frame: 4 weeks post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25505035Dilli E, Halker R, Vargas B, Hentz J, Radam T, Rogers R, Dodick D. Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study. Cephalalgia. 2015 Oct;35(11):959-68. doi: 10.1177/0333102414561872. Epub 2014 Dec 12.
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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.
David W. Dodick, M.D. principal investigator
Mayo Clinic
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 bupivicaine, normal saline and methylprednisolone in people with Migraine Headache, run by Mayo Clinic 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 5 inclusion and 13 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 20 Mar 2014. 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. 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?
Yes. Results are posted in the registry (first posted 25 Feb 2014). 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 Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period (time frame: 4 weeks pre-injection baseline, 4 weeks post-injection). 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 NCT00915473, 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 20 Mar 2014.