MigrainePhase 4NCT03159000
A Research Study of Greater Occipital Nerve Block as a Treatment for Acute Migraine Attacks
A Phase 4 study testing Saline and lidocaine/bupivacaine in people with Migraine, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Saline and lidocaine/bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Jun 2018
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling the international classification of headache disorders (ICHD3b) criteria for episodic migraine, presenting to clinic with an acute episodic migraine reported as at least a moderate pain level not lasting longer than 7 days at the time of injection.
Who cannot join
- subjects who have received greater occipital nerve block (GONB) in the past, subjects who in their own or the investigator's opinion are unable to describe their symptoms, subjects who have are scheduled to receive injection of onabotulinum toxin A within 72 hours, subjects who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Double-Blind, Placebo Controlled Trial of Greater Occipital Nerve Block for the Treatment of Migraine Attacks
Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB. In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure. 50 subjects will be entered into this study. This study is being conducted at Thomas Jefferson University only.
- Conditions
- Migraine
- Being tested
- Saline, lidocaine/bupivacaine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
1ml of 1/3 saline
lidocaine/bupivacaineCombination product
1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| GONB of lidocaine/bupivacaine | Experimental | The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally. The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection. Subjects who are not improved after 2 hours will be allowed to use their abortive treatment. Receives: Combination Product: lidocaine/bupivacaine |
| Placebo injection of 1/3 saline | Placebo comparator | The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally. The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection. Subjects who are not improved after 2 hours will be allowed to use their abortive treatment. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects experiencing headache improvement at 2 hours
Headache intensity on 4 point pain scale from moderate or severe to mild or none
Measured: 2 hours
Secondary outcomes (9)
Percentage of subjects experiencing headache improvement 10 minutes
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
Measured: 10 minutes
Percentage of subjects experiencing headache improvement at 30 minutes
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
Measured: 30 minutes
Percentage of subjects experiencing headache improvement at 1 hour
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
Measured: 1 hour
Percentage of subjects experiencing headache improvement at 24 hours
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
Measured: 24 hours
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
Measured: 10 minutes
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
Measured: 30 minutes
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
Measured: 1 hour
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
Measured: 2 hours
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 May 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
Why it stopped: Project never started - lack of resources and no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William B Young, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159000
- Sponsor's protocol ID
- GON/WBY/003
- Status last verified
- Nov 2021
- First submitted
- 26 Apr 2017
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo Controlled Trial of Greater Occipital Nerve Block for the Treatment of Migraine Attacks
- ClinicalTrials.gov ID
- NCT03159000
- Acronym / sponsor ID
- GON/WBY/003
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project never started - lack of resources and no subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 18 May 2017 (actual)
- 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.
Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB. In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure. 50 subjects will be entered into this study. This study is being conducted at Thomas Jefferson University only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GONB of lidocaine/bupivacaine | Experimental | Combination Product: lidocaine/bupivacaineThe injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally. The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection. Subjects who are not improved after 2 hours will be allowed to use their abortive treatment. |
| Placebo injection of 1/3 saline | Placebo comparator | Drug: SalineThe injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally. The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection. Subjects who are not improved after 2 hours will be allowed to use their abortive treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling the international classification of headache disorders (ICHD3b) criteria for episodic migraine, presenting to clinic with an acute episodic migraine reported as at least a moderate pain level not lasting longer than 7 days at the time of injection.
Key exclusion criteria (1 listed)
- subjects who have received greater occipital nerve block (GONB) in the past, subjects who in their own or the investigator's opinion are unable to describe their symptoms, subjects who have are scheduled to receive injection of onabotulinum toxin A within 72 hours, subjects who are pregnant or lactating.
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 |
|---|---|---|
| Saline1ml of 1/3 saline | Drug | Placebo injection of 1/3 saline |
| lidocaine/bupivacaine1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine | Combination product | GONB of lidocaine/bupivacaine |
Primary outcome
Percentage of subjects experiencing headache improvement at 2 hours
Time frame: 2 hours
Headache intensity on 4 point pain scale from moderate or severe to mild or none
9 secondary outcomes
Percentage of subjects experiencing headache improvement 10 minutes
Time frame: 10 minutes
Percentage of subjects experiencing headache improvement at 30 minutes
Time frame: 30 minutes
Percentage of subjects experiencing headache improvement at 1 hour
Time frame: 1 hour
Percentage of subjects experiencing headache improvement at 24 hours
Time frame: 24 hours
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes
Time frame: 10 minutes
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes
Time frame: 30 minutes
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour
Time frame: 1 hour
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours
Time frame: 2 hours
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours
Time frame: 24 hours
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 26 Nov 2021.
- Individual participant dataSharing planned: No
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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.
William B Young, MD principal investigator
Thomas Jefferson University
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 Saline and lidocaine/bupivacaine in people with Migraine, run by Thomas Jefferson University 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 1 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 26 Nov 2021. 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?
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?
Percentage of subjects experiencing headache improvement at 2 hours (time frame: 2 hours). 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 26 Nov 2021.