MigrainePhase 4SPGblockNCT03666663
Sphenopalatine Ganglion Blocks RCT
A Phase 4 study testing Lidocaine, Bupivacaine and Ropivacaine in people with Migraine, run by University of California, San Francisco at 1 site in United States.
Trial summary
RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Lidocaine, Bupivacaine and Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 8 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or more at time of consent
- Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
- Ability to provide consent for the research study
Who cannot join
- Pregnant or breast feeding within 4 weeks of enrollment
- Inability to communicate with the study team
- Patients who cannot read and understand English
- Deemed unsuitable for enrollment in study by the investigator
- Allergy to local anesthetics or saline
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Headache Center
San Francisco, California, 94115
About this study
Official title: UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.
RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.
Read the detailed description
Chronic Migraine is a brain disorder with high prevalence. It is the 7th leading cause of disability worldwide according the WHO.
SPG block is a treatment for migraine that has been used for two decades. It can be done by needle injection of anesthetic to the region of the SPG. However, there are now multiple catheter devices that can be used to non-invasively administer anesthetic topically through the nasal cavity to the region of the SPG where the anesthetic is then absorbed through thin membranes covering the SPG.
Various anesthetic agents have been studied however currently, to our knowledge, there is no head to head comparison of the various anesthetics used. Studies of SPG blocks in the setting of chronic migraine are few as compared to the use of SPG as acute treatment for migraine.
With the use of an RCT, we aim to determine the overall efficacy of SPG blocks used at longer intervals than have been studied in the past as compared to placebo, as well as to examine the relative efficacy of the anesthetics used most commonly and studied for SPG blocks.
We will be using an FDA cleared device, the Sphenocath which was developed and registered with the FDA for this specific population and purpose. The study intervention is the standard practice in the UCSF Headache Center to perform SPG blocks for our patients with chronic migraine. The frequency we use in clinical practice and that we plan to study is less often than in previous studies of this intervention in this population.
- Conditions
- Migraine
- Being tested
- Lidocaine, Bupivacaine, Ropivacaine, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Nasal application using the Sphenocath device- cleared by FDA
BupivacaineDrug
Nasal application using the Sphenocath device- cleared by FDA
RopivacaineDrug
Nasal application using the Sphenocath device- cleared by FDA
PlaceboDrug
Also called Placebo Saline
Placebo Saline using the Sphenocath device- cleared by FDA
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Participants will receive SPG blocks with lidocaine. Receives: Drug: Lidocaine |
| Bupivacaine | Experimental | Participants will receive SPG blocks with bupivacaine Receives: Drug: Bupivacaine |
| Ropivacaine | Experimental | Participants will receive SPG blocks with ropivacaine Receives: Drug: Ropivacaine |
| Placebo (saline) | Placebo comparator | Participants will receive SPG blocks with placebo (saline) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment
Reduction in headache days from baseline to month 8 of treatment as self- reported by the patients (yes/no) and as per headache diary and retrospective charts review documentation
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Feb 2019
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
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 (6)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Model description
- Randomized placebo controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Riggins, MD, Principal investigator, UCSF Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666663
- Sponsor's protocol ID
- 18-25736_SPG_2018.09
- Acronym
- SPGblock
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2018
- Last updated
- 11 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goadsby PJ, Zagami AS, Lambert GA. Neural processing of craniovascular pain: a synthesis of the central structures involved in migraine. Headache. 1991 Jun;31(6):365-71. doi: 10.1111/j.1526-4610.1991.hed3106365.x.
PubMed 1889975Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.
PubMed 21956040Robbins MS, Robertson CE, Kaplan E, Ailani J, Charleston L 4th, Kuruvilla D, Blumenfeld A, Berliner R, Rosen NL, Duarte R, Vidwan J, Halker RB, Gill N, Ashkenazi A. The Sphenopalatine Ganglion: Anatomy, Pathophysiology, and Therapeutic Targeting in Headache. Headache. 2016 Feb;56(2):240-58. doi: 10.1111/head.12729. Epub 2015 Nov 30.
PubMed 26615983Mehta D, Leary MC, Yacoub HA, El-Hunjul M, Kincaid H, Koss V, Wachter K, Malizia D, Glassman B, Castaldo JE. The Effect of Regional Anesthetic Sphenopalatine Ganglion Block on Self-Reported Pain in Patients With Status Migrainosus. Headache. 2019 Jan;59(1):69-76. doi: 10.1111/head.13390. Epub 2018 Jul 25.
PubMed 30043973Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine Ganglion Block for the Treatment of Acute Migraine Headache. Pain Res Treat. 2018 May 7;2018:2516953. doi: 10.1155/2018/2516953. eCollection 2018.
PubMed 29862074Mojica J, Mo B, Ng A. Sphenopalatine Ganglion Block in the Management of Chronic Headaches. Curr Pain Headache Rep. 2017 Jun;21(6):27. doi: 10.1007/s11916-017-0626-8.
PubMed 28432602
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.
- ClinicalTrials.gov ID
- NCT03666663
- Acronym / sponsor ID
- SPGblock / 18-25736_SPG_2018.09
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Posted 11 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.
Detailed description
Chronic Migraine is a brain disorder with high prevalence. It is the 7th leading cause of disability worldwide according the WHO.
SPG block is a treatment for migraine that has been used for two decades. It can be done by needle injection of anesthetic to the region of the SPG. However, there are now multiple catheter devices that can be used to non-invasively administer anesthetic topically through the nasal cavity to the region of the SPG where the anesthetic is then absorbed through thin membranes covering the SPG.
Various anesthetic agents have been studied however currently, to our knowledge, there is no head to head comparison of the various anesthetics used. Studies of SPG blocks in the setting of chronic migraine are few as compared to the use of SPG as acute treatment for migraine.
With the use of an RCT, we aim to determine the overall efficacy of SPG blocks used at longer intervals than have been studied in the past as compared to placebo, as well as to examine the relative efficacy of the anesthetics used most commonly and studied for SPG blocks.
We will be using an FDA cleared device, the Sphenocath which was developed and registered with the FDA for this specific population and purpose. The study intervention is the standard practice in the UCSF Headache Center to perform SPG blocks for our patients with chronic migraine. The frequency we use in clinical practice and that we plan to study is less often than in previous studies of this intervention in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineParticipants will receive SPG blocks with lidocaine. |
| Bupivacaine | Experimental | Drug: BupivacaineParticipants will receive SPG blocks with bupivacaine |
| Ropivacaine | Experimental | Drug: RopivacaineParticipants will receive SPG blocks with ropivacaine |
| Placebo (saline) | Placebo comparator | Drug: PlaceboParticipants will receive SPG blocks with placebo (saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or more at time of consent
- Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
- Ability to provide consent for the research study
Key exclusion criteria (5 listed)
- Pregnant or breast feeding within 4 weeks of enrollment
- Inability to communicate with the study team
- Patients who cannot read and understand English
- Deemed unsuitable for enrollment in study by the investigator
- Allergy to local anesthetics or saline
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 |
|---|---|---|
| LidocaineNasal application using the Sphenocath device- cleared by FDA | Drug | Lidocaine |
| BupivacaineNasal application using the Sphenocath device- cleared by FDA | Drug | Bupivacaine |
| RopivacaineNasal application using the Sphenocath device- cleared by FDA | Drug | Ropivacaine |
| PlaceboAlso: Placebo SalinePlacebo Saline using the Sphenocath device- cleared by FDA | Drug | Placebo (saline) |
Primary outcome
Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment
Time frame: 8 months
Reduction in headache days from baseline to month 8 of treatment as self- reported by the patients (yes/no) and as per headache diary and retrospective charts review documentation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1889975Goadsby PJ, Zagami AS, Lambert GA. Neural processing of craniovascular pain: a synthesis of the central structures involved in migraine. Headache. 1991 Jun;31(6):365-71. doi: 10.1111/j.1526-4610.1991.hed3106365.x.
- Background: PubMed 21956040Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.
- Background: PubMed 26615983Robbins MS, Robertson CE, Kaplan E, Ailani J, Charleston L 4th, Kuruvilla D, Blumenfeld A, Berliner R, Rosen NL, Duarte R, Vidwan J, Halker RB, Gill N, Ashkenazi A. The Sphenopalatine Ganglion: Anatomy, Pathophysiology, and Therapeutic Targeting in Headache. Headache. 2016 Feb;56(2):240-58. doi: 10.1111/head.12729. Epub 2015 Nov 30.
- Background: PubMed 30043973Mehta D, Leary MC, Yacoub HA, El-Hunjul M, Kincaid H, Koss V, Wachter K, Malizia D, Glassman B, Castaldo JE. The Effect of Regional Anesthetic Sphenopalatine Ganglion Block on Self-Reported Pain in Patients With Status Migrainosus. Headache. 2019 Jan;59(1):69-76. doi: 10.1111/head.13390. Epub 2018 Jul 25.
- Background: PubMed 29862074Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine Ganglion Block for the Treatment of Acute Migraine Headache. Pain Res Treat. 2018 May 7;2018:2516953. doi: 10.1155/2018/2516953. eCollection 2018.
- Background: PubMed 28432602Mojica J, Mo B, Ng A. Sphenopalatine Ganglion Block in the Management of Chronic Headaches. Curr Pain Headache Rep. 2017 Jun;21(6):27. doi: 10.1007/s11916-017-0626-8.
- Individual participant dataSharing planned: No
Related trials for Migraine
Recruiting
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Migraine, Migraine in Adolescence
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
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.
Nina Riggins, MD principal investigator
UCSF Headache Center
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 Lidocaine, Bupivacaine and Ropivacaine in people with Migraine, run by University of California, San Francisco 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 3 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: finished, as of the sponsor's last update on 11 Oct 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?
Yes. Results are posted in the registry (first posted 11 Oct 2021). 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 a Reduction in Headache Days From Baseline to Month 8 of Treatment (time frame: 8 months). 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 NCT03666663, which also lists 6 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 11 Oct 2021.