Chronic MigraineNCT04194008
Efficacy and Safety of Nerivio Device for Acute Treatment of Migraine in People With Chronic Migraine
A study testing Nerivio in people with Chronic Migraine, run by Theranica at 10 sites in United States.
Trial summary
A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases: Phase I - Run-in: Eligible participants will be trained to use a smartphone migraine diary application. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- Nerivio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Nov 2019to 30 Aug 2020
- Phase
- Interventional
- 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
- Participants aged 18-75 years old.
- Participants meeting the International Classification of Headache Disorders-3 (ICHD-3) diagnostic criteria for chronic migraine
- Participants experiencing between 15 to 23 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation
- Participants have personal access to a smartphone
- Participants must be able and willing to comply with the protocol
- Participants must be able and willing to provide written informed consent
Who cannot join
- Participants with an active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- Participants with uncontrolled epilepsy.
- Lack of efficacy, after an adequate therapeutic trial, of at least two migraine specific acute medications.
- Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study
- Pregnant, trying to get pregnant or breastfeeding female participants
Show all 10Show fewer
- Subjects participating in any other interventional clinical study.
- Participants without basic cognitive and/or motor skills needed to operate a smartphone
- Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
- Participants who have previous experience with the device
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
StudyMetrix Research, LLC
City of Saint Peters, Missouri, 63303
Hartford Healthcare Center
Hartford, Connecticut, 06102
Nashville neuroscience
Nashville, Tennessee, 37203
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15220
Island Neurological
Plainview, New York, 11803
Headache Neurology Research Institute
Ridgeland, Mississippi, 39157
California Medical Clinic for Headache
Santa Monica, California, 90404
ClinVest
Springfield, Missouri, 65810
Mercy Hospital
St Louis, Missouri, 63141
About this study
Official title: An Open Label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of Nerivio, a Remote Electrical Neuromodulation Device, for Acute Treatment of Migraine in People With Chronic Migraine
A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases:
Phase I - Run-in:
Read more
Eligible participants will be trained to use a smartphone migraine diary application. During the 4 weeks of this phase, participants will be instructed to report all their migraines and headaches at onset, 2 hours and 24 hours post report .
Phase II - Treatment:
A 4-week treatment phase in which participants will be asked to treat their migraine headaches with the Nerivio device and report it using the smartphone application at baseline, 2 hours and 24 hours post-treatment.
Phase III - Follow-up:
An 8-week follow-up phase in which participants will incorporate the Nerivio device into their usual care according to their preference (Nerivio only, medication only, both or none). Participants will be asked to report all their migraines or headaches at onset, 2 hours post report and 24 hours post report.
Read the detailed description
This open label study includes up to four visits. The enrollment and application training may occur in two separate visits instead of one.
First visit - The first visit will include screening, enrollment and training on the application.
Enrollment: The screening process will include an eligibility assessment and a urine pregnancy test. Following successful screening, the site staff will provide the participants with study related information, perform an enrollment interview and receive an informed consent from the participants. During this visit, participants will complete baseline questionnaires that included information on the frequency and severity of their migraine attacks, typical associated symptoms, use of preventive and acute treatments, and the effect that their migraine attacks have on their daily routine and quality of life.
Application training: Eligible participants who enroll to the study will be trained to use the diary mode of the application that is installed on their own smartphones. The participants will be instructed to report the onset of all their migraines and headaches and complete a migraine diary questions regarding their pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) as well as rate their stress level and functional disability at baseline, 2- and 24-hours post-treatment. At the beginning of each treatment, participants will also be asked to report the time elapsed from attack onset. The site personnel will be required to document the training session in the Case Report Form (CRF).
Run-in phase: After the enrollment visit, participants will undergo a 4-week migraine diary phase aimed to collect baseline migraine characteristics and further assess eligibility. The participants will use the app to record pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) as well as the effect that their migraine attacks have on their daily routine and quality of life, at baseline, 2- and 24-hours post-treatment. These reports will be transferred by the application to the electronic data capture (EDC) system, where they will be collected and registered.
Participants who report at least 6 qualifying migraine headaches with pain data at baseline and 2 hours post-treatment will continue to the treatment phase.
Second visit- Device training: Eligible participants who successfully complete the run-in phase will receive the Nerivio™ device. The device will be registered and connected by Bluetooth to their smartphone. During this visit, participants will be trained to use the device. Device training will include finding the optimal individual stimulation intensity level (perceptible but not painful), that will be subject to change during the treatment phase. The site staff will also carefully review with the patient how to identify a qualifying migraine headache (see below) and provide detailed instructions on study procedures.
If the research staff recognizes that the participant cannot tolerate the feeling of the electrical stimulation, the participant may be withdrawn from the study.
During the training, participants will also be informed on the key elements which are critical for the successful conduct of the study:
- Treatments of migraine and headaches with Nerivio™ should be performed as soon as possible after migraine headache or aura began and always within one hour of symptoms onset. Treatments of mild headaches are accepted.
- Avoid taking rescue medications within two hours post-treatment (2 hours from start of treatment), if possible.
- The treatment should be performed for at least 30 minutes (the recommended treatment duration is 45 minutes).
The site personnel will be required to document the training session in the CRF.
Treatment phase: Participants will be instructed to use the device for the treatment of migraine and/or headaches (see below) as soon as possible and always within 60 minutes of onset during a period of up to 4 weeks. Participants will be instructed to use the device with the intensity level identified during the device training visit (and adjust as necessary) and make sure the stimulation is perceptible but not painful. Participants will be instructed to avoid taking rescue medications within 2 hours post-treatment. If medications are used, participants will be instructed to record in the app when and which medication was taken at 2- and 24-hours post treatment. The participants will use the app to record pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) as well as the effect that their migraine attacks have on their daily routine and quality of life, at baseline, 2- and 24-hours post-treatment. At the beginning of each treatment, participants will also be asked to report the time elapsed from attack onset. Adverse events will be reported throughout this phase of the study directly to the site staff.
Participants who do not achieve satisfactory relief at 2 hours post-treatment may treat again with the Nerivio™ device or may treat with usual care at that time or any time thereafter if the headache does not resolve. Participants will also be able to treat headache recurrence with the device. Migraine headaches that are not treated with the device may be treated with usual care.
The first reported treatment will be considered a "training" treatment, aimed to verify that the participants use the device properly, and will only be included in the safety analysis. The efficacy evaluation will be performed on the first treatment of a qualifying attack (see below) following the training treatment (hereby termed "test treatment").
Third visit- Follow-up phase:
Following the 4-week period of the treatment phase, participants will return to the clinic to fill questionnaires assessing satisfaction and user experience. All participants who complete the treatment phase will enter an additional 8-week phase in which the device can be incorporate into their usual care. Participants will treat their migraines and headaches according to their preference- treatment with Nerivio only, treatment with medication only, both treatment options, or none. Participants will be asked to report all their migraine headaches at onset (migraines or headache), regardless if they are using the device or not. The participants will use the app to record pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) as well as the effect that their migraine attacks have on their daily routine and quality of life, at baseline, 2- and 24-hours post-treatment.
Fourth (final) visit - End of study:
Participants will return to the clinic following the end of the follow-up phase, at which time they will return the device. The participants will have the option of returning the device by mail instead of an on-site visit. Participants may be asked to fill additional questionnaires on their migraine and their experience with the device.
- Conditions
- Chronic Migraine
- Being tested
- Nerivio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerivioDevice
A remote electrical neuromodulation (REN) device for the acute treatment of migraines.The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
| Study group | Role | What they receive |
|---|---|---|
| Nerivio device treatment | Experimental | Treatment with active Nerivio device Receives: Device: Nerivio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief at 2 Hours Post-treatment
The proportion of subjects reporting, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
Measured: 2 hours post-treatment
Secondary outcomes (4)
Pain-free at 2 Hours Post-treatment
The proportion of subjects reporting, for the test treatment, no pain at 2 hours post-treatment without the use of rescue medication. Pain-free is defined as improvement from mild, moderate, or severe pain to none. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
Measured: 2 hours post-treatment
Disappearance of Nausea at 2 Hours Post-treatment
The proportion of subjects presented nausea at the migraine onset and reported disappearance of nausea at 2 hours post-treatment of the test treatment
Measured: 2 hours post treatment
Disappearance of Photophobia at 2 Hours Post-treatment
The proportion of subjects presented photohobia at the migraine onset and reported disappearance of photophobia at 2 hours post-treatment of the test treatment
Measured: 2 hours post treatment
Disappearance of Phonophobia at 2 Hours Post-treatment
The proportion of subjects presented phonophobia at the migraine onset and reported disappearance of phonophobia at 2 hours post-treatment of the test treatment
Measured: 2 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start18 Nov 2019
- Primary completion22 May 2020
- Study completion30 Aug 2020
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 Chronic MigraineStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Grosberg, MD, Principal investigator, Hartford Healthcare Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194008
- Sponsor's protocol ID
- TCH006
- Status last verified
- Sep 2020
- First submitted
- 4 Dec 2019
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Grosberg B, Rabany L, Lin T, Harris D, Vizel M, Ironi A, O'Carroll CP, Schim J. Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study. Pain Rep. 2021 Oct 14;6(4):e966. doi: 10.1097/PR9.0000000000000966. eCollection 2021 Nov-Dec.
PubMed 34667919
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of Nerivio, a Remote Electrical Neuromodulation Device, for Acute Treatment of Migraine in People With Chronic Migraine
- ClinicalTrials.gov ID
- NCT04194008
- Acronym / sponsor ID
- TCH006
- Conditions
- Chronic Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases:
Phase I - Run-in:
Eligible participants will be trained to use a smartphone migraine diary application. During the 4 weeks of this phase, participants will be instructed to report all their migraines and headaches at onset, 2 hours and 24 hours post report .
Phase II - Treatment:
A 4-week treatment phase in which participants will be asked to treat their migraine headaches with the Nerivio device and report it using the smartphone application at baseline, 2 hours and 24 hours post-treatment.
Phase III - Follow-up:
An 8-week follow-up phase in which participants will incorporate the Nerivio device into their usual care according to their preference (Nerivio only, medication only, both or none). Participants will be asked to report all their migraines or headaches at onset, 2 hours post report and 24 hours post report.
Detailed description
This open label study includes up to four visits. The enrollment and application training may occur in two separate visits instead of one.
First visit - The first visit will include screening, enrollment and training on the application.
Enrollment: The screening process will include an eligibility assessment and a urine pregnancy test. Following successful screening, the site staff will provide the participants with study related information, perform an enrollment interview and receive an informed consent from the participants. During this visit, participants will complete baseline questionnaires that included information on the frequency and severity of their migraine attacks, typical associated symptoms, use of preventive and acute treatments, and the effect that their migraine attacks have on their daily routine and quality of life.
Application training: Eligible participants who enroll to the study will be trained to use the diary mode of the application that is installed on their own smartphones. The participants will be instructed to report the onset of all their migraines and headaches and complete a migraine diary questions regarding their pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) as well as rate their stress level and functional disability at baseline, 2- and 24-hours post-treatment. At the beginning of each treatment, participants will also be asked to report the time elapsed from attack onset. The site personnel will be required to document the training session in the Case Report Form (CRF).
Run-in phase: After the enrollment visit, participants will undergo a 4-week migraine diary phase aimed to collect baseline migraine characteristics and further assess eligibility. The participants will use the app to record pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) as well as the effect that their migraine attacks have on their daily routine and quality of life, at baseline, 2- and 24-hours post-treatment. These reports will be transferred by the application to the electronic data capture (EDC) system, where they will be collected and registered.
Participants who report at least 6 qualifying migraine headaches with pain data at baseline and 2 hours post-treatment will continue to the treatment phase.
Second visit- Device training: Eligible participants who successfully complete the run-in phase will receive the Nerivio™ device. The device will be registered and connected by Bluetooth to their smartphone. During this visit, participants will be trained to use the device. Device training will include finding the optimal individual stimulation intensity level (perceptible but not painful), that will be subject to change during the treatment phase. The site staff will also carefully review with the patient how to identify a qualifying migraine headache (see below) and provide detailed instructions on study procedures.
If the research staff recognizes that the participant cannot tolerate the feeling of the electrical stimulation, the participant may be withdrawn from the study.
During the training, participants will also be informed on the key elements which are critical for the successful conduct of the study:
- Treatments of migraine and headaches with Nerivio™ should be performed as soon as possible after migraine headache or aura began and always within one hour of symptoms onset. Treatments of mild headaches are accepted.
- Avoid taking rescue medications within two hours post-treatment (2 hours from start of treatment), if possible.
- The treatment should be performed for at least 30 minutes (the recommended treatment duration is 45 minutes).
The site personnel will be required to document the training session in the CRF.
Treatment phase: Participants will be instructed to use the device for the treatment of migraine and/or headaches (see below) as soon as possible and always within 60 minutes of onset during a period of up to 4 weeks. Participants will be instructed to use the device with the intensity level identified during the device training visit (and adjust as necessary) and make sure the stimulation is perceptible but not painful. Participants will be instructed to avoid taking rescue medications within 2 hours post-treatment. If medications are used, participants will be instructed to record in the app when and which medication was taken at 2- and 24-hours post treatment. The participants will use the app to record pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) as well as the effect that their migraine attacks have on their daily routine and quality of life, at baseline, 2- and 24-hours post-treatment. At the beginning of each treatment, participants will also be asked to report the time elapsed from attack onset. Adverse events will be reported throughout this phase of the study directly to the site staff.
Participants who do not achieve satisfactory relief at 2 hours post-treatment may treat again with the Nerivio™ device or may treat with usual care at that time or any time thereafter if the headache does not resolve. Participants will also be able to treat headache recurrence with the device. Migraine headaches that are not treated with the device may be treated with usual care.
The first reported treatment will be considered a "training" treatment, aimed to verify that the participants use the device properly, and will only be included in the safety analysis. The efficacy evaluation will be performed on the first treatment of a qualifying attack (see below) following the training treatment (hereby termed "test treatment").
Third visit- Follow-up phase:
Following the 4-week period of the treatment phase, participants will return to the clinic to fill questionnaires assessing satisfaction and user experience. All participants who complete the treatment phase will enter an additional 8-week phase in which the device can be incorporate into their usual care. Participants will treat their migraines and headaches according to their preference- treatment with Nerivio only, treatment with medication only, both treatment options, or none. Participants will be asked to report all their migraine headaches at onset (migraines or headache), regardless if they are using the device or not. The participants will use the app to record pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) as well as the effect that their migraine attacks have on their daily routine and quality of life, at baseline, 2- and 24-hours post-treatment.
Fourth (final) visit - End of study:
Participants will return to the clinic following the end of the follow-up phase, at which time they will return the device. The participants will have the option of returning the device by mail instead of an on-site visit. Participants may be asked to fill additional questionnaires on their migraine and their experience with the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerivio device treatment | Experimental | Device: NerivioTreatment with active Nerivio device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants aged 18-75 years old.
- Participants meeting the International Classification of Headache Disorders-3 (ICHD-3) diagnostic criteria for chronic migraine
- Participants experiencing between 15 to 23 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation
- Participants have personal access to a smartphone
- Participants must be able and willing to comply with the protocol
Key exclusion criteria (10 listed)
- Participants with an active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- Participants with uncontrolled epilepsy.
- Lack of efficacy, after an adequate therapeutic trial, of at least two migraine specific acute medications.
- Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the 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 |
|---|---|---|
| NerivioA remote electrical neuromodulation (REN) device for the acute treatment of migraines.The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. | Device | Nerivio device treatment |
Primary outcome
Pain Relief at 2 Hours Post-treatment
Time frame: 2 hours post-treatment
The proportion of subjects reporting, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
4 secondary outcomes
Pain-free at 2 Hours Post-treatment
Time frame: 2 hours post-treatment
Disappearance of Nausea at 2 Hours Post-treatment
Time frame: 2 hours post treatment
Disappearance of Photophobia at 2 Hours Post-treatment
Time frame: 2 hours post treatment
Disappearance of Phonophobia at 2 Hours Post-treatment
Time frame: 2 hours post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34667919Grosberg B, Rabany L, Lin T, Harris D, Vizel M, Ironi A, O'Carroll CP, Schim J. Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study. Pain Rep. 2021 Oct 14;6(4):e966. doi: 10.1097/PR9.0000000000000966. eCollection 2021 Nov-Dec.
- 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.
Brian Grosberg, MD principal investigator
Hartford Healthcare Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerivio in people with Chronic Migraine, run by Theranica at 10 sites 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 6 inclusion and 10 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 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?
Pain Relief at 2 Hours Post-treatment (time frame: 2 hours post-treatment). 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 NCT04194008, 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 2 Feb 2021.