MigraineNCT04828707
Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention
A study testing Nerivio active device in people with Migraine, run by Theranica at 16 sites in United States.
Trial summary
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. This study intends to demonstrate the safety and efficacy of the Nerivio for migraine prevention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine
- What is being tested?
- Nerivio active device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 335 participants
- Where
- 16 sitesUnited States
- Study dates
- 13 Apr 2021to 10 Oct 2022
- 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
- Age 18-75 years old.
- Must have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic (at least 15 days of Headache Days(HD)/ month with migraine days (migraine with or without aura) at least 8 days/ month for > 3 months) or non-chronic migraine.
- History of 6 to 24 headache days per 28-day period for each of the 3 months preceding study enrolment (based on participant report).
- Subject on prophylactic migraine treatment are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 2 months prior to the screening visit, and the dose is not expected to change during the course of the study.
- Have personal access to a smartphone (24/7).
- Must be able and willing to comply with the protocol.
- Must be able and willing to provide informed consent..
Who cannot join
- An active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Uncontrolled epilepsy.
- History of use of opioids or barbiturates on more than 4 days a month in the last 6 months.
- Current participation in any other interventional clinical study
- Subject without basic cognitive and motor skills required for operating a smartphone.
- Pregnant or breastfeeding.
- Other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
- Prior experience with the Nerivio device.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
DENT Neurosciences Research Center
Amherst, New York, 14226
RecioMed Clinical Research
Boynton Beach, Florida, 33472
The Neurology Center of Southern California
Carlsbad, California, 92011
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Prevention & Strengthening Solutions, Inc.
Columbia, South Carolina, 29203
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, 33157
Deaconess Clinic
Evansville, Indiana, 47713
Hartford Headache Center
Hartford, Connecticut, 06107
West Virginia University Medicine
Morgantown, West Virginia, 26506
Newport Beach Clinical Research Associates
Newport Beach, California, 92663
Four Rivers Clinical Research
Paducah, Kentucky, 42001
Evolve Clinical Research
Phoenix, Arizona, 85013
Headache Neurology Research Institute
Ridgeland, Mississippi, 39157
ClinVest Research
Springfield, Missouri, 65810
Ocean medical research
Toms River, New Jersey, 08755
About this study
Official title: A Prospective, Randomized, Double-blind, Sham-controlled Multi-center Clinical Study Assessing the Safety and Efficacy of Nerivio for the Preventive Treatment of Migraine
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. This study intends to demonstrate the safety and efficacy of the Nerivio for migraine prevention.
The study is a prospective, randomized, double-blind, sham-controlled, multicenter study, conducted in three phases.
Read more
The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase, an 8-week double-blind preventive treatment phase, and a 4-week open-label phase.
Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow-up pre-emptive phase.
The primary endpoint is the mean change in the average of migraine headache days per month comparing the 4-week baseline phase (weeks 1 through 4) with the last 28 days of the treatment phase (weeks 9 through 12).
Read the detailed description
Nerivio is a neuromodulation device approved for the acute treatment of migraine with or without aura in patients 12 years of age or older. The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM stimulate endogenous analgesic mechanism. Treatments are self-administered by the user at the onset of a migraine attack. this study intends to demonstrate the safety and efficacy of the Nwrivio for migraine prevention.
The study is a prospective, randomized, double-blind, sham-controlled, multicenter trial, conducted in three phases. The ratio between treatment and control groups will be 1:1, stratified by center and patient type (chronic/non-chronic). The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase. Eligible participants will enter an 8-week double-blind preventive treatment phase. Following the preventive treatment phase, patients will be offered to participate in a 4-week open-label pre-emptive treatment phase or continue their prevention treatment with an active device, according to their eligibility.
Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow up pre-emptive phase
Phase I - Baseline - 4 weeks (weeks 1 through 4):
Eligible participants will install the Nerivio app on their smartphones and will be instructed to record daily their migraine/headaches symptoms and medication use on the Nerivio app.
Transition to the treatment phase: Participants who meet the following criteria in the baseline phase will be eligible to continue to the treatment phase:
- Complete the diary in at least 22 out of the 28 days during the baseline phase (80%)
- Have between 6 to 24 headache days during the 28-day baseline period
- At least 4 of their headache days during the baseline phase fulfill the International Classification of Headache Disorders 3rd edition (ICHD-3) criteria for migraine (migraine without aura [code 1.1; C and D] or with aura [code 1.2; B and C], or probable migraine, or headaches requiring the use of migraine-specific medications including triptans, gepants or ergot derivatives).
Phase II - treatment phase (prevention) - 8 weeks (weeks 5 through 12):
Participants who meet the baseline phase requirements will be randomized in a 1:1 ratio to active and sham groups. Participants will be instructed to complete a daily diary (in the Nerivio app) about their headaches, associated symptoms, and medication use. They will also be instructed to conduct a 45-minute treatment with Nerivio every other day.
Transition to the follow-up phase (open label):
At the end of the treatment phase, participants from both arms (active and sham) may continue to a follow-up phase in which they will receive an active device that can be used during this phase. The data of all participants will be used for safety analyses.
The data of participants from the baseline and treatment phases will be used to assess their eligibility to participate in the pre-emptive follow-up phase. Participants eligible for the follow-up phase meet the following conditions:
- Between 6-16 headache days during the baseline phase.
- Participants experience prodrome symptoms within 24 hours prior to the onset of their migraine headache in at least half of their migraine attacks during the baseline phase.
- Participants completed the daily questionnaires in at least 70% of the days during the treatment phase.
- Treated every other day in at least 24 and less than 33 days during the 56 days of the treatment phase.
All adverse events will be reported.
Phase III - Follow-up phase (open label) - 4 weeks (weeks 13 through 16):
All participants will receive an active Nerivio device to use during the follow-up phase. Participants who do not meet the above requirements will be able to enter into the safety follow-up and continue to use Nerivio every other day for the preventive treatment of migraine. They will be instructed to compete a daily diary as was done in the treatment phase.
Participants who meet the above requirements will enter the pre-emptive follow-up phase and be instructed to conduct a 45-minute device treatment within 60 minutes of prodrome symptom onset. Participants will be instructed to complete questionnaires regarding their headache, prodrome symptoms, and medication use at baseline (start of treatment), 2 hours post-treatment, and 24 hours post-treatment. In addition, participants will be instructed to continue to report the daily diary, as performed in the other phases of the study.
All adverse events will be reported.
- Conditions
- Migraine
- Being tested
- Nerivio active device, Nerivio sham device
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerivio active deviceDevice
Nerivio neurostimulator of conditional pain modulation (CPM)
Nerivio sham deviceDevice
Nerivio neurostimulator with an electrical output not intended for neurostimulation
| Study group | Role | What they receive |
|---|---|---|
| Migraine prevention treatment with active Nerivio | Active comparator | Participants will treat with an active Nerivio device every other day for migraine prevention. Receives: Device: Nerivio active device |
| Migraine prevention treatment with sham Nerivio | Sham comparator | Participants will treat with a sham (placebo) Nerivio device every other day for migraine prevention. Receives: Device: Nerivio sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Migraine Days
The mean reduction in the number of migraine days per month during the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12) compare to the 4-week baseline phase (weeks 1 through 4)
A migraine day is defined as a calendar day with a headache that is accompanied by at least one of the following symptoms: aura, photophobia, phonophobia, nausea and/or vomiting; or a calendar day with a headache that is treated with a migraine-specific acute medication.
Measured: 3 months
Rate of Adverse Events (Safety and Tolerability)
Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and Device-related Adverse Events
Measured: 3 months
Secondary outcomes (5)
Reduction in Moderate/Severe Headache Days
The mean reduction in the number of moderate/severe headache days per month during the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12) compare to the 4-week baseline phase (weeks 1 through 4)
A moderate/severe headache day is defined as a calendar day with a moderate or severe headache.
Measured: 3 months
Reduction Headache Days
The mean reduction in the number of headache days per month during the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12) compare to the 4-week baseline phase (weeks 1 through 4)
A headache day is defined as a calendar day with headache (at any severity).
Measured: 3 months
Reduction of 50% in Headache Days
Percentage of patients achieving at least 50% reduction from baseline in the mean number of headache days (all severities) per month in the last 4 weeks of the treatment phase (weeks 9 through 12).
Measured: 3 months
Increase in Headache Impact Test-6 (HIT-6) Score at the End of the Last 28 Days (4 Weeks) of the Treatment Phase (Weeks 9 Through 12) Compare to the HIT-6 Score at the End of the 4-week Baseline Phase (Weeks 1 Through 4)
Headache Impact Test-6 (HIT-6) questionnaire is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home, and in social situations. the questionnaire contains 6 questions with a total score between 36 to 78. Higher score interpret as better patient outcome.
Measured: 3 months
Reduction in Migraine-Specific Quality-of-Life (MSQ) Questionnaire Score at the End of the Last 28 Days (4 Weeks) of the Treatment Phase (Weeks 9 Through 12) Compare to the MSQ Score at the End of the 4-week Baseline Phase (Weeks 1 Through 4)
The migraine Specific Quality-of-Life questionnaire (MSQ) is a tool to measure the impact of migraine on your ability to function on the job, at school, at home, and in social situations. The questionnaire contains 14 questions with a total score between 0 to 84. Lower score interprets as better patient outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start13 Apr 2021
- Primary completion31 Aug 2022
- Study completion10 Oct 2022
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, sham-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Cowan, MD, Study chair, Stanford Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828707
- Sponsor's protocol ID
- TCH008
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2021
- Last updated
- 15 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Monteith TS, Stark-Inbar A, Shmuely S, Harris D, Garas S, Ironi A, Kalika P, Irwin SL. Remote electrical neuromodulation (REN) wearable device for adolescents with migraine: a real-world study of high-frequency abortive treatment suggests preventive effects. Front Pain Res (Lausanne). 2023 Nov 6;4:1247313. doi: 10.3389/fpain.2023.1247313. eCollection 2023.
PubMed 38028429
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Sham-controlled Multi-center Clinical Study Assessing the Safety and Efficacy of Nerivio for the Preventive Treatment of Migraine
- ClinicalTrials.gov ID
- NCT04828707
- Acronym / sponsor ID
- TCH008
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 15 Mar 2023
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 neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. This study intends to demonstrate the safety and efficacy of the Nerivio for migraine prevention.
The study is a prospective, randomized, double-blind, sham-controlled, multicenter study, conducted in three phases.
The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase, an 8-week double-blind preventive treatment phase, and a 4-week open-label phase.
Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow-up pre-emptive phase.
The primary endpoint is the mean change in the average of migraine headache days per month comparing the 4-week baseline phase (weeks 1 through 4) with the last 28 days of the treatment phase (weeks 9 through 12).
Detailed description
Nerivio is a neuromodulation device approved for the acute treatment of migraine with or without aura in patients 12 years of age or older. The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM stimulate endogenous analgesic mechanism. Treatments are self-administered by the user at the onset of a migraine attack. this study intends to demonstrate the safety and efficacy of the Nwrivio for migraine prevention.
The study is a prospective, randomized, double-blind, sham-controlled, multicenter trial, conducted in three phases. The ratio between treatment and control groups will be 1:1, stratified by center and patient type (chronic/non-chronic). The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase. Eligible participants will enter an 8-week double-blind preventive treatment phase. Following the preventive treatment phase, patients will be offered to participate in a 4-week open-label pre-emptive treatment phase or continue their prevention treatment with an active device, according to their eligibility.
Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow up pre-emptive phase
Phase I - Baseline - 4 weeks (weeks 1 through 4):
Eligible participants will install the Nerivio app on their smartphones and will be instructed to record daily their migraine/headaches symptoms and medication use on the Nerivio app.
Transition to the treatment phase: Participants who meet the following criteria in the baseline phase will be eligible to continue to the treatment phase:
- Complete the diary in at least 22 out of the 28 days during the baseline phase (80%)
- Have between 6 to 24 headache days during the 28-day baseline period
- At least 4 of their headache days during the baseline phase fulfill the International Classification of Headache Disorders 3rd edition (ICHD-3) criteria for migraine (migraine without aura [code 1.1; C and D] or with aura [code 1.2; B and C], or probable migraine, or headaches requiring the use of migraine-specific medications including triptans, gepants or ergot derivatives).
Phase II - treatment phase (prevention) - 8 weeks (weeks 5 through 12):
Participants who meet the baseline phase requirements will be randomized in a 1:1 ratio to active and sham groups. Participants will be instructed to complete a daily diary (in the Nerivio app) about their headaches, associated symptoms, and medication use. They will also be instructed to conduct a 45-minute treatment with Nerivio every other day.
Transition to the follow-up phase (open label):
At the end of the treatment phase, participants from both arms (active and sham) may continue to a follow-up phase in which they will receive an active device that can be used during this phase. The data of all participants will be used for safety analyses.
The data of participants from the baseline and treatment phases will be used to assess their eligibility to participate in the pre-emptive follow-up phase. Participants eligible for the follow-up phase meet the following conditions:
- Between 6-16 headache days during the baseline phase.
- Participants experience prodrome symptoms within 24 hours prior to the onset of their migraine headache in at least half of their migraine attacks during the baseline phase.
- Participants completed the daily questionnaires in at least 70% of the days during the treatment phase.
- Treated every other day in at least 24 and less than 33 days during the 56 days of the treatment phase.
All adverse events will be reported.
Phase III - Follow-up phase (open label) - 4 weeks (weeks 13 through 16):
All participants will receive an active Nerivio device to use during the follow-up phase. Participants who do not meet the above requirements will be able to enter into the safety follow-up and continue to use Nerivio every other day for the preventive treatment of migraine. They will be instructed to compete a daily diary as was done in the treatment phase.
Participants who meet the above requirements will enter the pre-emptive follow-up phase and be instructed to conduct a 45-minute device treatment within 60 minutes of prodrome symptom onset. Participants will be instructed to complete questionnaires regarding their headache, prodrome symptoms, and medication use at baseline (start of treatment), 2 hours post-treatment, and 24 hours post-treatment. In addition, participants will be instructed to continue to report the daily diary, as performed in the other phases of the study.
All adverse events will be reported.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, sham-controlled
| Arm | Type | Receives |
|---|---|---|
| Migraine prevention treatment with active Nerivio | Active comparator | Device: Nerivio active deviceParticipants will treat with an active Nerivio device every other day for migraine prevention. |
| Migraine prevention treatment with sham Nerivio | Sham comparator | Device: Nerivio sham deviceParticipants will treat with a sham (placebo) Nerivio device every other day for migraine prevention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years old.
- Must have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic (at least 15 days of Headache Days(HD)/ month with migraine days (migraine with or without aura) at least 8 days/ month for > 3 months) or non-chronic migraine.
- History of 6 to 24 headache days per 28-day period for each of the 3 months preceding study enrolment (based on participant report).
- Subject on prophylactic migraine treatment are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 2 months prior to the screening visit, and the dose is not expected to change during the course of the study.
- Have personal access to a smartphone (24/7).
Key exclusion criteria (8 listed)
- An active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Uncontrolled epilepsy.
- History of use of opioids or barbiturates on more than 4 days a month in the last 6 months.
- Current participation in any other interventional clinical study
- Subject without basic cognitive and motor skills required for operating a smartphone.
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 |
|---|---|---|
| Nerivio active deviceNerivio neurostimulator of conditional pain modulation (CPM) | Device | Migraine prevention treatment with active Nerivio |
| Nerivio sham deviceNerivio neurostimulator with an electrical output not intended for neurostimulation | Device | Migraine prevention treatment with sham Nerivio |
Primary outcome
Reduction in Migraine Days
Time frame: 3 months
The mean reduction in the number of migraine days per month during the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12) compare to the 4-week baseline phase (weeks 1 through 4) A migraine day is defined as a calendar day with a headache that is accompanied by at least one of the following symptoms: aura, photophobia, phonophobia, nausea and/or vomiting; or a calendar day with a headache that is treated with a migraine-specific acute medication.
Rate of Adverse Events (Safety and Tolerability)
Time frame: 3 months
Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and Device-related Adverse Events
5 secondary outcomes
Reduction in Moderate/Severe Headache Days
Time frame: 3 months
Reduction Headache Days
Time frame: 3 months
Reduction of 50% in Headache Days
Time frame: 3 months
Increase in Headache Impact Test-6 (HIT-6) Score at the End of the Last 28 Days (4 Weeks) of the Treatment Phase (Weeks 9 Through 12) Compare to the HIT-6 Score at the End of the 4-week Baseline Phase (Weeks 1 Through 4)
Time frame: 3 months
Reduction in Migraine-Specific Quality-of-Life (MSQ) Questionnaire Score at the End of the Last 28 Days (4 Weeks) of the Treatment Phase (Weeks 9 Through 12) Compare to the MSQ Score at the End of the 4-week Baseline Phase (Weeks 1 Through 4)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38028429Monteith TS, Stark-Inbar A, Shmuely S, Harris D, Garas S, Ironi A, Kalika P, Irwin SL. Remote electrical neuromodulation (REN) wearable device for adolescents with migraine: a real-world study of high-frequency abortive treatment suggests preventive effects. Front Pain Res (Lausanne). 2023 Nov 6;4:1247313. doi: 10.3389/fpain.2023.1247313. eCollection 2023.
- 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.
Robert Cowan, MD study chair
Stanford Health Care
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerivio active device in people with Migraine, run by Theranica at 16 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 7 inclusion and 8 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2023). 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?
Reduction in Migraine Days (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04828707, 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 15 Mar 2023.