MigraineNCT05523310
Observational Study to Assess Migraine Prediction Tool
An observational study of Migraine, run by Theranica at 3 sites in United States.
Trial summary
This is a prospective, observational study. The participant will be required to approve his/her participation in the study by completing the electronic consent form. Data collected within the first eight weeks (weeks 1-8) will be used to develop the prediction models (either personal or population/group models). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine
- What is being tested?
- Daily questionnaire
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2030to 15 Nov 2030
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population consists of migraineurs who have already used Nerivio and its mobile application prior to joining the study and those who have not, with a target ratio of 50:50 (and up to 30:70 or 70:30) between these two subject types
Who may be able to join
- Subject age 18-75 years.
- Subject has migraine diagnosis for over 6 months prior to enrolling to the study.
- Subject has 4-24 headache days per month.
- Subject has a Nerivio user account, or willing to create a Nerivio user account to participate in the study.
- Subject is willing to sign an Informed Consent Form.
Who cannot join
- NA
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nuvance Health Vassar Medical Center
Poughkeepsie, New York, 12601
Headache Neurology Research Institute
Ridgeland, Mississippi, 39157
Westport Headache Institute
Westport, Connecticut, 06880
About this study
Official title: Prospective, Observational Study to Assess Migraine Prediction Tool Based on Prodromal Symptoms and Additional Parameters
This is a prospective, observational study. The participant will be required to approve his/her participation in the study by completing the electronic consent form. Data collected within the first eight weeks (weeks 1-8) will be used to develop the prediction models (either personal or population/group models). The developed algorithm will be freezer and tested against the data collected during weeks 1-8 of a different cohort population
Read the detailed description
Migraine treatment may be acute (abortive) or preventive (prophylactic), with patients often requiring both. The objectives of acute treatment are to treat attacks early; to achieve quick pain relief; to minimize or eliminate adverse events; to restore function; to decrease recurrence and the need for rescue treatment; and to reduce medical resource use. Preventive treatment is aimed to lower the frequency, intensity, and duration of the attacks.
In general, a prodrome is an early sign or symptom (or set of signs and symptoms) that often indicates the onset of a disease before more diagnostically specific signs and symptoms develop. Prodromal or premonitory symptoms occur in about 60% of those with migraines, with an onset that can range from two hours to two days before the start of pain or the aura. These symptoms may include a wide variety of phenomena including altered mood, irritability, depression or euphoria, fatigue, craving for certain food(s), stiff muscles (especially in the neck), constipation or diarrhea, and sensitivity to smells or noise. This may occur in those with either migraine with aura or migraine without aura. Neuroimaging indicates the limbic system and hypothalamus as the origin of prodromal symptoms in migraine.
Robust prediction of migraine attacks could lead to pre-emptive treatment, provide patients with opportunities to plan for impending attacks, reduce interictal anxiety, and improve self-efficacy among other benefits.
This study aims to develop and evaluate the effectiveness of a migraine prediction tool based on early prodromal (pre-migraine) symptoms, that may enhance the acute treatment of migraine
Prior enrollment, Informed consent must be obtained from each participant before any protocol-related activities are performed. Participants will receive a daily notification (through an app notification) with a link to the daily questionnaire. The app may collect other data items, related to the specific location of every participant, such as weather, air quality, etc.
The primary outcome measure is the presence of headache attack occurring over the 24-hour period recorded following a daily diary entry.
During the development phase, 100% of the data will be used for developing and training the prediction model. Once the model will be ready, it will be "freezer" and used over a different cohort population to validate the prediction model. The AUC of the prediction model will be assessed to validate the accuracy (Specificity vs. Sensitivity) of the prediction model.
The study will include the development of a general predictive model for the study population, with adjustments to individual participants, forecasting the probability of experiencing a headache and/or aura phase of a migraine attack during a particular interval. The outcome measure performance of this model using the Area Under the Curve (AUC) metric. The AUC model measures how often the algorithm predicts a higher probability for a migraine over non-migraine.
- Conditions
- Migraine
- Being tested
- Daily questionnaire
- Keywords
- Migraine prediction, Migraine prodrome, Migraine prevention
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily questionnaireOther
All patients will be asked to complete a daily questionnaire regarding their migraine, medications, and prodromal symptoms during that day
| Study group | Role | What they receive |
|---|---|---|
| Training group | The training group will be used to develop the prediction model, based on their reported daily questionnaire. Participants in the training group will not be included in the Validation group Receives: Other: Daily questionnaire | |
| Validation group | The validation group will be used only for validation (test) of the prediction model ("Naïve group"). Participants in the validation group could not be recruited from the training group Receives: Other: Daily questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of an effective algorithm and software to predict migraine attacks.
The primary endpoint will be the Predivio's prediction model sensitivity and specificity, presented by receiver operating characteristic (ROC) analysis using the Area Under the Curve (AUC) within the validation cohort population
Measured: Predication period of 24 hours prior headache
Secondary outcomes (2)
Predivio accuracy
Predivio's accuracy will be evaluated by the sensitivity and specificity, presented by the Area Under the Curve (AUC) within the validation cohort population
Measured: Predication period of 24 hours prior headache
Predivio's percent of participants for whom the sensitivity and specificity are at least 80%.
Predivio's percent of participants will be evaluated by the sensitivity and specificity of at least 80% within the validation cohort population
Measured: Predication period of 24 hours prior headache
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Jan 2030 (estimated)
- Primary completion1 Oct 2030 (estimated)
- Study completion15 Nov 2030 (estimated)
Why it stopped: The Sponsor decided to cancel the study due to commercial considerations
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523310
- Sponsor's protocol ID
- TCH010
- Status last verified
- Oct 2024
- First submitted
- 29 Aug 2022
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study to Assess Migraine Prediction Tool Based on Prodromal Symptoms and Additional Parameters
- ClinicalTrials.gov ID
- NCT05523310
- Acronym / sponsor ID
- TCH010
- Conditions
- Migraine
- Keywords
- Migraine prediction, Migraine prodrome, Migraine prevention
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: The Sponsor decided to cancel the study due to commercial considerations
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2030 (estimated)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 15 Nov 2030 (estimated)
- First posted
- 31 Aug 2022 (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.
This is a prospective, observational study. The participant will be required to approve his/her participation in the study by completing the electronic consent form. Data collected within the first eight weeks (weeks 1-8) will be used to develop the prediction models (either personal or population/group models). The developed algorithm will be freezer and tested against the data collected during weeks 1-8 of a different cohort population
Detailed description
Migraine treatment may be acute (abortive) or preventive (prophylactic), with patients often requiring both. The objectives of acute treatment are to treat attacks early; to achieve quick pain relief; to minimize or eliminate adverse events; to restore function; to decrease recurrence and the need for rescue treatment; and to reduce medical resource use. Preventive treatment is aimed to lower the frequency, intensity, and duration of the attacks.
In general, a prodrome is an early sign or symptom (or set of signs and symptoms) that often indicates the onset of a disease before more diagnostically specific signs and symptoms develop. Prodromal or premonitory symptoms occur in about 60% of those with migraines, with an onset that can range from two hours to two days before the start of pain or the aura. These symptoms may include a wide variety of phenomena including altered mood, irritability, depression or euphoria, fatigue, craving for certain food(s), stiff muscles (especially in the neck), constipation or diarrhea, and sensitivity to smells or noise. This may occur in those with either migraine with aura or migraine without aura. Neuroimaging indicates the limbic system and hypothalamus as the origin of prodromal symptoms in migraine.
Robust prediction of migraine attacks could lead to pre-emptive treatment, provide patients with opportunities to plan for impending attacks, reduce interictal anxiety, and improve self-efficacy among other benefits.
This study aims to develop and evaluate the effectiveness of a migraine prediction tool based on early prodromal (pre-migraine) symptoms, that may enhance the acute treatment of migraine
Prior enrollment, Informed consent must be obtained from each participant before any protocol-related activities are performed. Participants will receive a daily notification (through an app notification) with a link to the daily questionnaire. The app may collect other data items, related to the specific location of every participant, such as weather, air quality, etc.
The primary outcome measure is the presence of headache attack occurring over the 24-hour period recorded following a daily diary entry.
During the development phase, 100% of the data will be used for developing and training the prediction model. Once the model will be ready, it will be "freezer" and used over a different cohort population to validate the prediction model. The AUC of the prediction model will be assessed to validate the accuracy (Specificity vs. Sensitivity) of the prediction model.
The study will include the development of a general predictive model for the study population, with adjustments to individual participants, forecasting the probability of experiencing a headache and/or aura phase of a migraine attack during a particular interval. The outcome measure performance of this model using the Area Under the Curve (AUC) metric. The AUC model measures how often the algorithm predicts a higher probability for a migraine over non-migraine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | – | Other: Daily questionnaireThe training group will be used to develop the prediction model, based on their reported daily questionnaire. Participants in the training group will not be included in the Validation group |
| Validation group | – | Other: Daily questionnaireThe validation group will be used only for validation (test) of the prediction model ("Naïve group"). Participants in the validation group could not be recruited from the training group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population consists of migraineurs who have already used Nerivio and its mobile application prior to joining the study and those who have not, with a target ratio of 50:50 (and up to 30:70 or 70:30) between these two subject types
Key inclusion criteria (5 listed)
- Subject age 18-75 years.
- Subject has migraine diagnosis for over 6 months prior to enrolling to the study.
- Subject has 4-24 headache days per month.
- Subject has a Nerivio user account, or willing to create a Nerivio user account to participate in the study.
- Subject is willing to sign an Informed Consent Form.
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Daily questionnaireAll patients will be asked to complete a daily questionnaire regarding their migraine, medications, and prodromal symptoms during that day | Other | Training group, Validation group |
Primary outcome
Validation of an effective algorithm and software to predict migraine attacks.
Time frame: Predication period of 24 hours prior headache
The primary endpoint will be the Predivio's prediction model sensitivity and specificity, presented by receiver operating characteristic (ROC) analysis using the Area Under the Curve (AUC) within the validation cohort population
2 secondary outcomes
Predivio accuracy
Time frame: Predication period of 24 hours prior headache
Predivio's percent of participants for whom the sensitivity and specificity are at least 80%.
Time frame: Predication period of 24 hours prior headache
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Theranica at 3 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 5 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: paused, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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?
Validation of an effective algorithm and software to predict migraine attacks. (time frame: Predication period of 24 hours prior headache). 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 22 Nov 2024.