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Randomized study of two digital therapeutics for the prevention of episodic migraine
The purpose of this randomized ReMMi-D trial is to evaluate the effectiveness and safety of two prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adolescents and adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults. |
|
| Arm B | Experimental | Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReMMi-D Digital Therapeutic | Device | Evaluate the effectiveness and safety of prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adults and adolescents. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MMD (Monthly Migraine Days) | Change in the number of MMDs from baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12). | Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Have at Least a 50% Reduction From Baseline | Participants who have at least a 50% reduction from baseline (28-day Run-in Period) in the number of MMDs to Week 12 (previous 28 days, Week 9 through Week 12) | Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12) |
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Inclusion Criteria:
A participant will be eligible for entry into the study if all of the following criteria are met:
Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
Lives in the United States.
Adult or late adolescent, 18 years of age or older at the time of informed consent.
Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
The following will be physician-reviewed: Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition.
Is currently managing migraines with ≥1 prescription acute treatment and/or prescription first or second-line preventive medications, as assessed by a physician.
Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or later or a smartphone with an Android operating system (OS) 11 or later and is willing to download and use the Study App required by the protocol.
Is willing and able to receive SMS text messages and push messages on their smartphone.
Is the owner of, and has regular access to, an email address.
Has regular access to the Internet via cellular data plan and/or wifi.
Exclusion Criteria:
A participant will not be eligible for study entry if any of the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Parth Shah | ObvioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42129417 | Derived | Lakhan SE, Petrova M, Snipes C, Kuka A, Peters-Strickland T, Besedina O, Taraboanta L, Livezey V, Speier A, Diamond M, Tepper SJ. Integrated analysis of two randomized controlled trials of a digital therapeutic for episodic migraine prevention. NPJ Digit Med. 2026 May 13. doi: 10.1038/s41746-026-02675-6. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (CT-132) | Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults. |
| FG001 | Arm B (Digital Control) | Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (CT-132) | Mobile application A (CT-132) as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults. |
| BG001 | Arm B (Digital Control) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in MMD (Monthly Migraine Days) | Change in the number of MMDs from baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12). | Intent-to-treat Population, all enrolled participants who were randomized, based on the assigned intervention in the randomization and recorded in the database. | Posted | Least Squares Mean | 95% Confidence Interval | migraine days per month | Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12) |
|
Baseline (28-day run-in period) through Week 12 (up to 16 weeks).
Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| peritonsillar abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development | Click Therapeutics | 347-460-8607 | click_ct_contact@clicktherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2024 | Jun 13, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2024 | Jun 13, 2025 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Double-blind
| Change From Baseline in the Number of MMD Recorded Over the Previous 28 Days at Week 4 and Week 8 |
Change from baseline (28-day Run-in Period) in the number of MMDs recorded over the previous 28 days at Week 4 and at Week 8 |
| Baseline (28-day Run-in Period) to Weeks 4 and 8 |
| Change From Baseline in the Mean Number of MMD Over 12 Weeks | Change from baseline (28-day Run-in Period) in the mean number of MMDs over 12 weeks. | Baseline (28-day Run-in Period) to Week 12 |
| Change in Number of Headaches With at Least Moderate Severity From Baseline to Week 12 | Change in the number of headaches with at least moderate severity from baseline (28-day run-in period) to Week 12 (previous 28 days, Week 9 through Week 12). | Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12) |
| Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) Total Score Over the Previous 28 Days at Week 4, Week 8, and Week 12 | Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12 The MSQ is a self-administered, 14-item instrument that is completed at baseline, Week 4, Week 8, and Week 12. Participants respond to items using a 6-point scale: "none of the time," "a little bit of the time," "some of the time," "a good bit of the time," "most of the time," and "all of the time," which are assigned scores of 1 to 6, respectively. Next, raw dimension scores are computed as a sum of recoded item scores and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life. | Baseline (28-day Run-in Period) to Weeks 4, 8 and 12. |
| Change From Baseline (28-day Run-in Period) in the Migraine Disability Assessment (MIDAS) to Week 12 (Previous 28 Days, Week 9 Through Week 12) | Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12 The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self report 5-item questionnaire (scale: 0 - 90 for each of 5 subscales) designed to quantify headache-related disability over a 3-month period. The 5 subscale scores are summed to compute the MIDAS total score (scale: 0 - 450). Lower scores indicate less headache-related disability. | Baseline to Weeks 4, 8, and 12 |
| Change From Baseline (28-day Run-in Period) to Week 12 (Previous 28 Days, Week 9 Through Week 12) in the Number of Migraines With Use of an Acute Migraine Medication | Change in the number of migraines with use of an acute migraine medications from the run-in period to Weeks 9-12. The number of migraines with use of an acute medication will be counted for the run-in period and for post randomization period. The change from baseline will be calculated as number of migraines in weeks 9-12 minus number of migraines in the run-in period with use of an acute medication. | Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12) |
| Change in the Number of Monthly Headache Days (MHDs) From Baseline to Week 12 | Change in the number of monthly headache days from baseline to Weeks 9-12 | Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12) |
Mobile application B (Digital Control) is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
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| Secondary | Participants Who Have at Least a 50% Reduction From Baseline | Participants who have at least a 50% reduction from baseline (28-day Run-in Period) in the number of MMDs to Week 12 (previous 28 days, Week 9 through Week 12) | Posted | Count of Participants | Participants | Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12) |
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| Secondary | Change From Baseline in the Number of MMD Recorded Over the Previous 28 Days at Week 4 and Week 8 | Change from baseline (28-day Run-in Period) in the number of MMDs recorded over the previous 28 days at Week 4 and at Week 8 | The overall number of participant analyzed present the number of participant with data at the time interval the assessment was complete (at week 4 and at week 8). | Posted | Mean | Standard Deviation | migraine days per month | Baseline (28-day Run-in Period) to Weeks 4 and 8 |
|
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| Secondary | Change From Baseline in the Mean Number of MMD Over 12 Weeks | Change from baseline (28-day Run-in Period) in the mean number of MMDs over 12 weeks. | Posted | Mean | Standard Deviation | migraine days per month | Baseline (28-day Run-in Period) to Week 12 |
|
|
|
| Secondary | Change in Number of Headaches With at Least Moderate Severity From Baseline to Week 12 | Change in the number of headaches with at least moderate severity from baseline (28-day run-in period) to Week 12 (previous 28 days, Week 9 through Week 12). | Posted | Mean | Standard Deviation | headaches | Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12) |
|
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| Secondary | Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) Total Score Over the Previous 28 Days at Week 4, Week 8, and Week 12 | Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12 The MSQ is a self-administered, 14-item instrument that is completed at baseline, Week 4, Week 8, and Week 12. Participants respond to items using a 6-point scale: "none of the time," "a little bit of the time," "some of the time," "a good bit of the time," "most of the time," and "all of the time," which are assigned scores of 1 to 6, respectively. Next, raw dimension scores are computed as a sum of recoded item scores and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life. | The overall number of participant analyzed present the number of participant with data at the time-interval the assessment was complete (at week 4, at week 8 and at week 12). | Posted | Mean | Standard Deviation | score on a scale | Baseline (28-day Run-in Period) to Weeks 4, 8 and 12. |
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| Secondary | Change From Baseline (28-day Run-in Period) in the Migraine Disability Assessment (MIDAS) to Week 12 (Previous 28 Days, Week 9 Through Week 12) | Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12 The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self report 5-item questionnaire (scale: 0 - 90 for each of 5 subscales) designed to quantify headache-related disability over a 3-month period. The 5 subscale scores are summed to compute the MIDAS total score (scale: 0 - 450). Lower scores indicate less headache-related disability. | The overall number of participant analyzed present the number of participant with data at the time interval the assessment was complete (at week 4, at week 8, and at week 12). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Weeks 4, 8, and 12 |
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| Secondary | Change From Baseline (28-day Run-in Period) to Week 12 (Previous 28 Days, Week 9 Through Week 12) in the Number of Migraines With Use of an Acute Migraine Medication | Change in the number of migraines with use of an acute migraine medications from the run-in period to Weeks 9-12. The number of migraines with use of an acute medication will be counted for the run-in period and for post randomization period. The change from baseline will be calculated as number of migraines in weeks 9-12 minus number of migraines in the run-in period with use of an acute medication. | Posted | Mean | Standard Deviation | migraine | Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12) |
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| Secondary | Change in the Number of Monthly Headache Days (MHDs) From Baseline to Week 12 | Change in the number of monthly headache days from baseline to Weeks 9-12 | Posted | Mean | Standard Deviation | headache days per month | Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12) |
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|
| 0 |
| 278 |
| 1 |
| 278 |
| 22 |
| 278 |
| EG001 | Arm B | Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine. | 0 | 278 | 0 | 278 | 16 | 278 |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Procedural pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Mastitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Peritonsillar abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Abdominal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Cartilage injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Animal bite | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Status migrainosus | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Depressive symptom | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Panic attack | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hysterosalpingo-oophorectomy | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
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| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Change from Baseline at Week 8 |
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| Change from Baseline to Week 8 |
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| Change from Baseline to Week 12 |
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| Change from Baseline at Week 8 |
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| Change from Baseline at Week 12 |
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