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Study of Two Digital Therapeutics for the Prevention of Episodic Migraine (ReMMi-D)

Primary Purpose

Migraine, Episodic Migraine, Headache

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ReMMi-D Digital Therapeutic
Sponsored by
Click Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Age of onset of migraines prior to 50 years of age Migraine attacks, on average, lasting 4-72 hours if untreated Per participant report, 4-14 migraine days per month within the last 3 months prior to the Screening Visit (a month is defined as 28 days) Four to fourteen migraine days during the run-in period 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: History of basilar migraine or hemiplegic migraine. Active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or complex regional pain syndrome (CRPS). Other pain syndromes (including trigeminal neuralgia), psychiatric conditions (such as major depressive episode, bipolar disorder, major depressive disorder, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months (48 weeks) or having met DSM-V criteria for any significant substance use disorder within the past 12 months (48 weeks) from the date of the screening visit. History of use of analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen, including opioids) or butalbital on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit or during the run-in period. Currently taking a prescription anti-calcitonin gene-related peptide (CGRP) for either episodic or chronic migraine. Post-traumatic headache, persistent post-traumatic headache, or post-concussion syndrome. Other significant episodic or chronic medical condition(s) that in the opinion of the Investigator, may confound the interpretation of findings to inform PDT development. Failure to adhere with or inability to complete Study App inputs and onboarding activities during the run-in period. Participants who are not adherent during the run-in period are not eligible for study entry. Previous enrollment in any digital therapeutics pilot or pivotal study for a migraine indication. Participation in any other investigational clinical study while participating in this clinical study.

Sites / Locations

  • Click TherapeuticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.

Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.

Outcomes

Primary Outcome Measures

Change in MMD (monthly migraine days)
Change from baseline in the number of Monthly Migraine Days (MMD) at Week 12 of intervention

Secondary Outcome Measures

Proportion of Patients with Decrease in MMD
Proportion of participants who have at least a 50% reduction from baseline in the mean number of MMD at Week 12
Decrease in MMD
Change from baseline in the number of MMD recorded over the previous 28 days at Week 4 and Week 8
Decrease in MMD
Change from baseline in the mean number of MMD over 12 weeks
Change in average headache severity
Change in the average severity of headache from the run-in period to Weeks 9-12 assessed by Likert-type scale of 1-3 in severity
Change in MSQ
Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12
Change in MIDAS
Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12
Change in frequency of Migraine Medications
Change in the frequency used of acute migraine medications from the run-in period to Weeks 9-12
Change in dose of Migraine Medications
Change in the dose of acute migraine medications from the run-in period to Weeks 9-12
Change in type of Migraine Medications
Change in the type of acute migraine medications from the run-in period to Weeks 9-12

Full Information

First Posted
April 18, 2023
Last Updated
May 10, 2023
Sponsor
Click Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05853900
Brief Title
Study of Two Digital Therapeutics for the Prevention of Episodic Migraine
Acronym
ReMMi-D
Official Title
A Randomized Double-blind, Parallel-Group, Virtual Study to Evaluate the Efficacy and Safety of Two Digital Therapeutics in Late Adolescents and Adults for the Prevention of Episodic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
September 18, 2023 (Anticipated)
Study Completion Date
October 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Click Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized study of two digital therapeutics for the prevention of episodic migraine
Detailed Description
The purpose of this randomized ReMMi-D trial is to evaluate the efficacy 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Episodic Migraine, Headache, Headache, Migraine
Keywords
Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
558 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Intervention Type
Device
Intervention Name(s)
ReMMi-D Digital Therapeutic
Intervention Description
Evaluate the efficacy 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.
Primary Outcome Measure Information:
Title
Change in MMD (monthly migraine days)
Description
Change from baseline in the number of Monthly Migraine Days (MMD) at Week 12 of intervention
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Proportion of Patients with Decrease in MMD
Description
Proportion of participants who have at least a 50% reduction from baseline in the mean number of MMD at Week 12
Time Frame
Baseline to Week 12
Title
Decrease in MMD
Description
Change from baseline in the number of MMD recorded over the previous 28 days at Week 4 and Week 8
Time Frame
Baseline to Weeks 4 and 8
Title
Decrease in MMD
Description
Change from baseline in the mean number of MMD over 12 weeks
Time Frame
Baseline to Week 12
Title
Change in average headache severity
Description
Change in the average severity of headache from the run-in period to Weeks 9-12 assessed by Likert-type scale of 1-3 in severity
Time Frame
Run-in to Weeks 9-12
Title
Change in MSQ
Description
Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12
Time Frame
Baseline to Weeks 4, 8 and 12
Title
Change in MIDAS
Description
Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12
Time Frame
Baseline to Weeks 4, 8, and 12
Title
Change in frequency of Migraine Medications
Description
Change in the frequency used of acute migraine medications from the run-in period to Weeks 9-12
Time Frame
Run-in to Weeks 9-12
Title
Change in dose of Migraine Medications
Description
Change in the dose of acute migraine medications from the run-in period to Weeks 9-12
Time Frame
Run-in to Weeks 9-12
Title
Change in type of Migraine Medications
Description
Change in the type of acute migraine medications from the run-in period to Weeks 9-12
Time Frame
Run-in to Weeks 9-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Age of onset of migraines prior to 50 years of age Migraine attacks, on average, lasting 4-72 hours if untreated Per participant report, 4-14 migraine days per month within the last 3 months prior to the Screening Visit (a month is defined as 28 days) Four to fourteen migraine days during the run-in period 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: History of basilar migraine or hemiplegic migraine. Active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or complex regional pain syndrome (CRPS). Other pain syndromes (including trigeminal neuralgia), psychiatric conditions (such as major depressive episode, bipolar disorder, major depressive disorder, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months (48 weeks) or having met DSM-V criteria for any significant substance use disorder within the past 12 months (48 weeks) from the date of the screening visit. History of use of analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen, including opioids) or butalbital on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit or during the run-in period. Currently taking a prescription anti-calcitonin gene-related peptide (CGRP) for either episodic or chronic migraine. Post-traumatic headache, persistent post-traumatic headache, or post-concussion syndrome. Other significant episodic or chronic medical condition(s) that in the opinion of the Investigator, may confound the interpretation of findings to inform PDT development. Failure to adhere with or inability to complete Study App inputs and onboarding activities during the run-in period. Participants who are not adherent during the run-in period are not eligible for study entry. Previous enrollment in any digital therapeutics pilot or pivotal study for a migraine indication. Participation in any other investigational clinical study while participating in this clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
8773525425
Email
researchcoordinator@clicktherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parth Shah
Organizational Affiliation
ObvioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Click Therapeutics
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
877-352-5425
Email
researchcoordinator@clicktherapeutics.com

12. IPD Sharing Statement

Learn more about this trial

Study of Two Digital Therapeutics for the Prevention of Episodic Migraine

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