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Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)

Primary Purpose

Migraine, Episodic Migraine, Headache

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Click 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, CGRP, Calcitonin Gene-Related Peptide Inhibitor Therapy

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 per participant self-report: 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 at the time of informed consent. Able to read and understand the English informed consent form. The following will be investigator-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 (ICHD), 3rd Edition: i. Age of onset of migraines prior to 50 years of age ii. Migraine attacks, on average, lasting 4-72 hours if untreated iii. Per participant report, 4 or more migraine days per month within the last 3 months prior to the Screening Visit (a month is defined as 28 days) iv. Four to fourteen migraine days during the run-in period Is currently managing migraines with at least 1 prescription CGRP inhibitor therapy for the preventive or acute treatment of episodic or chronic migraine during the 3 months prior to screening. 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 specified eDiary and 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. Understands the use of and interest in the eDiary and the Study App during the screening period and the baseline visit (Day 1). Exclusion Criteria: A participant will not be eligible for study entry if any of the following criteria are met per participant self-report: 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 current 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-5 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. Post-traumatic headache, persistent post-traumatic headache, or post-concussion syndrome. Other significant acute 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 eDiary 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

Sites / Locations

  • Click TherapeuticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ReMMiD-C Therapeutic Arm A

ReMMiD-C Therapeutic Arm B

Arm Description

Mobile application A (ReMMiD-C Digital Therapeutic) as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.

Mobile application B as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.

Outcomes

Primary Outcome Measures

Change in Monthly Migraine Days (MMDs)
Change from baseline in the number of Monthly Migraine Days (MMDs) at Week 12

Secondary Outcome Measures

Proportion of Patients with Decrease in MMDs
Proportion of participants who have at least a 50% reduction from baseline in the mean number of MMDs at Week 12
Change in MMDs at Weeks 4 and 8
Change from baseline in the number of MMDs recorded over the previous 28 days at Week 4 and Week 8
Change in Mean MMDs
Reduction from baseline in the mean number of MMDs over 12 weeks
Change in Average Headache Severity
Change in the average severity of headache from the run-in period to Weeks 9-12
Change in Migraine Questionnaire
Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12
Change in Migraine Disability Assessment (MIDAS)
Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12
Change in Migraine Medication Use (frequency)
Change in the use (frequency) of acute migraine medications from the run-in period to Weeks 9-12
Change in Migraine Medication Use (dose)
Change in the use (dose) of acute migraine medications from the run-in period to Weeks 9-12
Change in Migraine Medication Use (medication type)
Change in the use (type) of acute migraine medications from the run-in period to Weeks 9-12

Full Information

First Posted
July 26, 2023
Last Updated
August 15, 2023
Sponsor
Click Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06004388
Brief Title
Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)
Official Title
A Randomized, Double-Blind, Parallel-Group, Virtual Study to Evaluate the Efficacy and Safety of Two Prescription Digital Therapeutics for the Prevention of Episodic Migraine in Late Adolescents and Adults Currently Receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
January 21, 2024 (Anticipated)
Study Completion Date
February 21, 2024 (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 in patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
Detailed Description
The purpose of this randomized 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 who are receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.

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, CGRP, Calcitonin Gene-Related Peptide Inhibitor Therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ReMMiD-C Therapeutic Arm A
Arm Type
Experimental
Arm Description
Mobile application A (ReMMiD-C Digital Therapeutic) as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.
Arm Title
ReMMiD-C Therapeutic Arm B
Arm Type
Experimental
Arm Description
Mobile application B as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.
Intervention Type
Device
Intervention Name(s)
Click 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 receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
Primary Outcome Measure Information:
Title
Change in Monthly Migraine Days (MMDs)
Description
Change from baseline in the number of Monthly Migraine Days (MMDs) at Week 12
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Proportion of Patients with Decrease in MMDs
Description
Proportion of participants who have at least a 50% reduction from baseline in the mean number of MMDs at Week 12
Time Frame
Baseline to Week 12
Title
Change in MMDs at Weeks 4 and 8
Description
Change from baseline in the number of MMDs recorded over the previous 28 days at Week 4 and Week 8
Time Frame
Baseline to Weeks 4 and 8
Title
Change in Mean MMDs
Description
Reduction from baseline in the mean number of MMDs 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
Time Frame
Run-in to Weeks 9-12
Title
Change in Migraine Questionnaire
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 Migraine Disability Assessment (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 Migraine Medication Use (frequency)
Description
Change in the use (frequency) of acute migraine medications from the run-in period to Weeks 9-12
Time Frame
Run-in to Weeks 9-12
Title
Change in Migraine Medication Use (dose)
Description
Change in the use (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 Migraine Medication Use (medication type)
Description
Change in the use (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 per participant self-report: 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 at the time of informed consent. Able to read and understand the English informed consent form. The following will be investigator-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 (ICHD), 3rd Edition: i. Age of onset of migraines prior to 50 years of age ii. Migraine attacks, on average, lasting 4-72 hours if untreated iii. Per participant report, 4 or more migraine days per month within the last 3 months prior to the Screening Visit (a month is defined as 28 days) iv. Four to fourteen migraine days during the run-in period Is currently managing migraines with at least 1 prescription CGRP inhibitor therapy for the preventive or acute treatment of episodic or chronic migraine during the 3 months prior to screening. 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 specified eDiary and 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. Understands the use of and interest in the eDiary and the Study App during the screening period and the baseline visit (Day 1). Exclusion Criteria: A participant will not be eligible for study entry if any of the following criteria are met per participant self-report: 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 current 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-5 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. Post-traumatic headache, persistent post-traumatic headache, or post-concussion syndrome. Other significant acute 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 eDiary 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
877-352-5425
Email
researchcoordinator@clicktherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaheen Lakhan
Organizational Affiliation
Click Therapeutics
Official's Role
Study Director
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 Receiving CGRP Therapy (ReMMiD-C)

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