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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
568
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.
Click Therapeutics
New York, New York, United States
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).
Time frame: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)
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)
Time frame: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)
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
Time frame: 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.
Time frame: 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).
Time frame: 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
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)