Randomized study of two digital therapeutics for the prevention of episodic migraine in patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
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
Click Therapeutics
New York, New York, United States
Change in Monthly Migraine Days (MMDs)
Change from baseline in the number of Monthly Migraine Days (MMDs) at Week 12
Time frame: Baseline to Week 12
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
Time frame: Baseline to 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
Time frame: Baseline to Weeks 4 and 8
Change in Mean MMDs
Reduction from baseline in the mean number of MMDs over 12 weeks
Time frame: Baseline to Week 12
Change in Average Headache Severity
Change in the average severity of headache from the run-in period to Weeks 9-12
Time frame: Run-in 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
Time frame: Baseline to Weeks 4, 8 and 12
Change in Migraine Disability Assessment (MIDAS)
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
Change in Migraine Medication Use (frequency)
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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
Change in Migraine Medication Use (dose)
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
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
Time frame: Run-in to Weeks 9-12