This is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different dosages (30 IU daily and 60 IU daily) of TNX-1900 in patients with chronic migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
88
Patients will spray TNX-1900 once into each nostril.
Patients will spray placebo nasal spray once into each nostril.
Mean Change in the Number of Monthly Migraine Headache Days
Mean change in the number of monthly migraine headache days from the last 28 days of Baseline to the last 28 days of treatment (ie, month 3). A migraine headache day is any calendar day (0:00 to 23:59) in which the patient records in the e-diary: * An attack lasting 4 hours or more and meeting the ICHD-3 criteria for migraine without aura, or * A migraine with aura, or * An attack that meets ICHD-3 criteria for probable migraine, (a migraine subtype fulfilling all but one criteria (B-D) for migraine without aura), or * An attack of any duration that was believed by the patient to be a migraine and was relieved by a triptan, ergot derivative, or other migraine-specific abortive medication.
Time frame: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days
Proportion of patients experiencing a ≥ 50% reduction in the number of migraine headache days from the last 28 days of Baseline to the last 28 days of treatment in each treatment group
Time frame: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
Mean Change in the Number of Days Using Rescue Medication
Mean change in the number of days using rescue medication (triptan, ergot derivative, or other migraine-specific acute medication) from the last 28 days of Baseline to the last 28 days of treatment.
Time frame: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
Patient Global Impression of Change (PGIC)
Proportion of patients with a Patient Global Impression of Change (PGIC) of 1, "very much improved", or 2, "much improved", at Week 12. Scores range from 1 to 7. Lower scores indicate more improvement.
Time frame: Visit 5 (Week 12)
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Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Synergy Research Centers - Synergy San Diego
Lemon Grove, California, United States
Excell Research
Oceanside, California, United States
Viking Clinical Research, LTD
Temecula, California, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Segal Trials - Miami Lakes Medical Research Outpatient Site
Miami Lakes, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Diamond Headache Clinic
Chicago, Illinois, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
Alliance for Multispecialty Research - Wichita West
Wichita, Kansas, United States
...and 16 more locations
Mean Change in the Number of Moderate or Severe Headache Days
Mean change in the number of moderate or severe headache days from the last 28 days of Baseline to the last 28 days of treatment. A moderate or severe headache day is defined as any calendar day wherein a patient records a headache or migraine of moderate or severe peak intensity in the e-diary.
Time frame: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Mean Change in the Number of Migraine Headache Days
Mean change in the number of migraine headache days from the last 28 days of Baseline to average number per 28 days over the entire 12-week duration of Treatment Period.
Time frame: Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire
Mean change from Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) at Week 12. Scores range from 0 to 100. Higher scores indicate better quality of life.
Time frame: Visit 2 (Day 1) and Visit 5 (Week 12)