Migraine
Conditions
Keywords
Migraine, Episodic migraine, Chronic migraine, Atogepant, Topiramine, QULIPTA, Migraine prophylaxis
Brief summary
A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
Interventions
DRUGAtogepant
Oral Tablet
Oral Tablet
DRUGTopiramate
Oral Capsule
DRUGPlacebo for Topiramate
Oral Capsule
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Documented history of migraine (with or without aura) for \>= 12 months prior to screening (Visit 1). * History of \>= 4 migraine days per month who require preventive treatment of migraine and are eligible for conventional migraine prophylaxis.
Exclusion criteria
* Have used topiramate or atogepant in the past. * Have clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Discontinued Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | Week 24 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events (TEAEs) are defined as any AE with an onset date on or after the date of first dose of study drug during the Double Blind (DB) treatment period; and on or before the date of last dose of study drug during the DB treatment period (including tapering off phase, if applicable) + 30 days; and before the date of first dose of study drug during the Open Label (OL) treatment period, if applicable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving ≥ 50% Improvement (Reduction) in Mean Monthly Migraine Days (MMD) During Months 4 to 6 (DB Period) | Months 4 to 6 (DB Period) | The mean monthly migraine days across Months 4 to 6 is calculated by taking the 3-month average of monthly migraine days over Months 4 to 6. The monthly migraine days is defined as the total number of recorded migraine days in the eDiary divided by the total number of days with eDiary records during each monthly period and multiplied by 28. The responder status of 50% reduction from Baseline is defined as a participant with at least a 50% reduction from Baseline in the 3-month average of monthly migraine days over Months 4 to 6. |
| Change From Baseline in Mean Monthly Migraine Days During Months 4 to 6 (DB Period) | Baseline to Month 4 to Month 6 (DB Period) | The mean monthly migraine days across Months 4 to 6 is calculated by taking the 3-month average of monthly migraine days over Months 4 to 6. The monthly migraine days is defined as the total number of recorded migraine days in the eDiary divided by the total number of days with eDiary records during each monthly period and multiplied by 28. |
| Change From Baseline in the Total 6-Item Headache Impact Test (HIT-6) Score at Week 24 | Baseline to Week 24 | The HIT-6 is a 6-item assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home and in social situations. It assesses the effect that headaches have on normal daily life and the subject's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses, each of which is assigned a score ranging from 6 points (never) to 13 points (always). Negative changes from Baseline in the HIT-6 score indicate improvement. |
| Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Week 24 | Baseline to Week 24 | MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: Role Function Restrictive, Role Function Preventive, and Emotional Function domain. Participants respond to items using a 6-point scale ranging from "none of the time" to "all of the time." Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. |
| Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Assessed by the Patient Global Impression of Change (PGIC) | Week 24 | The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Since you started the study treatment, how would you rate the change in your overall condition?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome. |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Subset - Short Form 6a Version 2.0 Score | Baseline to Week 6 | The Patient Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function and Cognitive Function Abilities Subset item banks assess patient perceived cognitive deficits (i.e., mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes) over the past 7 days. A 5-level response scale for all 6 items ranges from 1 (Not at all) to 5 (Very much). The raw score of PROMIS-CF is the sum of all 6 items, ranging from 6 to 30. The raw score is standardized into a T-score with a mean of 50 and standard deviation of 10. Higher scores indicate a better cognitive function. |
Countries
Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Portugal, United Kingdom
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 12.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 261 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 522 Participants |
| Sex: Female, Male Female | 484 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 272 | 0 / 273 | 0 / 457 |
| other Total, other adverse events | 189 / 272 | 154 / 273 | 61 / 457 |
| serious Total, serious adverse events | 3 / 272 | 7 / 273 | 8 / 457 |
Outcome results
None listed