Trial Outcomes & Findings for Prevention Study in Adult Patients Suffering From Migraine Headaches (NCT NCT00742209)

There were 3 subjects who were randomized but did not take investigational product, and, therefore, were not included in the Safety, Intent to Treat (ITT), or Per Protocol (PP) population.

Prevention Study in Adult Patients Suffering From Migraine Headaches

A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary.

The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary.

The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary.

The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary.

The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary.

The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack.

A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures.

The PGIC is a single question measured on the 7-point Likert Scale (1 = "very much improved"; 2 = "much improved"; 7 = "very much worse"). A responder is defined as being "very much improved" or "much improved."

The CGIC is a single question measured on a 7-point Likert Scale. (1 = "very much improved"; 2= "much improved, and 7 = "very much worse") designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'.

The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status.

The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life.

Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant.

Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting "Very Satisfied" (scale value = 1) or "Satisfied" (scale value = 2) on the scale.