MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)

Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.

Time frame: Baseline and Week 12

Population: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.

Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.

Time frame: Baseline and Week 12

Population: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.

Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.

Time frame: up to 14 days after last dose of study drug (up to 12 weeks)

Population: All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.

Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.

Time frame: up to 12 weeks

Population: All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.

Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.

Time frame: Baseline and Week 12

Population: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.

Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.

Time frame: Baseline and Week 12

Population: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.

Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized

Time frame: Week 12

Population: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.