Trial Outcomes & Findings for A Study of the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Participants With Episodic Migraine (MK-6096-020) (NCT NCT01513291)

Results Overview

Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Change in the mean monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly migraine days.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

237 participants

Primary outcome timeframe

Baseline and average over Treatment Period (Weeks 0-12)

Results posted on

2018-11-07

Participant Flow

A total of 423 participants were screened. Of these, 237 participants completed screening and met the eligibility criteria, including the required number of migraine days during the Screening period.

Participant milestones

Participant milestones
Measure	Treatment Period: MK-6096 Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period	Treatment Period: Placebo Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period	Run-out Period: MK-6096 / MK-6096 Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: MK-6096 / Placebo Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: Placebo / Placebo Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
Treatment Period STARTED	120	117	0	0	0
Treatment Period Treated	120	115	0	0	0
Treatment Period COMPLETED	97	101	0	0	0
Treatment Period NOT COMPLETED	23	16	0	0	0
Run-out Period STARTED	0	0	50	47	101
Run-out Period COMPLETED	0	0	50	45	101
Run-out Period NOT COMPLETED	0	0	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Period: MK-6096 Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period	Treatment Period: Placebo Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period	Run-out Period: MK-6096 / Placebo Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
Treatment Period Adverse Event	8	4	0
Treatment Period Lack of Efficacy	3	0	0
Treatment Period Lost to Follow-up	2	3	0
Treatment Period Physician Decision	1	0	0
Treatment Period Protocol Violation	1	2	0
Treatment Period Withdrawal by Subject	8	5	0
Treatment Period Randomized not treated	0	2	0
Run-out Period Lost to Follow-up	0	0	1
Run-out Period Withdrawal by Subject	0	0	1

Baseline Characteristics

A Study of the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Participants With Episodic Migraine (MK-6096-020)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Period: MK-6096 n=120 Participants Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period	Treatment Period: Placebo n=117 Participants Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period	Total n=237 Participants Total of all reporting groups
Age, Continuous	42.5 Years STANDARD_DEVIATION 10.7 • n=5 Participants	41.9 Years STANDARD_DEVIATION 11.3 • n=7 Participants	42.2 Years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	99 Participants n=7 Participants	201 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and average over Treatment Period (Weeks 0-12)

Population: The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.

Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Change in the mean monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly migraine days.

Outcome measures

Outcome measures
Measure	Treatment Period: MK-6096 n=120 Participants Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period	Treatment Period: Placebo n=114 Participants Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period	Run-out Period: MK-6096 / MK-6096 Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: MK-6096 / Placebo Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: Placebo / Placebo Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
Mean Change From Baseline in Monthly Migraine Days Baseline	8.2 Days/month Standard Error 0.1	8.2 Days/month Standard Error 0.1	—	—	—
Mean Change From Baseline in Monthly Migraine Days Change from Baseline	-1.7 Days/month Standard Error 0.3	-1.3 Days/month Standard Error 0.3	—	—	—

PRIMARY outcome

Timeframe: Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14

Population: The population analyzed included all randomized participants who received at least one dose of double-blind study treatment.

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 sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.

Outcome measures

Outcome measures
Measure	Treatment Period: MK-6096 n=120 Participants Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period	Treatment Period: Placebo n=115 Participants Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period	Run-out Period: MK-6096 / MK-6096 n=50 Participants Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: MK-6096 / Placebo n=47 Participants Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: Placebo / Placebo n=101 Participants Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
Percentage of Participants With One or More Adverse Events	46.7 Percentage of participants	37.4 Percentage of participants	10.0 Percentage of participants	17.0 Percentage of participants	7.9 Percentage of participants

PRIMARY outcome

Timeframe: Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14

Population: The population analyzed included all randomized participants who received at least one dose of double-blind study treatment.

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 sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.

Outcome measures

Outcome measures
Measure	Treatment Period: MK-6096 n=120 Participants Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period	Treatment Period: Placebo n=115 Participants Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period	Run-out Period: MK-6096 / MK-6096 n=50 Participants Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: MK-6096 / Placebo n=47 Participants Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: Placebo / Placebo n=101 Participants Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
Percentage of Participants Discontinued From Study Medication Due to an Adverse Event	6.7 Percentage of participants	4.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and average over Treatment Period (Weeks 0-12)

Population: The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.

Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A headache was defined as headache pain of at least 30 minutes duration or for any duration for which headache treatment was administered. Change in the mean monthly headache days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly headache days.

Outcome measures

Outcome measures
Measure	Treatment Period: MK-6096 n=120 Participants Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period	Treatment Period: Placebo n=114 Participants Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period	Run-out Period: MK-6096 / MK-6096 Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: MK-6096 / Placebo Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: Placebo / Placebo Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
Mean Change From Baseline in Monthly Headache Days Baseline	9.6 Days/month Standard Error 0.2	9.6 Days/month Standard Error 0.2	—	—	—
Mean Change From Baseline in Monthly Headache Days Change from Baseline	-1.7 Days/month Standard Error 0.3	-1.2 Days/month Standard Error 0.3	—	—	—

SECONDARY outcome

Timeframe: Baseline and average over Treatment Period (Weeks 0-12)

Population: The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.

Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 50% reduction in the monthly migraine days during the 12-week Treatment Period versus during Screening (Baseline) was analyzed using a generalized linear mixed effects model.

Outcome measures

Outcome measures
Measure	Treatment Period: MK-6096 n=115 Participants Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period	Treatment Period: Placebo n=112 Participants Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period	Run-out Period: MK-6096 / MK-6096 Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: MK-6096 / Placebo Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.	Run-out Period: Placebo / Placebo Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days	24.7 Percentage of participants 95% Confidence Interval 0.3 • Interval 18.8 to 31.6	21.1 Percentage of participants 95% Confidence Interval 0.3 • Interval 15.7 to 27.8	—	—	—

SECONDARY outcome

Timeframe: Baseline and average over Treatment Period (Weeks 0-12)

Population: The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.

Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 30% reduction in the monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was analyzed using a generalized linear mixed effects model.