Trial Outcomes & Findings for Zomig - Treatment of Acute Migraine Headache in Adolescents (NCT NCT01211145)

NCT ID: NCT01211145

Last Updated: 2016-05-18

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1653 participants

Primary outcome timeframe

2 hours post-treatment.

Results posted on

2016-05-18

Participant Flow

This multicenter study was conducted between 7 October 2010 and 31 October 2013.

The study had a 30 day run-in period and up to a 10-week double-blind treatment period. Patients were randomized to receive ZOMIG nasal spray 0.5, 2.5, 5.0 mg, or matching placebo spray to treat a migraine headache. 1653 patients were enrolled, 798 were randomized.

Participant milestones

Participant milestones
Measure	Placebo Placebo to ZOMIG nasal spray	ZOMIG 0.5 mg ZOMIG nasal spray	ZOMIG 2.5 mg ZOMIG nasal spray	ZOMIG 5 mg ZOMIG nasal spray
Overall Study STARTED	296	115	99	288
Overall Study COMPLETED	270	98	86	268
Overall Study NOT COMPLETED	26	17	13	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo to ZOMIG nasal spray	ZOMIG 0.5 mg ZOMIG nasal spray	ZOMIG 2.5 mg ZOMIG nasal spray	ZOMIG 5 mg ZOMIG nasal spray
Overall Study Reason not specified	3	2	2	1
Overall Study Lost to Follow-up	3	2	1	2
Overall Study Study-specific withdrawal criteria	1	0	0	0
Overall Study Severe noncompliance to protocol	1	0	0	0
Overall Study Eligibility criteria not fulfilled	16	12	10	15
Overall Study Patient decision	2	1	0	2

Baseline Characteristics

Zomig - Treatment of Acute Migraine Headache in Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=296 Participants Placebo to ZOMIG nasal spray	ZOMIG 0.5 mg n=115 Participants ZOMIG nasal spray	ZOMIG 2.5 mg n=99 Participants ZOMIG nasal spray	ZOMIG 5 mg n=288 Participants ZOMIG nasal spray	Total n=798 Participants Total of all reporting groups
Age, Continuous	14.3 Years STANDARD_DEVIATION 1.67 • n=5 Participants	14.5 Years STANDARD_DEVIATION 1.72 • n=7 Participants	14.6 Years STANDARD_DEVIATION 1.77 • n=5 Participants	14.5 Years STANDARD_DEVIATION 1.67 • n=4 Participants	14.4 Years STANDARD_DEVIATION 1.69 • n=21 Participants
Sex: Female, Male Female	188 Participants n=5 Participants	71 Participants n=7 Participants	62 Participants n=5 Participants	172 Participants n=4 Participants	493 Participants n=21 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	44 Participants n=7 Participants	37 Participants n=5 Participants	116 Participants n=4 Participants	305 Participants n=21 Participants

PRIMARY outcome

Timeframe: 2 hours post-treatment.

Population: Full analysis set (last observation carried forward)

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Placebo to ZOMIG nasal spray	ZOMIG 0.5 mg n=91 Participants ZOMIG nasal spray	ZOMIG 2.5 mg n=81 Participants ZOMIG nasal spray	ZOMIG 5 mg n=229 Participants ZOMIG nasal spray
Pain-free Status at 2 Hours Post-treatment No	211 Participants	71 Participants	61 Participants	161 Participants
Pain-free Status at 2 Hours Post-treatment Yes	42 Participants	20 Participants	20 Participants	68 Participants

SECONDARY outcome

Timeframe: 24 hours post-treatment

Population: Full analysis set (observed case)

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo to ZOMIG nasal spray	ZOMIG 0.5 mg n=91 Participants ZOMIG nasal spray	ZOMIG 2.5 mg n=80 Participants ZOMIG nasal spray	ZOMIG 5 mg n=227 Participants ZOMIG nasal spray
Pain-free Status at 24 Hours Post-treatment Yes	155 Participants	59 Participants	60 Participants	155 Participants
Pain-free Status at 24 Hours Post-treatment No	96 Participants	32 Participants	20 Participants	72 Participants

SECONDARY outcome

Timeframe: 2 hours post-treatment

Population: Full analysis set (last observation carried forward)

Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Placebo to ZOMIG nasal spray	ZOMIG 0.5 mg n=91 Participants ZOMIG nasal spray	ZOMIG 2.5 mg n=81 Participants ZOMIG nasal spray	ZOMIG 5 mg n=229 Participants ZOMIG nasal spray
Headache Response at 2 Hours Post-treatment Yes	99 Participants	40 Participants	43 Participants	116 Participants
Headache Response at 2 Hours Post-treatment No	154 Participants	51 Participants	38 Participants	113 Participants

SECONDARY outcome

Timeframe: 24 hours post-treatment

Population: Full analysis set (observed case)

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo to ZOMIG nasal spray	ZOMIG 0.5 mg n=91 Participants ZOMIG nasal spray	ZOMIG 2.5 mg n=80 Participants ZOMIG nasal spray	ZOMIG 5 mg n=227 Participants ZOMIG nasal spray
Headache Response at 24 Hours Post-treatment Yes	170 Participants	63 Participants	61 Participants	168 Participants
Headache Response at 24 Hours Post-treatment No	81 Participants	28 Participants	19 Participants	59 Participants

SECONDARY outcome

Timeframe: Up to 2 hours post-treatment

Population: Full analysis set (observed case)

Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo to ZOMIG nasal spray	ZOMIG 0.5 mg n=91 Participants ZOMIG nasal spray	ZOMIG 2.5 mg n=81 Participants ZOMIG nasal spray	ZOMIG 5 mg n=224 Participants ZOMIG nasal spray
Sustained Headache Response at 2 Hours Yes	59 Participants	27 Participants	27 Participants	66 Participants
Sustained Headache Response at 2 Hours No	192 Participants	64 Participants	54 Participants	158 Participants

SECONDARY outcome

Timeframe: 24 hours post-treatment.

Population: Full analysis set (observed cases)

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Placebo to ZOMIG nasal spray	ZOMIG 0.5 mg n=91 Participants ZOMIG nasal spray	ZOMIG 2.5 mg n=81 Participants ZOMIG nasal spray	ZOMIG 5 mg n=231 Participants ZOMIG nasal spray
Use of Rescue Medication During the First 24 Hours After Treatment Yes	80 Participants	22 Participants	18 Participants	47 Participants
Use of Rescue Medication During the First 24 Hours After Treatment No	173 Participants	69 Participants	63 Participants	184 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

ZOMIG 0.5 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

ZOMIG 2.5 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

ZOMIG 5 mg

Serious events: 0 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Jamie Mullen, Medical Science Director

AstraZeneca

Phone: 781-472-5032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Placebo n=253 participants at risk Placebo to ZOMIG nasal spray	ZOMIG 0.5 mg n=92 participants at risk ZOMIG nasal spray	ZOMIG 2.5 mg n=81 participants at risk ZOMIG nasal spray	ZOMIG 5 mg n=231 participants at risk ZOMIG nasal spray
Nervous system disorders Dysgeusia	1.2% 3/253 • Number of events 3 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	6.5% 6/92 • Number of events 6 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	6.2% 5/81 • Number of events 5 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	12.6% 29/231 • Number of events 29 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Nervous system disorders Dizziness	0.79% 2/253 • Number of events 2 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.1% 1/92 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	2.6% 6/231 • Number of events 6 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Nasal discomfort	1.6% 4/253 • Number of events 4 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.1% 1/92 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	2.5% 2/81 • Number of events 2 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	3.0% 7/231 • Number of events 7 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.6% 4/253 • Number of events 4 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.1% 1/92 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	3.0% 7/231 • Number of events 7 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Gastrointestinal disorders Nausea	1.2% 3/253 • Number of events 3 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.2% 1/81 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	2.2% 5/231 • Number of events 5 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Gastrointestinal disorders Abdominal pain upper	1.2% 3/253 • Number of events 3 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.2% 1/81 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Nervous system disorders Paraesthesia	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.1% 1/92 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.2% 1/81 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.87% 2/231 • Number of events 2 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Nervous system disorders Hypoaesthesia	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.1% 1/92 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Nervous system disorders Somnolence	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.3% 3/231 • Number of events 3 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Nervous system disorders Bradykinesia	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Nervous system disorders Burning sensation	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Nervous system disorders Head discomfort	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Gastrointestinal disorders Vomiting	1.2% 3/253 • Number of events 3 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/231 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Gastrointestinal disorders Oral discomfort	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Gastrointestinal disorders Oral pain	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Gastrointestinal disorders Oral pruritus	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/231 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Throat irritation	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.3% 3/231 • Number of events 3 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.87% 2/231 • Number of events 2 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.79% 2/253 • Number of events 2 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Sneezing	0.79% 2/253 • Number of events 2 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/231 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/231 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/231 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
General disorders Fatigue	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.3% 3/231 • Number of events 3 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
General disorders Asthenia	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
General disorders Chills	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.1% 1/92 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
General disorders Facial pain	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
General disorders Feeling cold	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/231 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
General disorders Feeling hot	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	1.1% 1/92 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/231 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.87% 2/231 • Number of events 2 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Musculoskeletal and connective tissue disorders Muscular weakness	0.40% 1/253 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/231 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/253 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/92 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.00% 0/81 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)	0.43% 1/231 • Number of events 1 Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)