Zomig - Treatment of Acute Migraine Headache in Adolescents | NCT01211145

Label	Type	Description	Intervention Names
1	Placebo Comparator	Placebo	Drug: Placebo
2	Experimental	ZOMIG 0.5 mg	Drug: Zolmitriptan
3	Experimental	ZOMIG 2.5 mg	Drug: Zolmitriptan
4	Experimental	ZOMIG 5.0 mg	Drug: Zolmitriptan

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo nasal spray	1
Zolmitriptan

Measure	Description	Time Frame
Pain-free Status at 2 Hours Post-treatment		2 hours post-treatment.

Measure	Description	Time Frame
Pain-free Status at 24 Hours Post-treatment		24 hours post-treatment
Headache Response at 2 Hours Post-treatment	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.

Name	Affiliation	Role
Rohini Chitra	AZ Pharmaceuticals, US	Study Director
Paul Winner	Children's Hospital of The King's Daughters	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Phoenix	Arizona		United States
Research Site

Label	URL
D1220C00001 Clinical Study Report Synopsis	View source
D1220C00001 Revised CSP 3 Redacted	View source

ID	Title	Description
FG000	Placebo	Placebo to ZOMIG nasal spray
FG001	ZOMIG 0.5 mg	ZOMIG nasal spray

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pain-free Status at 2 Hours Post-treatment

Full analysis set (last observation carried forward)

Posted

Number

Participants

2 hours post-treatment.

ID	Title	Description
OG000	Placebo	Placebo to ZOMIG nasal spray
OG001	ZOMIG 0.5 mg	ZOMIG nasal spray
OG002	ZOMIG 2.5 mg	ZOMIG nasal spray
OG003	ZOMIG 5 mg	ZOMIG nasal spray

Units	Counts
Participants	OG000253 OG00191 OG00281 OG003

Title

Denominators

Categories

Yes

Title	Measurements
	OG00042 OG00120 OG00220 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		.312	Unadjusted	Odds Ratio (OR)	1.37			2-Sided	95	0.75	2.50			ZOMIG 0.5 mg/Placebo	No	Superiority or Other
OG000 OG002		Regression, Logistic

Secondary

Pain-free Status at 24 Hours Post-treatment

Full analysis set (observed case)

Posted

Number

Participants

24 hours post-treatment

ID	Title	Description
OG000	Placebo	Placebo to ZOMIG nasal spray
OG001	ZOMIG 0.5 mg	ZOMIG nasal spray
OG002	ZOMIG 2.5 mg	ZOMIG nasal spray
OG003	ZOMIG 5 mg	ZOMIG nasal spray

Units	Counts
Participants	OG000

Secondary

Headache Response at 2 Hours Post-treatment

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.

Full analysis set (last observation carried forward)

Posted

Number

Participants

2 hours post-treatment

ID	Title	Description
OG000	Placebo	Placebo to ZOMIG nasal spray
OG001	ZOMIG 0.5 mg	ZOMIG nasal spray
OG002	ZOMIG 2.5 mg	ZOMIG nasal spray
OG003	ZOMIG 5 mg	ZOMIG nasal spray

Units	Counts

Secondary

Headache Response at 24 Hours Post-treatment

Full analysis set (observed case)

Posted

Number

Participants

24 hours post-treatment

ID	Title	Description
OG000	Placebo	Placebo to ZOMIG nasal spray
OG001	ZOMIG 0.5 mg	ZOMIG nasal spray
OG002	ZOMIG 2.5 mg	ZOMIG nasal spray
OG003	ZOMIG 5 mg	ZOMIG nasal spray

Units	Counts

Secondary

Sustained Headache Response at 2 Hours

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.

Full analysis set (observed case)

Posted

Number

Participants

Up to 2 hours post-treatment

ID	Title	Description
OG000	Placebo	Placebo to ZOMIG nasal spray
OG001	ZOMIG 0.5 mg	ZOMIG nasal spray
OG002	ZOMIG 2.5 mg	ZOMIG nasal spray
OG003	ZOMIG 5 mg	ZOMIG nasal spray

Secondary

Use of Rescue Medication During the First 24 Hours After Treatment

Full analysis set (observed cases)

Posted

Number

Participants

24 hours post-treatment.

ID	Title	Description
OG000	Placebo	Placebo to ZOMIG nasal spray
OG001	ZOMIG 0.5 mg	ZOMIG nasal spray
OG002	ZOMIG 2.5 mg	ZOMIG nasal spray
OG003	ZOMIG 5 mg	ZOMIG nasal spray

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dysgeusia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected253 at risk EG0016 events6 affected92 at risk EG0025 events5 affected81 at risk EG00329 events29 affected231 at risk
Dizziness	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected253 at risk EG0011 events1 affected92 at risk EG0020 events0 affected81 at risk EG003
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected253 at risk EG0011 events1 affected92 at risk EG0022 events2 affected81 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected253 at risk EG0011 events1 affected92 at risk EG0020 events0 affected81 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected253 at risk EG0010 events0 affected92 at risk EG0021 events1 affected81 at risk EG003
Abdominal pain upper	Gastrointestinal disorders		Systematic Assessment	EG0003 events3 affected253 at risk EG0010 events0 affected92 at risk EG0021 events1 affected81 at risk EG003
Paraesthesia	Nervous system disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0011 events1 affected92 at risk EG0021 events1 affected81 at risk EG003
Hypoaesthesia	Nervous system disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0011 events1 affected92 at risk EG0020 events0 affected81 at risk EG003
Somnolence	Nervous system disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Bradykinesia	Nervous system disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Burning sensation	Nervous system disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Head discomfort	Nervous system disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Vomiting	Gastrointestinal disorders		Systematic Assessment	EG0003 events3 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Oral discomfort	Gastrointestinal disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Oral pain	Gastrointestinal disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Oral pruritus	Gastrointestinal disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Rhinalgia	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 events2 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 events2 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Fatigue	General disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Asthenia	General disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Chills	General disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0011 events1 affected92 at risk EG0020 events0 affected81 at risk EG003
Facial pain	General disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Feeling cold	General disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Feeling hot	General disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0011 events1 affected92 at risk EG0020 events0 affected81 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Eye irritation	Eye disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Photopsia	Eye disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Vision blurred	Eye disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Vertigo	Ear and labyrinth disorders		Systematic Assessment	EG0001 events1 affected253 at risk EG0011 events1 affected92 at risk EG0020 events0 affected81 at risk EG003
Influenza	Infections and infestations		Systematic Assessment	EG0000 events0 affected253 at risk EG0011 events1 affected92 at risk EG0020 events0 affected81 at risk EG003
Administration related reaction	Injury, poisoning and procedural complications		Systematic Assessment	EG0000 events0 affected253 at risk EG0011 events1 affected92 at risk EG0020 events0 affected81 at risk EG003
Disorientation	Psychiatric disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003
Erythema	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0000 events0 affected253 at risk EG0010 events0 affected92 at risk EG0020 events0 affected81 at risk EG003

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Placebo	Placebo to ZOMIG nasal spray
BG001	ZOMIG 0.5 mg	ZOMIG nasal spray
BG002	ZOMIG 2.5 mg	ZOMIG nasal spray
BG003	ZOMIG 5 mg	ZOMIG nasal spray
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo to ZOMIG nasal spray	253	25	253
EG001	ZOMIG 0.5 mg	ZOMIG nasal spray	92	14	92
EG002	ZOMIG 2.5 mg	ZOMIG nasal spray	81	9	81
EG003	ZOMIG 5 mg	ZOMIG nasal spray	231	59	231