Trial Outcomes & Findings for A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis (NCT NCT00812006)

NCT ID: NCT00812006

Last Updated: 2024-05-23

Results Overview

Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

108 participants

Primary outcome timeframe

2 hours post dose

Results posted on

2024-05-23

Participant Flow

First Patient In: 26 March 2009; Last Patient Last Visit: 22 October 2009. 17 Outpatient centers worldwide (10 United States; 2 Canada; 2 Spain, 2 Italy; 1 France)

Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible, were randomized at the same visit.

Participant milestones

Participant milestones
Measure	Rizatriptan / Rizatriptan / Placebo First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo	Rizatriptan / Placebo / Rizatriptan First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)	Placebo / Rizatriptan / Rizatriptan First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
Overall Study STARTED	36	36	36
Overall Study COMPLETED	30	33	30
Overall Study NOT COMPLETED	6	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Rizatriptan / Rizatriptan / Placebo First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo	Rizatriptan / Placebo / Rizatriptan First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)	Placebo / Rizatriptan / Rizatriptan First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
Overall Study Lost to Follow-up	0	0	2
Overall Study Physician Decision	0	0	1
Overall Study Withdrawal by Subject	2	1	1
Overall Study Lack of Qualifying Event	4	2	2

Baseline Characteristics

A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rizatriptan / Rizatriptan / Placebo n=36 Participants First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo	Rizatriptan / Placebo / Rizatriptan n=36 Participants First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)	Placebo / Rizatriptan / Rizatriptan n=36 Participants First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)	Total n=108 Participants Total of all reporting groups
Age, Continuous	48.3 years STANDARD_DEVIATION 12.0 • n=5 Participants	43.9 years STANDARD_DEVIATION 10.8 • n=7 Participants	40.0 years STANDARD_DEVIATION 11.6 • n=5 Participants	44.0 years STANDARD_DEVIATION 11.9 • n=4 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	33 Participants n=7 Participants	34 Participants n=5 Participants	99 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity Origin Black	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Ethnicity Origin White	36 participants n=5 Participants	35 participants n=7 Participants	36 participants n=5 Participants	107 participants n=4 Participants
Racial Origin Hispanic or Latino	11 participants n=5 Participants	9 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants
Racial Origin Not Hispanic or Latino	25 participants n=5 Participants	27 participants n=7 Participants	26 participants n=5 Participants	78 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 hours post dose

Population: Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.

Outcome measures

Outcome measures
Measure	Rizatriptan n=99 Participants Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.	Placebo n=93 Participants Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
Pain Relief (PR) Resulting in PR at 2 hours post dose	105 Attacks	21 Attacks
Pain Relief (PR) Not resulting in PR at 2 hours post dose	88 Attacks	72 Attacks

SECONDARY outcome

Timeframe: 2 - 24 hours post dose

Population: Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the attack must have met the FAS criteria for PR at 2 hours post-dose, and from 2-24 hours the participant either answered 24-hour headache recurrence question or didn't have PR at any time or took rescue.

24-hour sustained pain relief (defined as pain relief at 2 hours post dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the respective period after dosing with the blinded study medication.

Outcome measures

Outcome measures
Measure	Rizatriptan n=99 Participants Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.	Placebo n=93 Participants Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
Sustained Pain Relief (SPR) Resulting in SPR 2-24 hours post dose	67 Attacks	12 Attacks
Sustained Pain Relief (SPR) Not resulting in SPR 2-24 hours post dose	126 Attacks	81 Attacks

SECONDARY outcome

Timeframe: 2 hours post dose

Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.

Outcome measures

Outcome measures
Measure	Rizatriptan n=99 Participants Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.	Placebo n=93 Participants Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
Pain Freedom (PF) Resulting in PF 2 hours post dose	74 Attacks	9 Attacks
Pain Freedom (PF) Not resulting in PF 2 hours post dose	119 Attacks	84 Attacks

SECONDARY outcome

Timeframe: 2 hours post dose

Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired, or unable to do activities, requires bedrest. Functional disability ratings was dichotomized to Normal and Not Normal (mildly impaired, severely impaired, or unable to do activities, requires bedrest) for analysis.

Outcome measures

Outcome measures
Measure	Rizatriptan n=99 Participants Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.	Placebo n=93 Participants Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
Normal Rating of Functional Disability (NRFD) Resulting in NRFD at 2 hours post dose	85 Attacks	16 Attacks
Normal Rating of Functional Disability (NRFD) Not resulting in NRFD at 2 hours post dose	108 Attacks	77 Attacks

SECONDARY outcome

Timeframe: 24 hours post dose

Population: Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and post-dose satisfaction measurement at the 24-hour time point.

Patient satisfaction was assessed on a paper diary by the participants. Level of satisfaction was rated as: completely satisfied, very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied. The overall 24-hour assessment of study medication was dichotomized to Satisfaction (completely satisfied, very satisfied, somewhat satisfied) and Non-satisfaction (neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied) for analysis.

Outcome measures

Outcome measures
Measure	Rizatriptan n=99 Participants Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.	Placebo n=93 Participants Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
Treatment Satisfaction (TS) Resulting in TS at 24 hours post dose	117 Attacks	31 Attacks
Treatment Satisfaction (TS) Not resulting in TS at 24 hours post dose	76 Attacks	62 Attacks

Adverse Events

Rizatriptan

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Rizatriptan n=101 participants at risk Rizatriptan 10 mg. Patients who treated at least one attack with rizatriptan 10 mg (including sponsor-provided rescue) were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group. Adverse events occurring within 14 days of any administration of rizatriptan (including sponsor-provided rescue) were attributed to rizatriptan group, even if placebo was administered more recently. It is possible for one patient to be counted twice (once in each treatment group). The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo.	Placebo n=94 participants at risk Placebo. Patients who treated an attack with placebo were included. Adverse events occurring within 14 days of administration of placebo, but not within 14 days of any administration of rizatriptan (including sponsor-provided rescue), were attributed to placebo group. It is possible for one patient to be counted twice (once in each treatment group). The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo.
Gastrointestinal disorders Abdominal Distension	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Gastrointestinal disorders Abdominal pain upper	2.0% 2/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Gastrointestinal disorders Diarrhoea	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Gastrointestinal disorders Nausea	2.0% 2/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	1.1% 1/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
General disorders Chest discomfort	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
General disorders Fatigue	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	1.1% 1/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
General disorders Malaise	0.00% 0/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	1.1% 1/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
General disorders Temperature intolerance	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Immune system disorders Seasonal Allergy	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Infections and infestations Vaginal infection	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Injury, poisoning and procedural complications Intentional overdose	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Musculoskeletal and connective tissue disorders Arthalgia	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Musculoskeletal and connective tissue disorders Back pain	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Musculoskeletal and connective tissue disorders Pain in jaw	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Nervous system disorders Allodynia	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Nervous system disorders Dizziness	2.0% 2/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	1.1% 1/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Nervous system disorders Hypersomnia	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Nervous system disorders Hypoaesthesia	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Nervous system disorders Peripheral paralysis	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Nervous system disorders Somnolence	5.9% 6/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Psychiatric disorders Disorientation	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently
Renal and urinary disorders Pollakiuria	0.99% 1/101 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently	0.00% 0/94 • Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication. Adverse experiences were reported by the patient on a paper diary. Adverse events occurring within 14 days of administration of rizatriptan (including sponsor-provided rescue) are attributed to rizatriptan group, even if placebo was administered more recently