Trial Outcomes & Findings for Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081) (NCT NCT00516737)

NCT ID: NCT00516737

Last Updated: 2024-04-22

Results Overview

Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 207 participants
• Primary outcome timeframe: 2 hours post-dose
• Results posted on: 2024-04-22

Participant Flow

Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany)

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

Participant milestones

Measure	Rizatriptan 10 mg ODT Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo Matching placebo; one dose, treatment of a single migraine attack
Overall Study STARTED	103	104
Overall Study COMPLETED	92	96
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Measure	Rizatriptan 10 mg ODT Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo Matching placebo; one dose, treatment of a single migraine attack
Overall Study Lost to Follow-up	2	0
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	0	1
Overall Study Lack of Qualifying Event	9	6

Baseline Characteristics

Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

Baseline characteristics by cohort

Measure	Rizatriptan 10 mg ODT n=103 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo n=104 Participants Matching placebo; one dose, treatment of a single migraine attack	Total n=207 Participants Total of all reporting groups
Age, Continuous	41 years n=93 Participants	44 years n=4 Participants	42.5 years n=27 Participants
Sex: Female, Male Female	90 Participants n=93 Participants	96 Participants n=4 Participants	186 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	8 Participants n=4 Participants	21 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	4 participants n=93 Participants	3 participants n=4 Participants	7 participants n=27 Participants
Race/Ethnicity, Customized White	95 participants n=93 Participants	100 participants n=4 Participants	195 participants n=27 Participants
Race/Ethnicity, Customized Asian	2 participants n=93 Participants	1 participants n=4 Participants	3 participants n=27 Participants
Race/Ethnicity, Customized Multi-Racial	2 participants n=93 Participants	0 participants n=4 Participants	2 participants n=27 Participants

PRIMARY outcome

Timeframe: 2 hours post-dose

Population: Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.

Outcome measures

Measure	Rizatriptan 10 mg ODT n=92 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo n=96 Participants Matching placebo; one dose, treatment of a single migraine attack
Number of Participants Who Are Pain Free at 2 Hours Post-Dose	61 Participants	27 Participants

SECONDARY outcome

Timeframe: 24 hours post-dose

Population: The FAS population was used for this secondary variable of 24-hour sustained pain freedom, unless participants were otherwise identified as non-responders for this endpoint (i.e., took rescue up to 24 hours post-dose or were not pain free at 2 hours post-dose). To be included, participants must have also had a non-missing 24-hour assessment.

24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.

Outcome measures

Measure	Rizatriptan 10 mg ODT n=92 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo n=96 Participants Matching placebo; one dose, treatment of a single migraine attack
Number of Participants With 24-Hour Sustained Pain Freedom	48 Participants	17 Participants

SECONDARY outcome

Timeframe: 24 hours post-dose

Population: The FAS population included all randomized and treated participants.

Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.

Outcome measures

Measure	Rizatriptan 10 mg ODT n=92 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo n=96 Participants Matching placebo; one dose, treatment of a single migraine attack
Number of Participants With no Rescue Use up to 24 Hours Post-Dose	61 Participants	32 Participants

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.

Outcome measures

Measure	Rizatriptan 10 mg ODT n=92 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo n=96 Participants Matching placebo; one dose, treatment of a single migraine attack
Number of Participants With Absence of Photophobia at 2 Hours Post-dose	69 Participants	43 Participants

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.

Outcome measures

Measure	Rizatriptan 10 mg ODT n=92 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo n=96 Participants Matching placebo; one dose, treatment of a single migraine attack
Number of Participants With Absence of Phonophobia at 2 Hours Post-dose	72 Participants	55 Participants

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.

Outcome measures

Measure	Rizatriptan 10 mg ODT n=92 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo n=96 Participants Matching placebo; one dose, treatment of a single migraine attack
Number of Participants With Absence of Nausea at 2 Hours Post-dose	82 Participants	73 Participants

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

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 bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.

Outcome measures

Measure	Rizatriptan 10 mg ODT n=92 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo n=96 Participants Matching placebo; one dose, treatment of a single migraine attack
Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose	66 Participants	42 Participants

Adverse Events

Rizatriptan 10 mg ODT

Serious events: 0 serious events

Other events: 6 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

Measure	Rizatriptan 10 mg ODT n=92 participants at risk Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Placebo n=96 participants at risk Matching placebo; one dose, treatment of a single migraine attack
Gastrointestinal disorders Hyperchlorhydria	2.2% 2/92	0.00% 0/96
Gastrointestinal disorders Nausea	1.1% 1/92	0.00% 0/96
General disorders Fatigue	0.00% 0/92	1.0% 1/96
General disorders Feeling cold	0.00% 0/92	1.0% 1/96
General disorders Feeling jittery	1.1% 1/92	0.00% 0/96
General disorders Pain	1.1% 1/92	0.00% 0/96
Musculoskeletal and connective tissue disorders Myalgia	1.1% 1/92	0.00% 0/96
Nervous system disorders Balance disorder	1.1% 1/92	0.00% 0/96
Nervous system disorders Dizziness	2.2% 2/92	1.0% 1/96
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/92	1.0% 1/96
Respiratory, thoracic and mediastinal disorders Throat tightness	1.1% 1/92	0.00% 0/96

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

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