Trial Outcomes & Findings for Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea (NCT NCT00250458)

Last Updated: 2022-02-03

Results Overview

Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

346 participants

Primary outcome timeframe

At 2 hours after treatment

Results posted on

2022-02-03

Participant Flow

Twenty-Four (24) investigators in the United States Primary Therapy Period: MAR06 to OCT06.

Each patient was to treat one migraine attack of moderate or severe intensity with accompanying nausea. Rescue medication was allowed for headache non-response or recurrence after 2 hours postdose. Patients were to treat a qualifying migraine attack within 3 months after randomization.

Participant milestones

Participant milestones
Measure	Rizatriptan 10 mg Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack	Placebo Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
Overall Study STARTED	232	114
Overall Study COMPLETED	200	97
Overall Study NOT COMPLETED	32	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Rizatriptan 10 mg Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack	Placebo Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
Overall Study Lost to Follow-up	4	2
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	4	2
Overall Study Lack of Migraine Attack	20	9
Overall Study Qualifying migraine but did not treat	3	3
Overall Study Other	1	0

Baseline Characteristics

Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rizatriptan 10 mg n=232 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack	Placebo n=114 Participants Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack	Total n=346 Participants Total of all reporting groups
Age, Continuous	40 Years n=99 Participants	41 Years n=107 Participants	40 Years n=206 Participants
Sex: Female, Male Female	207 Participants n=99 Participants	103 Participants n=107 Participants	310 Participants n=206 Participants
Sex: Female, Male Male	25 Participants n=99 Participants	11 Participants n=107 Participants	36 Participants n=206 Participants

PRIMARY outcome

Timeframe: At 2 hours after treatment

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

Outcome measures

Outcome measures
Measure	Rizatriptan 10 mg n=185 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack	Placebo n=92 Participants Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
Participants With Elimination of Nausea at 2 Hours Postdose No Nausea at 2 Hours	130 Participants	57 Participants
Participants With Elimination of Nausea at 2 Hours Postdose Nausea at 2 Hours	55 Participants	35 Participants

SECONDARY outcome

Timeframe: 2 hours after treatment

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

Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment.

Outcome measures

Outcome measures
Measure	Rizatriptan 10 mg n=185 Participants Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack	Placebo n=92 Participants Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
Participants With Pain Relief at 2 Hours Postdose 2-Hour Pain Relief	129 Participants	50 Participants
Participants With Pain Relief at 2 Hours Postdose No 2-Hour Pain Relief	56 Participants	42 Participants

Adverse Events

Rizatriptan 10 mg

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 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

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

Other adverse events
Measure	Rizatriptan 10 mg n=200 participants at risk Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack	Placebo n=97 participants at risk Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
Cardiac disorders Palpitations	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Eye disorders Vision blurred	1.0% 2/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	1.0% 2/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Dry mouth	1.0% 2/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Dyspepsia	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Flatulence	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Gastroesophageal reflux disease	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Lip swelling	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Nausea	1.0% 2/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Paraesthesia oral	1.0% 2/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Salivary hypersecretion	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Stomatitis	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Gastrointestinal disorders Vomiting	1.0% 2/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
General disorders Fatigue	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	1.0% 1/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
General disorders Peripheral coldness	1.0% 2/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Infections and infestations Gastroenteritis	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Nervous system disorders Dizziness	2.0% 4/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	1.0% 1/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Nervous system disorders Dysgeusia	1.0% 2/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Nervous system disorders Headache	0.00% 0/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	1.0% 1/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Nervous system disorders Migraine	0.00% 0/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	1.0% 1/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Nervous system disorders Somnolence	2.0% 4/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Nervous system disorders Tremor	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Psychiatric disorders Dissociative disorder	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Psychiatric disorders Euphoric mood	0.00% 0/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	1.0% 1/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Psychiatric disorders Insomnia	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Psychiatric disorders Pharyngeal hypoaesthesia	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Skin and subcutaneous tissue disorders Cold sweat	0.50% 1/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	0.00% 0/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
Skin and subcutaneous tissue disorders Hypoaesthesia facial	0.00% 0/200 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.	1.0% 1/97 • Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy. Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.