Migraine
Conditions
Brief summary
Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.
Interventions
DRUGComparator: Rizatriptan
One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
DRUGComparator: Placebo
One dose matching placebo to Rizatriptan to treat one migraine attack.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month
Exclusion criteria
* Heart disease, high blood pressure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Elimination of Nausea at 2 Hours Postdose | At 2 hours after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Pain Relief at 2 Hours Postdose | 2 hours after treatment | 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. |
Participant flow
Recruitment details
Twenty-Four (24) investigators in the United States Primary Therapy Period: MAR06 to OCT06.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Rizatriptan 10 mg Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack | 232 |
| Placebo Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack | 114 |
| Total | 346 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Migraine Attack | 20 | 9 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Qualifying migraine but did not treat | 3 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Rizatriptan 10 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 40 Years | 41 Years | 40 Years |
| Sex: Female, Male Female | 207 Participants | 103 Participants | 310 Participants |
| Sex: Female, Male Male | 25 Participants | 11 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 200 | 4 / 97 |
| serious Total, serious adverse events | 0 / 200 | 0 / 97 |
Outcome results
Primary
Participants With Elimination of Nausea at 2 Hours Postdose
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rizatriptan 10 mg | Participants With Elimination of Nausea at 2 Hours Postdose | No Nausea at 2 Hours | 130 Participants |
| Rizatriptan 10 mg | Participants With Elimination of Nausea at 2 Hours Postdose | Nausea at 2 Hours | 55 Participants |
| Placebo | Participants With Elimination of Nausea at 2 Hours Postdose | No Nausea at 2 Hours | 57 Participants |
| Placebo | Participants With Elimination of Nausea at 2 Hours Postdose | Nausea at 2 Hours | 35 Participants |
Secondary
Participants With Pain Relief at 2 Hours Postdose
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rizatriptan 10 mg | Participants With Pain Relief at 2 Hours Postdose | 2-Hour Pain Relief | 129 Participants |
| Rizatriptan 10 mg | Participants With Pain Relief at 2 Hours Postdose | No 2-Hour Pain Relief | 56 Participants |
| Placebo | Participants With Pain Relief at 2 Hours Postdose | 2-Hour Pain Relief | 50 Participants |
| Placebo | Participants With Pain Relief at 2 Hours Postdose | No 2-Hour Pain Relief | 42 Participants |