Migraine Disorders
Conditions
Keywords
Migraine headache
Brief summary
This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949); MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence.
Interventions
DRUGRizatriptan 5 mg
Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
DRUGRizatriptan 10 mg
Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
DRUGStandard Care
Active standard care
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029 * History of migraine headache
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug | 2 hours after initial dose of test drug | Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1. |
| Number of Participants With Serious Clinical Adverse Experiences | Up to 12 months | Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. |
| Number of Participants With Drug-related Clinical Adverse Experiences | Up to 12 months | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs. |
| Number of Participants Who Discontinued Due to Clinical Adverse Experiences | Up to 12 months | — |
| Number of Participants With Drug-related Lab Adverse Experiences | Up to 12 weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE). A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. |
Participant flow
Pre-assignment details
All participants that completed protocol MK-0462-022 (NCT00897949), MK-0462-025 (NCT00899379), or MK-0462-029 (NCT00897104) and consented to continue in the studies up to 12 months were included in this pooled extension data.
Participants by arm
| Arm | Count |
|---|---|
| Rizatriptan 5 mg Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) | 751 |
| Rizatriptan 10 mg Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) | 857 |
| Standard Care Standard care at onset of migraine attack | 351 |
| Total | 1,959 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 27 | 41 | 8 |
| Overall Study | Lack of Response | 92 | 38 | 8 |
| Overall Study | Lost to Follow-up | 49 | 43 | 20 |
| Overall Study | Other | 37 | 47 | 13 |
| Overall Study | Withdrawal by Subject | 93 | 79 | 41 |
Baseline characteristics
| Characteristic | Rizatriptan 5 mg | Rizatriptan 10 mg | Standard Care | Total |
|---|---|---|---|---|
| Age, Continuous | 41.6 years | 41.1 years | 40.7 years | 41.2 years |
| Sex: Female, Male Female | 643 Participants | 727 Participants | 300 Participants | 1670 Participants |
| Sex: Female, Male Male | 108 Participants | 130 Participants | 51 Participants | 289 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 492 / 711 | 679 / 834 | 267 / 334 |
| serious Total, serious adverse events | 13 / 711 | 17 / 834 | 10 / 334 |
Outcome results
Primary
Number of Participants Who Discontinued Due to Clinical Adverse Experiences
Time frame: Up to 12 months
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rizatriptan 5 mg | Number of Participants Who Discontinued Due to Clinical Adverse Experiences | Discontinued due to CAEs | 26 participants |
| Rizatriptan 5 mg | Number of Participants Who Discontinued Due to Clinical Adverse Experiences | Not discontinued due to CAEs | 685 participants |
| Rizatriptan 10 mg | Number of Participants Who Discontinued Due to Clinical Adverse Experiences | Discontinued due to CAEs | 37 participants |
| Rizatriptan 10 mg | Number of Participants Who Discontinued Due to Clinical Adverse Experiences | Not discontinued due to CAEs | 797 participants |
| Standard Care | Number of Participants Who Discontinued Due to Clinical Adverse Experiences | Discontinued due to CAEs | 7 participants |
| Standard Care | Number of Participants Who Discontinued Due to Clinical Adverse Experiences | Not discontinued due to CAEs | 327 participants |
Primary
Number of Participants With Drug-related Clinical Adverse Experiences
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Time frame: Up to 12 months
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rizatriptan 5 mg | Number of Participants With Drug-related Clinical Adverse Experiences | With drug-related CAEs | 288 participants |
| Rizatriptan 5 mg | Number of Participants With Drug-related Clinical Adverse Experiences | Without drug-related CAEs | 423 participants |
| Rizatriptan 10 mg | Number of Participants With Drug-related Clinical Adverse Experiences | With drug-related CAEs | 456 participants |
| Rizatriptan 10 mg | Number of Participants With Drug-related Clinical Adverse Experiences | Without drug-related CAEs | 378 participants |
| Standard Care | Number of Participants With Drug-related Clinical Adverse Experiences | With drug-related CAEs | 139 participants |
| Standard Care | Number of Participants With Drug-related Clinical Adverse Experiences | Without drug-related CAEs | 195 participants |
Primary
Number of Participants With Drug-related Lab Adverse Experiences
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE). A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Time frame: Up to 12 weeks
Population: All patients who took study medication and had lab test(s)were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan 5 mg | Number of Participants With Drug-related Lab Adverse Experiences | 15 participants |
| Rizatriptan 10 mg | Number of Participants With Drug-related Lab Adverse Experiences | 23 participants |
| Standard Care | Number of Participants With Drug-related Lab Adverse Experiences | 4 participants |
Primary
Number of Participants With Serious Clinical Adverse Experiences
Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: Up to 12 months
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rizatriptan 5 mg | Number of Participants With Serious Clinical Adverse Experiences | With Serious CAEs | 13 participants |
| Rizatriptan 5 mg | Number of Participants With Serious Clinical Adverse Experiences | Without Serious CAEs | 698 participants |
| Rizatriptan 10 mg | Number of Participants With Serious Clinical Adverse Experiences | With Serious CAEs | 17 participants |
| Rizatriptan 10 mg | Number of Participants With Serious Clinical Adverse Experiences | Without Serious CAEs | 817 participants |
| Standard Care | Number of Participants With Serious Clinical Adverse Experiences | With Serious CAEs | 10 participants |
| Standard Care | Number of Participants With Serious Clinical Adverse Experiences | Without Serious CAEs | 324 participants |
Primary
Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug
Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1.
Time frame: 2 hours after initial dose of test drug
Population: All patients who took study medication and filled out their diary cards were included in the analysis of efficacy. No data were imputed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rizatriptan 5 mg | Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug | 80 percent of headaches |
| Rizatriptan 10 mg | Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug | 89.5 percent of headaches |
| Standard Care | Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug | 69.6 percent of headaches |