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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rizatriptan 5 mg | Experimental | 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) |
|
| Rizatriptan 10 mg | Experimental | 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) |
|
| Standard Care | Active Comparator | Standard care at onset of migraine attack |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rizatriptan 5 mg | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours after initial dose of test drug |
| 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. | Up to 12 months |
| 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. | Up to 12 months |
| Number of Participants Who Discontinued Due to Clinical Adverse Experiences | Up to 12 months | |
| 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. | Up to 12 weeks |
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Inclusion Criteria:
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | Standard Care | Standard care at onset of migraine attack |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Rizatriptan 10 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All patients who took study medication and filled out their diary cards were included in the analysis of efficacy. No data were imputed. | Posted | Median | Inter-Quartile Range | percent of headaches | 2 hours after initial dose of test drug |
|
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The 'total # participants affected' w/ Other AEs DOES include subjects w/ any AE (including SAEs) >1 event. The true overall # of subjects affected w/ only any NonSerious AE >5% is less than the # reported, but unable to be determined for this pooled extension period.
Specific Other AEs reported DO NOT include SAEs and DO NOT include events <5%
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hernia, inguinal | General disorders | Body as a whole/site unspecific (SOC) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia/fatigue | General disorders | Body as a Whole/Site Unspecific (SOC) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C093622 | rizatriptan |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Rizatriptan 10 mg | Drug | 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) |
|
|
| Standard Care | Drug | Active standard care |
|
| Withdrawal by Subject |
|
| Lack of Response |
|
| Other |
|
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)
| BG002 | Standard Care | Standard care at onset of migraine attack |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| 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) |
| OG002 | Standard Care | Standard care at onset of migraine attack |
|
|
| 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. | All patients who took study medication were included in the analysis. | Posted | Number | participants | Up to 12 months |
|
|
|
| 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. | All patients who took study medication were included in the analysis. | Posted | Number | participants | Up to 12 months |
|
|
|
| Primary | Number of Participants Who Discontinued Due to Clinical Adverse Experiences | All patients who took study medication were included in the analysis. | Posted | Number | participants | Up to 12 months |
|
|
|
| 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. | All patients who took study medication and had lab test(s)were included in the analysis. | Posted | Number | participants | Up to 12 weeks |
|
|
|
| 13 |
| 711 |
| 492 |
| 711 |
| EG001 | 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) | 17 | 834 | 679 | 834 |
| EG002 | Standard Care | Standard care at onset of migraine attack | 10 | 334 | 267 | 334 |
| Melanoma | General disorders | Body as a whole/site unspecific (SOC) |
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| Pain, abdominal | General disorders | Body as a whole/site unspecific (SOC) |
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| Pain, chest | General disorders | Body as a whole/site unspecific (SOC) |
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| Septicimea | General disorders | Body as a whole/site unspecific (SOC) |
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| Surgery, abdominal | General disorders | Body as a whole/site unspecific (SOC) |
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| Trauma | General disorders | Body as a whole/site unspecific (SOC) |
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| Embolism/infarction, pulmonary | Cardiac disorders |
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| Appendicitis | Gastrointestinal disorders |
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| Cholelithiasis | Gastrointestinal disorders |
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| Gastroenteritis | Gastrointestinal disorders |
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| Hemorrhage, anal/rectal | Gastrointestinal disorders |
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| Rectocele | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Neoplasm, thyroid, malignant | Endocrine disorders |
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| Agranulocytosis | Blood and lymphatic system disorders |
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| Thrombocytopenia | Blood and lymphatic system disorders |
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| Anaphylaxis | Metabolism and nutrition disorders | Metabolic/Nutritional/Immune (SOC) |
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| Dehydration | Metabolism and nutrition disorders | Metabolic/Nutritional/Immune (SOC) |
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| Fracture, elbow, right | Musculoskeletal and connective tissue disorders |
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| Fracture, hip, right | Musculoskeletal and connective tissue disorders |
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| Pain, back | Musculoskeletal and connective tissue disorders |
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| Pain, knee | Musculoskeletal and connective tissue disorders |
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| Pain, neck | Musculoskeletal and connective tissue disorders |
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| Trauma, cartilage | Musculoskeletal and connective tissue disorders |
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| Anxiety | Nervous system disorders | Nervous System and Psychiatric (SOC) |
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| Depression | Nervous system disorders | Nervous System and Psychiatric (SOC) |
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| Headache | Nervous system disorders | Nervous System and Psychiatric (SOC) |
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| Meningitis | Nervous system disorders | Nervous System and Psychiatric (SOC) |
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| Migraine | Nervous system disorders | Nervous System and Psychiatric (SOC) |
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| Asthma | Respiratory, thoracic and mediastinal disorders |
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| Wheezing | Respiratory, thoracic and mediastinal disorders |
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| Neoplasm, skin, malignant | Skin and subcutaneous tissue disorders |
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| Abortion | Reproductive system and breast disorders | Urogenital System (SOC) |
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| Cystocele | Reproductive system and breast disorders | Urogenital System (SOC) |
|
| Hypertrophy, uterine | Reproductive system and breast disorders | Urogenital System (SOC) |
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| Neoplasm, breast, malignant | Reproductive system and breast disorders | Urogenital System (SOC) |
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| Neoplasm, uterine, benign | Reproductive system and breast disorders | Urogenital System (SOC) |
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| Pregnancy | Reproductive system and breast disorders | Urogenital System (SOC) |
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| Prostatitis | Reproductive system and breast disorders | Urogenital System (SOC) |
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| Pain, abdominal | General disorders | Body as a Whole/Site Unspecific (SOC) |
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| Pain, chest | General disorders | Body as a Whole/Site Unspecific (SOC) |
|
| Diarrhea | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Pain, back | Musculoskeletal and connective tissue disorders |
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| Dizziness | Nervous system disorders | Nervous System and Psychiatric (SOC) |
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| Headache | Nervous system disorders | Nervous System and Psychiatric (SOC) |
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| Insomnia | Nervous system disorders | Nervous System and Psychiatric (SOC) |
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| Paresthesia | Nervous system disorders | Nervous System and Psychiatric (SOC) |
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| Somnolence | Nervous system disorders | Nervous System and Psychiatric (SOC) |
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| Infection, respiratory, upper | Respiratory, thoracic and mediastinal disorders |
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| Influenza | Respiratory, thoracic and mediastinal disorders |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders |
|
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.
| D009422 | Nervous System Diseases |
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