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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_589 |
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A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo.
The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rizatriptan 10 mg | Experimental |
| |
| Rizatriptan 5 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rizatriptan benzoate (MK0462) | Drug | Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief at 2 Hours After the Initial Dose of Test Drug | Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain. | 2 hours after initial dose of test drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Free at 2 Hours After the Initial Dose of Test Drug | Patients reporting pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain. | 2 hours after initial dose of test drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19222588 | Background | Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12. | |
| 19210513 | Background | Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3. |
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Outpatients randomized at the prestudy visit were given study drug and administration instructions. If patients had not treated an attack within 2 months of being enrolled, they were required to return for a rescreen visit. If by 4 months after being enrolled patients still had not treated an attack, they were discontinued from the study
Patients were recruited at 28 sites in the United States and 18 in 9 other countries.
First Patient Treated: Mar 1995
Last Patient Treated: Jan 1996.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rizatriptan 5 mg | Rizatriptan 5 mg orally once for treatment of single migraine attack |
| FG001 | Rizatriptan 10 mg | Rizatriptan 10 mg orally once for treatment of single migraine attack |
| FG002 | Placebo | Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment |
| 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 single migraine attack |
| BG001 | Rizatriptan 10 mg | Rizatriptan 10 mg orally once for treatment of single migraine attack |
| 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 | Pain Relief at 2 Hours After the Initial Dose of Test Drug | Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain. | The primary analysis employed an "all-patients-treated" approach that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value. | Posted | Number | Participants | 2 hours after initial dose of test drug |
|
During the 24 hours treatment period, and up to and including 7 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
The subjects reported at risk are subjects with follow-up after at least one dose of study drug.
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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 single migraine attack |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia/Fatigue | General disorders | CRISP Dictionary | Non-systematic Assessment |
Pooled Extension data for PN022- NCT00897949; PN025- NCT00899379 and PN029- NCT00897104 appears in NCT01286207
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President,Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | 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 |
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| Comparator: placebo | Drug | Placebo to rizatriptan |
|
| No Disability at 2 Hours After the Initial Dose of Test Drug | Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 - Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest | 2 hours after initial dose of test drug |
| Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug | 2 hours after initial dose of test drug |
| Pain Relief 2 Hours After Treatment for Headache Recurrence | Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours). | 2 hours after treatment for recurrence |
| 9595867 | Result | Teall J, Tuchman M, Cutler N, Gross M, Willoughby E, Smith B, Jiang K, Reines S, Block G. Rizatriptan (MAXALT) for the acute treatment of migraine and migraine recurrence. A placebo-controlled, outpatient study. Rizatriptan 022 Study Group. Headache. 1998 Apr;38(4):281-7. doi: 10.1046/j.1526-4610.1998.3804281.x. |
| 11284464 | Result | Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71. doi: 10.1046/j.1526-4610.1998.3810764.x. |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient Uncoorperative |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Abnormal Prestudy Labs |
|
| Abnormal Baseline ECG |
|
| Need for Concom. Med. |
|
| Lack of Migraine Attack |
|
| Did not take study drug |
|
| BG002 | Placebo | Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Baseline Headache Severity | Each patient rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) | Number | Participants |
|
| OG001 |
| Rizatriptan 10 mg |
Rizatriptan 10 mg orally once for treatment of single migraine attack |
| OG002 | Placebo | Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment |
|
|
| Secondary | Pain Free at 2 Hours After the Initial Dose of Test Drug | Patients reporting pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain. | An "all-patients-treated" approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value. | Posted | Number | Participants | 2 hours after initial dose of test drug |
|
|
|
| Secondary | No Disability at 2 Hours After the Initial Dose of Test Drug | Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 - Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest | An "all-patients-treated" approach was employed that included all patients who had at least one record of functional disability within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value. | Posted | Number | Participants | 2 hours after initial dose of test drug |
|
|
|
| Secondary | Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug | An "all-patients-treated" approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value. | Posted | Number | Participants | 2 hours after initial dose of test drug |
|
|
|
| Secondary | Pain Relief 2 Hours After Treatment for Headache Recurrence | Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours). | Patients with initial headache recurrence who took rizatriptan 5 mg or 10 mg were prerandomized (ratio=1:1) to either rizatriptan 5 mg or 10 mg, respectively, or to placebo (ratio=1:1); and who took placebo, to either 5 mg or 10 mg of rizatriptan (ratio=1:1). Only those who took rizatriptan for their initial headache were considered for analysis. | Posted | Number | Participants | 2 hours after treatment for recurrence |
|
|
|
| 3 |
| 456 |
| 155 |
| 456 |
| EG001 | Rizatriptan 10 mg | Rizatriptan 10 mg orally once for treatment of single migraine attack | 0 | 455 | 254 | 455 |
| EG002 | Placebo | Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment | 0 | 307 | 83 | 307 |
| Migraine | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Pain, Abdominal | General disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Pain, Chest | General disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Alanine Amino Transferase (ALT) Increased | Investigations | CRISP Dictionary | Non-systematic Assessment |
|
| Aspartate Amino Transferase (AST) Increased | Investigations | CRISP Dictionary | Non-systematic Assessment |
|
| Tightness, Regional | Musculoskeletal and connective tissue disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Disorientation | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Hypesthesia | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Discomfort, Pharyngeal | Respiratory, thoracic and mediastinal disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Infection, Respiratory, Upper | Infections and infestations | CRISP Dictionary | Non-systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Hot Flashes | Reproductive system and breast disorders | CRISP Dictionary | Non-systematic Assessment |
|
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 |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Severely Impaired |
|
| Requires Bedrest |
|
|
| No pain relief |
|