Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0462-025 | |||
| 2009_590 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | Placebo-Rizatriptan-Rizatriptan-Rizatriptan |
|
| Treatment Sequence 2 | Experimental | Rizatriptan-Placebo-Rizatriptan-Rizatriptan |
|
| Treatment Sequence 3 | Experimental | Rizatriptan-Rizatriptan-Placebo-Rizatriptan |
|
| Treatment Sequence 4 | Experimental | Rizatriptan-Rizatriptan-Rizatriptan-Placebo |
|
| Treatment Sequence 5 | Experimental | Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rizatriptan benzoate | Drug | Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief at 2 Hours During the First Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief at 2 Hours During the Second Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack | 2 hours |
| Pain Relief at 2 Hours During the Third Migraine Attack Period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| 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. |
Not provided
Not provided
Patients screened at a pretreatment visit were given allocated drug supply with instructions. If by 2 months after screening, a patient still had not treated a migraine attack with test medication, he/she was to be discontinued from the study.
Patients were recruited at 23 sites in the United States.
First Patient Treated: April, 1995
Last Patient Treated: January 1996
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Rizatriptan/Rizatriptan/Rizatriptan | Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) |
| FG001 | Rizatriptan/Placebo/Rizatriptan/Rizatriptan | Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) |
| FG002 | Rizatriptan/Rizatriptan/Placebo/Rizatriptan | Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) |
| FG003 | Rizatriptan/Rizatriptan/Rizatriptan/Placebo | Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) |
| FG004 | Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan | Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Rizatriptan/Rizatriptan/Rizatriptan | Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) |
| BG001 | Rizatriptan/Placebo/Rizatriptan/Rizatriptan |
| 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 During the First Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack | The primary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. | Posted | Number | participants | 2 hours |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rizatriptan 10 mg | All Rizatriptan 10 mg patients from all Treatment Sequences |
Not provided
| 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 NCT00897949
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C093622 | rizatriptan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Comparator: Placebo | Drug | Placebo to Rizatriptan, Oral Tablet |
|
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack |
| 2 hours |
| Pain Relief at 2 Hours During the Fourth Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack | 2 hours |
| 9748025 | Result | Kramer MS, Matzura-Wolfe D, Polis A, Getson A, Amaraneni PG, Solbach MP, McHugh W, Feighner J, Silberstein S, Reines SA. A placebo-controlled crossover study of rizatriptan in the treatment of multiple migraine attacks. Rizatriptan Multiple Attack Study Group. Neurology. 1998 Sep;51(3):773-81. doi: 10.1212/wnl.51.3.773. |
| 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. |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Pregnancy |
|
| Patient Uncooperative |
|
| Abnormal Baseline ECG |
|
| No Longer Met Inc/Exc Criteria |
|
| Not Completed/Entered Extn |
|
| Study Terminated |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Pregnancy |
|
| Patient Uncooperative |
|
| Abnormal Prestudy Labs |
|
| Abnormal Baseline ECG |
|
| No Attack Pretreatment |
|
| No Longer Met Inc/Exc Criteria |
|
| Inc/Exc Criteria Not Met |
|
Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) |
| BG002 | Rizatriptan/Rizatriptan/Placebo/Rizatriptan | Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) |
| BG003 | Rizatriptan/Rizatriptan/Rizatriptan/Placebo | Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) |
| BG004 | Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan | Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Baseline Severity (First Attack) | Each patient rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) | Number | Participants |
|
All Placebo patients from all Treatment Sequences |
|
|
| Secondary | Pain Relief at 2 Hours During the Second Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack | The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next. | Posted | Number | Participants | 2 hours |
|
|
|
| Secondary | Pain Relief at 2 Hours During the Third Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack | The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next. | Posted | Number | Participants | 2 hours |
|
|
|
| Secondary | Pain Relief at 2 Hours During the Fourth Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack | The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next. | Posted | Number | Participants | 2 hours |
|
|
|
| 0 |
| 337 |
| 199 |
| 323 |
| EG001 | Placebo | All Placebo patients from all Treatment Sequences | 0 | 84 | 31 | 84 |
| Candidiasis | Infections and infestations | CRISP Dictionary | Non-systematic Assessment |
|
| Chills | General disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Fever | General disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Pain, Abdominal | General disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Pain, Chest | General disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Palpitation | Cardiac disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal 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 |
|
| Hypothyroidism | Endocrine disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Leukocytes Decreased | Blood and lymphatic system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Alanine Amino Transferase (ALT) Increased | Investigations | CRISP Dictionary | Non-systematic Assessment |
|
| Abnormal Sensation | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Euphoria | Psychiatric disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Hypesthesia | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Mental Acuity Decreased | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Nervousness | 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 |
|
| Dyspnea | 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 |
|
| Accommodation Disorder | General disorders | CRISP Dictionary | Non-systematic Assessment |
|
| Depth Perception Loss | Eye 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 |