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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_587 |
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A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence A | Experimental | Rizatriptan - Rizatriptan - Placebo |
|
| Treatment Sequence B | Experimental | Rizatriptan - Placebo - Rizatriptan |
|
| Treatment Sequence C | Experimental | Placebo - Rizatriptan - Rizatriptan |
|
| Baseline Phase | Other | Sumatriptan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rizatriptan | Drug | Single dose of 10 mg orally disintegrating tablet at onset of migraine attack |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief (PR) | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose. | 2 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Freedom (PF) | Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose. | 2 hours post dose |
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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 |
|---|---|---|---|
| 21078681 | Result | Seeburger JL, Taylor FR, Friedman D, Newman L, Ge Y, Zhang Y, Hustad CM, Lasorda J, Fan X, Hewitt D, Ho T, Connor KM. Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. Cephalalgia. 2011 May;31(7):786-96. doi: 10.1177/0333102410390399. Epub 2010 Nov 15. |
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Participants who met entry criteria but had evidence of suicidality or were severely depressed (based on
questionnaire scores) were excluded. Within 2 months of entry, participants were to treat a moderate/
severe migraine attack with sumatriptan 100 mg and were randomized if they still had moderate or severe
pain at 2 hours post-dose.
Patients were recruited at 21 study centers in the United States.
First Patient In: 10-Jun-2009;
First Patient Treated: 26-Jun-2009
Last Patient Last Visit: 12-Jan-2010;
Last Patient Treated: 25-Dec-2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Rizatriptan / Rizatriptan / Placebo | Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one with placebo. The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo. |
| FG001 | Rizatriptan / Placebo / Rizatriptan | Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one with placebo. The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT. |
| FG002 | Placebo / Rizatriptan / Rizatriptan | Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one with placebo. The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT |
| FG003 | Sumatriptan 100 mg | Pre-Randomization Phase conducted 2 months prior to Study Randomization. Eligible participants were to treat a moderate/severe migraine attack with sumatriptan 100 mg. Those who failed to respond to sumatriptan (i.e. continued to experience moderate or severe pain at 2 hours post dose) were classified as non-responders and were entered into the double-blind treatment phase of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Phase |
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| Treatment Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rizatriptan / Rizatriptan / Placebo | The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo. |
| BG001 | Rizatriptan / Placebo / 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 (PR) | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose. | The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point. | Posted | Number | attacks | 2 hours post dose | Evaluable Attacks | Evaluable Attacks |
|
Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Participants reported adverse events in a paper diary and were collected by the site at Visits 2 and 3, and 14 days after the last dose of study medication. AEs that occurred in the Baseline Phase (prior to randomization) are reported as a separate arm. Events not applicable to a particular Study Phase are reported as (0/0).
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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 10 mg | Patients took at least one dose of study medication. It is possible for one patient to be counted twice (once in each treatment group). Although a patient may have had two or more adverse events of the same type, the patient is counted only once for that type of adverse event. Adverse events occurring within 14 days of administration of Rizatriptan 10 mg are attributed to Rizatriptan 10 mg group even if placebo was administered more recently. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia - Baseline Phase | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| C093622 | rizatriptan |
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| Comparator: Placebo | Drug | Placebo to Rizatriptan |
|
| Comparator: Sumatriptan | Drug | single dose of generic sumatriptan 100 mg at onset of migraine attack |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT. |
| BG002 | Placebo / Rizatriptan / Rizatriptan | The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo | Migraines were treated with placebo |
|
|
|
| Secondary | Pain Freedom (PF) | Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose. | The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point. | Posted | Number | attacks | 2 hours post dose | Evaluable Attacks | Evaluable Attacks |
|
|
|
|
| 0 |
| 102 |
| 18 |
| 102 |
| EG001 | Placebo | 0 | 100 | 3 | 100 |
| EG002 | Sumatriptan 100 mg | Adverse Events that occurred in the Baseline Phase (prior to taking study medication) are identified in the tables as "Baseline Phase" | 0 | 194 | 29 | 194 |
|
| Motion Sickness - Baseline Phase | Ear and labyrinth disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Eyelid Pain - Baseline Phase | Eye disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Abdominal pain - Baseline Phase | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Abdominal pain upper - Baseline Phase | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Dry mouth - Baseline Phase | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Nausea - Baseline Phase | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Paraesthesia oral - Baseline Phase | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Asthenia - Baseline Phase | General disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Chest discomfort - Baseline Phase | General disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
|
| Fatigue - Baseline Phase | General disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
|
| Oedema peripheral - Baseline Phase | General disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
|
| Pain - Baseline Phase | General disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
|
| Hordeolum - Baseline Phase | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
|
| Nasopharyngitis - Baseline Phase | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Rhinitis - Baseline Phase | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
|
| Foot fracture - Baseline Phase | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Heart rate increased - Baseline Phase | Investigations | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Back pain - Baseline Phase | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Muscle spasms - Baseline Phase | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Muscle tightness - Baseline Phase | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Neck pain - Baseline Phase | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Cognitive disorder - Baseline Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Dizziness - Baseline Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Headache - Baseline Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Migraine - Baseline Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Paraesthesia - Baseline Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Sinus headache - Baseline Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Anxiety - Baseline Phase | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Insomnia - Baseline Phase | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Metrorrhagia - Baseline Phase | Reproductive system and breast disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Dyspnoea - Baseline Phase | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Throat tightness - Baseline Phase | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Hot flush - Baseline Phase | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment | Pre-Randomization reported Adverse Event |
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| Eyelid ptosis - Treatment Phase | Eye disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Vision blurred - Treatment Phase | Eye disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Abdominal pain upper - Treatment Phase | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Diarrhoea - Treatment Phase | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Nausea - Treatment Phase | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Fatigue - Treatment Phase | General disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Feeling of relaxation - Treatment Phase | General disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Gait disturbance - Treatment Phase | General disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Influenza like illness - Treatment Phase | General disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Sensation of pressure - Treatment Phase | General disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Facial bones fracture - Treatment Phase | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Wrist fracture - Treatment Phase | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Myokymia - Treatment Phase | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Melanocytic naevus - Treatment Phase | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Cognitive disorder - Treatment Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Dizziness - Treatment Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Dysgeusia - Treatment Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Paraesthesia - Treatment Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Sinus headache - Treatment Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Somnolence - Treatment Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Syncope - Treatment Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Insomnia - Treatment Phase | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
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| Hot flush - Treatment Phase | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment | Post-Randomization reported Adverse Event |
|
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.