Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-0974-012 | Other Identifier | Merck Protocol Number | |
| 2006_524 | Other Identifier | Telerx Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telcagepant 280 mg/300 mg | Experimental | Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months. |
|
| Rizatriptan 10 mg | Active Comparator | Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telcagepant 300 mg soft gel capsules | Drug | One capsule taken orally at onset of migraine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE) | Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug. | Within 14 days of any dose of study drug (Up to 18.5 months) |
| Percentage of Participants With At Least One Clinical AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug. | Within 14 days of any dose of study drug (Up to 18.5 months) |
| Percentage of Participants With At Least One Laboratory AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug. | Within 14 days of any dose of study drug (Up to 18.5 months) |
| Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change | Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (>=180 mm Hg and 20 mm Hg increase OR <=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (>=105 mm Hg and 15 mm Hg increase OR <=50 mm Hg and 15 mm Hg decrease), Pulse (>=120 beats per minute [bpm] and 15 bpm increase OR <=50 bpm and 15 bpm decrease), Body Temperature (>38º C [oral equivalent]) and Respiratory Rate (>25 or increase of 10 OR <5 or decrease of 10 [per minute]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose | Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from mild, moderate or severe migraine headache (Grade 1, 2, or 3) at baseline to no pain (Grade 0) 2 hours post-dose. | 2 hours post-dose (Up to 18 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21070230 | Result | Connor KM, Aurora SK, Loeys T, Ashina M, Jones C, Giezek H, Massaad R, Williams-Diaz A, Lines C, Ho TW. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial. Headache. 2011 Jan;51(1):73-84. doi: 10.1111/j.1526-4610.2010.01799.x. Epub 2010 Nov 10. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
Not provided
Not provided
Not provided
The trial was considered to have achieved completion as defined by the treatment of 100 participants for 12 months.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telcagepant 280 mg/300 mg | Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Months 1 to 12 Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Telcagepant 280 mg tablets | Drug | One tablet taken orally at onset of migraine |
|
| Rizatriptan 10 mg tablets | Drug | One tablet taken orally at onset of migraine |
|
| Placebo to telcagepant capsules | Drug | One capsule taken orally at onset of migraine |
|
| Placebo to telcagepant tablets | Drug | One tablet taken orally at onset of migraine |
|
| Placebo to rizatriptan tablets | Drug | One tablet taken orally at onset of migraine |
|
| Within 14 days of any dose of study drug (Up to 18.5 months) |
| FG001 | Rizatriptan 10 mg | Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Months 13 to 18 Treatment Period |
|
|
Baseline Analyis Population consisted of All Treated Participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telcagepant 280 mg/300 mg | Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months. |
| BG001 | Rizatriptan 10 mg | Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE) | Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug. | The All-Patients-As-Treated (APAT) population consisted of all participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | Within 14 days of any dose of study drug (Up to 18.5 months) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With At Least One Clinical AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug. | The APAT population consisted of all participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | Within 14 days of any dose of study drug (Up to 18.5 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With At Least One Laboratory AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug. | The APAT population consisted of all participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | Within 14 days of any dose of study drug (Up to 18.5 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change | Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (>=180 mm Hg and 20 mm Hg increase OR <=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (>=105 mm Hg and 15 mm Hg increase OR <=50 mm Hg and 15 mm Hg decrease), Pulse (>=120 beats per minute [bpm] and 15 bpm increase OR <=50 bpm and 15 bpm decrease), Body Temperature (>38º C [oral equivalent]) and Respiratory Rate (>25 or increase of 10 OR <5 or decrease of 10 [per minute]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug. | The APAT population consisted of all participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | Within 14 days of any dose of study drug (Up to 18.5 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose | Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from mild, moderate or severe migraine headache (Grade 1, 2, or 3) at baseline to no pain (Grade 0) 2 hours post-dose. | The Full Analysis Set (FAS) population consisted of all participants who were randomized and reported at least one treated migraine attack with at least one post-treatment efficacy evaluation. | Posted | Mean | Standard Deviation | Percentage of Migraine Attacks | 2 hours post-dose (Up to 18 months) |
|
Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received 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 | Telcagepant 280 mg/300 mg | Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months. | 12 | 641 | 187 | 641 | ||
| EG001 | Rizatriptan 10 mg | Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months. | 6 | 313 | 127 | 313 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Chondromalacia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Patellofemoral pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Sqamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C525458 | telcagepant |
| C093622 | rizatriptan |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Trial Terminated |
|
| Withdrawal by Subject |
|
| Male |
|
|
|
|
|
|
|
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
|
|
|
|