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Trial record 16 of 179 for:    Migraine AND migraine with or without aura

Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00443209
Recruitment Status : Completed
First Posted : March 5, 2007
Results First Posted : August 18, 2014
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Telcagepant 300 mg soft gel capsules Drug: Telcagepant 280 mg tablets Drug: Rizatriptan 10 mg tablets Drug: Placebo to telcagepant capsules Drug: Placebo to telcagepant tablets Drug: Placebo to rizatriptan tablets Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1068 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Active-Controlled, Parallel Group Study to Examine the Safety, Tolerability and Efficacy of Oral MK-0974 for the Long Term Treatment of Acute Migraine With or Without Aura
Actual Study Start Date : February 21, 2007
Actual Primary Completion Date : January 22, 2009
Actual Study Completion Date : January 22, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Rizatriptan

Arm Intervention/treatment
Experimental: 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.
Drug: Telcagepant 300 mg soft gel capsules
One capsule taken orally at onset of migraine

Drug: Telcagepant 280 mg tablets
One tablet taken orally at onset of migraine

Drug: Placebo to rizatriptan tablets
One tablet taken orally at onset of migraine

Active Comparator: 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.
Drug: Rizatriptan 10 mg tablets
One tablet taken orally at onset of migraine

Drug: Placebo to telcagepant capsules
One capsule taken orally at onset of migraine

Drug: Placebo to telcagepant tablets
One tablet taken orally at onset of migraine




Primary Outcome Measures :
  1. Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE) [ Time Frame: Within 14 days of any dose of study drug (Up to 18.5 months) ]
    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.

  2. Percentage of Participants With At Least One Clinical AE [ Time Frame: Within 14 days of any dose of study drug (Up to 18.5 months) ]
    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.

  3. Percentage of Participants With At Least One Laboratory AE [ Time Frame: Within 14 days of any dose of study drug (Up to 18.5 months) ]
    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.

  4. Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change [ Time Frame: Within 14 days of any dose of study drug (Up to 18.5 months) ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose (Up to 18 months) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 1 year history of migraine (with or without aura)
  • Females of child bearing potential must use acceptable contraception throughout trial
  • In general good health based on screening assessment

Exclusion Criteria:

  • Pregnant/breast-feeding (or is a female expecting to conceive during study period)
  • History or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
  • Major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
  • History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
  • History of cancer within the last 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443209


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00443209     History of Changes
Other Study ID Numbers: 0974-012
MK-0974-012 ( Other Identifier: Merck Protocol Number )
2006_524 ( Other Identifier: Telerx Study Number )
First Posted: March 5, 2007    Key Record Dates
Results First Posted: August 18, 2014
Last Update Posted: October 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs