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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443209
• Other study ID #: 0974-012
• Secondary ID: MK-0974-0122006_
• Status: Completed
• Phase: Phase 3
• Start date: February 21, 2007
• Est. completion date: January 22, 2009

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1068
• Est. completion date: January 22, 2009
• Est. primary completion date: January 22, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Telcagepant 300 mg soft gel capsules
One capsule taken orally at onset of migraine
• Telcagepant 280 mg tablets
One tablet taken orally at onset of migraine
• Rizatriptan 10 mg tablets
One tablet taken orally at onset of migraine
• Placebo to telcagepant capsules
One capsule taken orally at onset of migraine
• Placebo to telcagepant tablets
One tablet taken orally at onset of migraine
• Placebo to rizatriptan tablets
One tablet taken orally at onset of migraine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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.1526-4610.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	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.	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.	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.	2 hours post-dose (Up to 18 months)