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MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)

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ClinicalTrials.gov Identifier: NCT00797667
Recruitment Status : Terminated (The study was terminated based on a recommendation of the DSMB following the identification of two patients with significant elevations in serum transaminases)
First Posted : November 25, 2008
Results First Posted : September 8, 2014
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Telcagepant 140 mg
Drug: Telcagepant 280 mg
Drug: 140 mg telcagepant placebo
Drug: 280 mg telcagepant placebo
Enrollment 660
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Period Title: Overall Study
Started 265 264 131
Treated 263 263 130
Completed 5 5 4
Not Completed 260 259 127
Reason Not Completed
Lack of Efficacy             0             1             0
Lost to Follow-up             8             12             2
Physician Decision             3             1             0
Pregnancy             2             0             0
Protocol Violation             2             7             0
Study Terminated by Sponsor             217             216             115
Withdrawal by Subject             9             14             2
Adverse Event             19             8             8
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo Total
Hide Arm/Group Description Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 263 263 130 656
Hide Baseline Analysis Population Description
All enrolled participants who recieved at least one dose of study drug.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 263 participants 263 participants 130 participants 656 participants
< 20 years 2 3 2 7
20-29 years 54 47 17 118
30-39 years 52 70 43 165
40-49 years 81 80 32 193
50-59 years 66 50 30 146
60-64 years 7 10 2 19
>=65 years 1 3 4 8
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 263 participants 130 participants 656 participants
Female
223
  84.8%
216
  82.1%
112
  86.2%
551
  84.0%
Male
40
  15.2%
47
  17.9%
18
  13.8%
105
  16.0%
1.Primary Outcome
Title Change From Baseline in Mean Monthly Headache Days
Hide Description Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Overall Number of Participants Analyzed 248 247 125
Mean (95% Confidence Interval)
Unit of Measure: Days per month
-3.4
(-3.9 to -2.8)
-3.6
(-4.1 to -3.1)
-2.4
(-3.2 to -1.7)
2.Primary Outcome
Title Change From Baseline in Mean Monthly Migraine Days
Hide Description Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Overall Number of Participants Analyzed 248 247 125
Mean (95% Confidence Interval)
Unit of Measure: Days per month
-3.0
(-3.5 to -2.5)
-3.4
(-3.9 to -3.0)
-2.3
(-3.0 to -1.6)
3.Primary Outcome
Title Percentage of Participants Who Experienced an Adverse Event
Hide Description Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the 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 was temporally associated with the use of the product, was also an adverse event.
Time Frame up to 14 days after last dose of study drug (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Overall Number of Participants Analyzed 263 265 128
Measure Type: Number
Unit of Measure: Percentage of Participants
52.5 54.0 57.8
4.Primary Outcome
Title Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event
Hide Description Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the 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 was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Overall Number of Participants Analyzed 263 265 128
Measure Type: Number
Unit of Measure: Percentage of Participants
8.0 3.0 7.8
5.Secondary Outcome
Title Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days
Hide Description Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Overall Number of Participants Analyzed 248 247 125
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
36.7
(30.68 to 43.02)
40.1
(33.92 to 46.48)
25.6
(18.22 to 34.18)
6.Secondary Outcome
Title Change From Baseline in the Mean Monthly Migraine Attacks
Hide Description Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Overall Number of Participants Analyzed 248 247 125
Mean (95% Confidence Interval)
Unit of Measure: attacks per month
-2.1
(-2.4 to -1.7)
-2.5
(-2.8 to -2.2)
-1.7
(-2.2 to -1.2)
7.Secondary Outcome
Title Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication
Hide Description Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.
Arm/Group Title Telcagepant 140 mg Telcagepant 280 mg Placebo
Hide Arm/Group Description:
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Overall Number of Participants Analyzed 248 248 125
Mean (95% Confidence Interval)
Unit of Measure: Days per month
-3.0
(-3.5 to -2.5)
-3.2
(-3.7 to -2.8)
-1.7
(-2.4 to -1.0)
Time Frame up to 14 days after last dose of study drug (up to 12 weeks)
Adverse Event Reporting Description All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
 
Arm/Group Title MK-0974 140 mg MK-0974 280 mg Placebo
Hide Arm/Group Description Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
All-Cause Mortality
MK-0974 140 mg MK-0974 280 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
MK-0974 140 mg MK-0974 280 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/263 (1.52%)      3/265 (1.13%)      1/128 (0.78%)    
Gastrointestinal disorders       
Colonic atony  1  0/263 (0.00%)  0 1/265 (0.38%)  1 0/128 (0.00%)  0
Infections and infestations       
Labyrinthitis  1  0/263 (0.00%)  0 1/265 (0.38%)  1 0/128 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  0/263 (0.00%)  0 1/265 (0.38%)  1 0/128 (0.00%)  0
Aspartate aminotransferase increased  1  0/263 (0.00%)  0 1/265 (0.38%)  1 0/128 (0.00%)  0
Hepatic enzyme increased  1  1/263 (0.38%)  1 0/265 (0.00%)  0 0/128 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant melanoma  1  0/263 (0.00%)  0 0/265 (0.00%)  0 1/128 (0.78%)  1
Neoplasm malignant  1  0/263 (0.00%)  0 1/265 (0.38%)  1 0/128 (0.00%)  0
Nervous system disorders       
Cerebellar syndrome  1  1/263 (0.38%)  1 0/265 (0.00%)  0 0/128 (0.00%)  0
Coordination abnormal  1  1/263 (0.38%)  1 0/265 (0.00%)  0 0/128 (0.00%)  0
Migraine  1  1/263 (0.38%)  1 0/265 (0.00%)  0 0/128 (0.00%)  0
Speech disorder  1  1/263 (0.38%)  1 0/265 (0.00%)  0 0/128 (0.00%)  0
Psychiatric disorders       
Confusional state  1  1/263 (0.38%)  1 0/265 (0.00%)  0 0/128 (0.00%)  0
Vascular disorders       
Orthostatic hypotension  1  1/263 (0.38%)  1 0/265 (0.00%)  0 0/128 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-0974 140 mg MK-0974 280 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/263 (23.19%)      73/265 (27.55%)      30/128 (23.44%)    
Gastrointestinal disorders       
Diarrhoea  1  21/263 (7.98%)  26 9/265 (3.40%)  9 6/128 (4.69%)  6
Nausea  1  31/263 (11.79%)  42 37/265 (13.96%)  42 7/128 (5.47%)  10
General disorders       
Fatigue  1  11/263 (4.18%)  11 14/265 (5.28%)  14 11/128 (8.59%)  12
Infections and infestations       
Upper respiratory tract infection  1  6/263 (2.28%)  7 9/265 (3.40%)  10 12/128 (9.38%)  13
Nervous system disorders       
Dizziness  1  15/263 (5.70%)  26 16/265 (6.04%)  19 7/128 (5.47%)  13
Psychiatric disorders       
Insomnia  1  6/263 (2.28%)  8 6/265 (2.26%)  6 7/128 (5.47%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Based on a recommendation from the external Data Safety Monitoring Board (DSMB), a decision to terminate the trial was made on 26-Mar-2009.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00797667    
Other Study ID Numbers: 0974-049
2008_591
First Submitted: November 24, 2008
First Posted: November 25, 2008
Results First Submitted: August 13, 2014
Results First Posted: September 8, 2014
Last Update Posted: October 18, 2018