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Trial record 21 of 179 for:    Migraine AND migraine with or without aura

A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

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: NCT00894556
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : January 20, 2011
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acute Migraine
Interventions Drug: rizatriptan
Drug: Comparator: Placebo
Drug: Comparator: Sumatriptan
Enrollment 109
Recruitment Details

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

Pre-assignment Details

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.

Arm/Group Title Rizatriptan / Rizatriptan / Placebo Rizatriptan / Placebo / Rizatriptan Placebo / Rizatriptan / Rizatriptan Sumatriptan 100 mg
Hide Arm/Group Description

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.

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.

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

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.
Period Title: Baseline Phase
Started 0 0 0 194
Completed 0 0 0 109
Not Completed 0 0 0 85
Reason Not Completed
Did not meet Randomization Criteria             0             0             0             85
Period Title: Treatment Phase
Started 37 [1] 36 [1] 36 [1] 0
Completed 33 [2] 32 [2] 35 [2] 0
Not Completed 4 4 1 0
Reason Not Completed
Lost to Follow-up             2             3             1             0
Lack of Qualifying Event             2             1             0             0
[1]
Participants who were randomized into the treatment phase
[2]
Participants who treated 3 acute migraine attacks with study medication during the treatment phase
Arm/Group Title Rizatriptan / Rizatriptan / Placebo Rizatriptan / Placebo / Rizatriptan Placebo / Rizatriptan / Rizatriptan Total
Hide Arm/Group Description 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. The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT. The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT Total of all reporting groups
Overall Number of Baseline Participants 37 36 36 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 36 participants 36 participants 109 participants
42.2  (13.4) 43.6  (8.9) 43.5  (10.2) 43.1  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 36 participants 109 participants
Female
32
  86.5%
33
  91.7%
30
  83.3%
95
  87.2%
Male
5
  13.5%
3
   8.3%
6
  16.7%
14
  12.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 36 participants 109 participants
Hispanic or Latino
3
   8.1%
1
   2.8%
2
   5.6%
6
   5.5%
Not Hispanic or Latino
34
  91.9%
35
  97.2%
34
  94.4%
103
  94.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 36 participants 109 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   2.8%
1
   0.9%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  10.8%
4
  11.1%
3
   8.3%
11
  10.1%
White
31
  83.8%
31
  86.1%
30
  83.3%
92
  84.4%
More than one race
2
   5.4%
1
   2.8%
2
   5.6%
5
   4.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Pain Relief (PR)
Hide Description 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.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rizatriptan Placebo
Hide Arm/Group Description:

Migraines were treated with Rizatriptan 10 mg ODT.

Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups.

Migraines were treated with placebo
Overall Number of Participants Analyzed 102 99
Overall Number of Units Analyzed
Type of Units Analyzed: Evaluable Attacks
202 99
Measure Type: Number
Unit of Measure: attacks
Resulting in PR at 2 hours post dose 102 21
Not resulting in PR at 2 hours post dose 100 78
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rizatriptan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized Linear Mixed Model (GLIMMIX)
Comments An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.
2.Secondary Outcome
Title Pain Freedom (PF)
Hide Description 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.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rizatriptan Placebo
Hide Arm/Group Description:

Migraines were treated with Rizatriptan 10 mg ODT.

Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups.

Migraines were treated with placebo
Overall Number of Participants Analyzed 102 99
Overall Number of Units Analyzed
Type of Units Analyzed: Evaluable Attacks
202 99
Measure Type: Number
Unit of Measure: attacks
Resulting in PF at 2 hours post dose 46 12
Not resulting in PF at 2 hours post dose 156 87
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rizatriptan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized Linear Mixed Model (GLIMMIX)
Comments An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.
Time Frame Adverse events were collected from the time that participants were enrolled (signed informed consent) through 14 days after the last dose of study medication.
Adverse Event Reporting Description 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).
 
Arm/Group Title Rizatriptan 10 mg Placebo Sumatriptan 100 mg
Hide Arm/Group Description

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.

[Not Specified] Adverse Events that occurred in the Baseline Phase (prior to taking study medication) are identified in the tables as "Baseline Phase"
All-Cause Mortality
Rizatriptan 10 mg Placebo Sumatriptan 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rizatriptan 10 mg Placebo Sumatriptan 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)   0/100 (0.00%)   0/194 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rizatriptan 10 mg Placebo Sumatriptan 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/102 (17.65%)   3/100 (3.00%)   29/194 (14.95%) 
Cardiac disorders       
Tachycardia - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Ear and labyrinth disorders       
Motion Sickness - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Eye disorders       
Eyelid Pain - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Eyelid ptosis - Treatment Phase * 1 [2]  0/102 (0.00%)  1/100 (1.00%)  0/0 
Vision blurred - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Gastrointestinal disorders       
Abdominal pain - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Abdominal pain upper - Baseline Phase * 1 [1]  0/0  0/0  2/194 (1.03%) 
Dry mouth - Baseline Phase * 1 [1]  0/0  0/0  2/194 (1.03%) 
Nausea - Baseline Phase * 1 [1]  0/0  0/0  4/194 (2.06%) 
Paraesthesia oral - Baseline Phase * 1 [1]  0/0  0/0  2/194 (1.03%) 
Abdominal pain upper - Treatment Phase * 1 [2]  2/102 (1.96%)  1/100 (1.00%)  0/0 
Diarrhoea - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Nausea - Treatment Phase * 1 [2]  4/102 (3.92%)  0/100 (0.00%)  0/0 
General disorders       
Asthenia - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Chest discomfort - Baseline Phase * 1 [1]  0/0  0/0  3/194 (1.55%) 
Fatigue - Baseline Phase * 1 [1]  0/0  0/0  2/194 (1.03%) 
Oedema peripheral - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Pain - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Fatigue - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Feeling of relaxation - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Gait disturbance - Treatment Phase * 1 [2]  0/102 (0.00%)  1/100 (1.00%)  0/0 
Influenza like illness - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Sensation of pressure - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Infections and infestations       
Hordeolum - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Nasopharyngitis - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Rhinitis - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Injury, poisoning and procedural complications       
Foot fracture - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Facial bones fracture - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Wrist fracture - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Investigations       
Heart rate increased - Baseline Phase * 1 [1]  0/0  0/0  2/194 (1.03%) 
Musculoskeletal and connective tissue disorders       
Back pain - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Muscle spasms - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Muscle tightness - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Neck pain - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Myokymia - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Melanocytic naevus - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Nervous system disorders       
Cognitive disorder - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Dizziness - Baseline Phase * 1 [1]  0/0  0/0  9/194 (4.64%) 
Headache - Baseline Phase * 1 [1]  0/0  0/0  3/194 (1.55%) 
Migraine - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Paraesthesia - Baseline Phase * 1 [1]  0/0  0/0  3/194 (1.55%) 
Sinus headache - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Cognitive disorder - Treatment Phase * 1 [2]  0/102 (0.00%)  1/100 (1.00%)  0/0 
Dizziness - Treatment Phase * 1 [2]  4/102 (3.92%)  1/100 (1.00%)  0/0 
Dysgeusia - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Paraesthesia - Treatment Phase * 1 [2]  2/102 (1.96%)  1/100 (1.00%)  0/0 
Sinus headache - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Somnolence - Treatment Phase * 1 [2]  2/102 (1.96%)  0/100 (0.00%)  0/0 
Syncope - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Insomnia - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
Psychiatric disorders       
Anxiety - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Insomnia - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Reproductive system and breast disorders       
Metrorrhagia - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Throat tightness - Baseline Phase * 1 [1]  0/0  0/0  2/194 (1.03%) 
Vascular disorders       
Hot flush - Baseline Phase * 1 [1]  0/0  0/0  1/194 (0.52%) 
Hot flush - Treatment Phase * 1 [2]  1/102 (0.98%)  0/100 (0.00%)  0/0 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.1)
[1]
Pre-Randomization reported Adverse Event
[2]
Post-Randomization reported Adverse Event
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.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00894556     History of Changes
Other Study ID Numbers: 0462-087
2009_587
First Submitted: May 5, 2009
First Posted: May 7, 2009
Results First Submitted: September 23, 2010
Results First Posted: January 20, 2011
Last Update Posted: June 20, 2017