Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00516737
• Collaborator: (none)
• Enrollment: 207
• Arms: 2
• Actual Duration (Months): 6.2

Study Details

Study Description

Brief Summary

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Comparator: rizatriptan benzoate; Drug: Comparator: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 207 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine
• Actual Study Start Date: Oct 3, 2007
• Actual Primary Completion Date: Apr 8, 2008
• Actual Study Completion Date: Apr 8, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Active Drug	Drug: Comparator: rizatriptan benzoate; Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack; Other Names: MK0462
Placebo Comparator: 2 Matching Pbo Comparator	Drug: Comparator: Placebo; Matching placebo; one dose, treatment of a single migraine attack

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Are Pain Free at 2 Hours Post-Dose [2 hours post-dose]

   Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.

Secondary Outcome Measures

1. Number of Participants With 24-Hour Sustained Pain Freedom [24 hours post-dose]

   24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.

2. Number of Participants With no Rescue Use up to 24 Hours Post-Dose [24 hours post-dose]

   Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.

3. Number of Participants With Absence of Photophobia at 2 Hours Post-dose [2 hours post-dose]

   Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.

4. Number of Participants With Absence of Phonophobia at 2 Hours Post-dose [2 hours post-dose]

   Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.

5. Number of Participants With Absence of Nausea at 2 Hours Post-dose [2 hours post-dose]

   Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.

6. Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose [2 hours post-dose]

   Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Greater than one year history of migraine

• Attacks typically mild when they begin and progress to moderate or severe

• Experience 1-4 migraine attacks per month

Exclusion Criteria:

• More than 15 headache days per month

• Heart disease

• Uncontrolled high blood pressure

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cady RK, Martin VT, Géraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00516737
• Other Study ID Numbers: 0462-081; 2007_547
• First Posted: Aug 15, 2007
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Migraine Disorders; Rizatriptan

Study Results

Participant Flow

Recruitment Details	Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany)
Pre-assignment Detail	Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.

Arm/Group Title	Rizatriptan 10 mg ODT	Placebo
Arm/Group Description	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Matching placebo; one dose, treatment of a single migraine attack
Period Title: Overall Study
STARTED	103	104
COMPLETED	92	96
NOT COMPLETED	11	8

Baseline Characteristics

Arm/Group Title	Rizatriptan 10 mg ODT	Placebo	Total
Arm/Group Description	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Matching placebo; one dose, treatment of a single migraine attack	Total of all reporting groups
Overall Participants	103	104	207
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	41	44	42.5
Sex: Female, Male (Count of Participants)
Female	90 87.4%	96 92.3%	186 89.9%
Male	13 12.6%	8 7.7%	21 10.1%
Race/Ethnicity, Customized (participants) [Number]
Black or African American	4 3.9%	3 2.9%	7 3.4%
White	95 92.2%	100 96.2%	195 94.2%
Asian	2 1.9%	1 1%	3 1.4%
Multi-Racial	2 1.9%	0 0%	2 1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Are Pain Free at 2 Hours Post-Dose
Description	Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.
Time Frame	2 hours post-dose

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

Arm/Group Title	Rizatriptan 10 mg ODT	Placebo
Arm/Group Description	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Matching placebo; one dose, treatment of a single migraine attack
Measure Participants	92	96
Number [Participants]	61 59.2%	27 26%

2. Secondary Outcome

Title	Number of Participants With 24-Hour Sustained Pain Freedom
Description	24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.
Time Frame	24 hours post-dose

Outcome Measure Data

Analysis Population Description

The FAS population was used for this secondary variable of 24-hour sustained pain freedom, unless participants were otherwise identified as non-responders for this endpoint (i.e., took rescue up to 24 hours post-dose or were not pain free at 2 hours post-dose). To be included, participants must have also had a non-missing 24-hour assessment.

Arm/Group Title	Rizatriptan 10 mg ODT	Placebo
Arm/Group Description	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Matching placebo; one dose, treatment of a single migraine attack
Measure Participants	92	96
Number [Participants]	48 46.6%	17 16.3%

3. Secondary Outcome

Title	Number of Participants With no Rescue Use up to 24 Hours Post-Dose
Description	Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.
Time Frame	24 hours post-dose

Outcome Measure Data

Analysis Population Description

The FAS population included all randomized and treated participants.

Arm/Group Title	Rizatriptan 10 mg ODT	Placebo
Arm/Group Description	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Matching placebo; one dose, treatment of a single migraine attack
Measure Participants	92	96
Number [Participants]	61 59.2%	32 30.8%

4. Secondary Outcome

Title	Number of Participants With Absence of Photophobia at 2 Hours Post-dose
Description	Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.
Time Frame	2 hours post-dose

Outcome Measure Data

Analysis Population Description

The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

Arm/Group Title	Rizatriptan 10 mg ODT	Placebo
Arm/Group Description	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Matching placebo; one dose, treatment of a single migraine attack
Measure Participants	92	96
Number [Participants]	69 67%	43 41.3%

5. Secondary Outcome

Title	Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
Description	Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.
Time Frame	2 hours post-dose

Outcome Measure Data

Analysis Population Description

The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

Arm/Group Title	Rizatriptan 10 mg ODT	Placebo
Arm/Group Description	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Matching placebo; one dose, treatment of a single migraine attack
Measure Participants	92	96
Number [Participants]	72 69.9%	55 52.9%

6. Secondary Outcome

Title	Number of Participants With Absence of Nausea at 2 Hours Post-dose
Description	Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.
Time Frame	2 hours post-dose

Outcome Measure Data

Analysis Population Description

The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

Arm/Group Title	Rizatriptan 10 mg ODT	Placebo
Arm/Group Description	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Matching placebo; one dose, treatment of a single migraine attack
Measure Participants	92	96
Number [Participants]	82 79.6%	73 70.2%

7. Secondary Outcome

Title	Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
Description	Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.
Time Frame	2 hours post-dose

Outcome Measure Data

Analysis Population Description

The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

Arm/Group Title	Rizatriptan 10 mg ODT	Placebo
Arm/Group Description	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack	Matching placebo; one dose, treatment of a single migraine attack
Measure Participants	92	96
Number [Participants]	66 64.1%	42 40.4%

Adverse Events

Arm/Group Title	Rizatriptan 10 mg ODT		Placebo
Arm/Group Description	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack		Matching placebo; one dose, treatment of a single migraine attack
All Cause Mortality
	Rizatriptan 10 mg ODT		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Rizatriptan 10 mg ODT		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/92 (0%)		0/96 (0%)
Other (Not Including Serious) Adverse Events
	Rizatriptan 10 mg ODT		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/92 (6.5%)		3/96 (3.1%)
Gastrointestinal disorders
Hyperchlorhydria	2/92 (2.2%)		0/96 (0%)
Nausea	1/92 (1.1%)		0/96 (0%)
General disorders
Fatigue	0/92 (0%)		1/96 (1%)
Feeling cold	0/92 (0%)		1/96 (1%)
Feeling jittery	1/92 (1.1%)		0/96 (0%)
Pain	1/92 (1.1%)		0/96 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	1/92 (1.1%)		0/96 (0%)
Nervous system disorders
Balance disorder	1/92 (1.1%)		0/96 (0%)
Dizziness	2/92 (2.2%)		1/96 (1%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/92 (0%)		1/96 (1%)
Throat tightness	1/92 (1.1%)		0/96 (0%)

Limitations/Caveats

In the Adverse Events section, all non-serious adverse experiences reported are post-treatment, up to the time of taking rescue medication or 14 days post-dose, whichever comes first.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.