Two Rizatriptan Prescribing Portions for Treatment of Migraine

This study has been completed.

Sponsor:

Collaborator:

Merck

Information provided by:

Clinvest

ClinicalTrials.gov Identifier:

NCT00397254

First received: November 7, 2006

Last updated: June 7, 2010

Last verified: September 2009

History of Changes

Results First Received: March 6, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Migraine
Intervention:	Drug: rizatriptan

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3-month Baseline Period occurred prior to randomization to Clinical Limit or Formulary Limit groups. 42 subjects discontinued from total enrollment of 197: (2) Adverse Event (AE), (10) Lost to Follow Up (LFU), (11) Withdrew consent, (1) Pregnancy, (16) Failed to meet Inclusion/Exclusion at Visit 4 Randomization, (2) Other

Reporting Groups

	Description
Rizatriptan 27 Tablets - Clinical Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.
Rizatriptan 9 Tablets - Formulary Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.

Participant Flow: Overall Study

	Rizatriptan 27 Tablets - Clinical Limit	Rizatriptan 9 Tablets - Formulary Limit
STARTED	79	76
COMPLETED	77	74
NOT COMPLETED	2	2
Lost to Follow-up	2	2

Baseline Characteristics

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Reporting Groups

	Description
Baseline Period - Rizatriptan 9 Tablets	Prior to randomization at Visit 2 (to rizatriptan 9 tablets or rizatriptan 27 tablets), all subjects in Baseline were provided with 9 tablets of rizatriptan.

Baseline Measures

	Baseline Period - Rizatriptan 9 Tablets
Number of Participants [units: participants]	197
Age [units: participants]
<=18 years	0
Between 18 and 65 years	197
>=65 years	0
Age [units: years] Mean ( Full Range )	42 ( 18 to 61 )
Gender [units: participants]
Female	173
Male	24
Region of Enrollment [units: participants]
United States	197

Outcome Measures

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1. Primary:

Number of Days With Migraine [ Time Frame: 6 months ]

Measure Type	Primary
Measure Title	Number of Days With Migraine
Measure Description	No text entered.
Time Frame	6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Reporting Groups

	Description
Rizatriptan 27 Tablets - Clinical Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.
Rizatriptan 9 Tablets - Formulary Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.

Measured Values

	Rizatriptan 27 Tablets - Clinical Limit	Rizatriptan 9 Tablets - Formulary Limit
Number of Participants Analyzed [units: participants]	77	74
Number of Days With Migraine [units: Days] Mean ± Standard Deviation	2.666 ± 1.297	2.738 ± 1.313

No statistical analysis provided for Number of Days With Migraine

2. Secondary:

Number of Migraine Attacks [ Time Frame: 6 months ]

Measure Type	Secondary
Measure Title	Number of Migraine Attacks
Measure Description	No text entered.
Time Frame	6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Reporting Groups

	Description
Rizatriptan 27 Tablets - Clinical Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.
Rizatriptan 9 Tablets - Formulary Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.

Measured Values

	Rizatriptan 27 Tablets - Clinical Limit	Rizatriptan 9 Tablets - Formulary Limit
Number of Participants Analyzed [units: participants]	77	74
Number of Migraine Attacks [units: Migraine attacks] Mean ± Standard Deviation	4.855 ± 2.093	4.399 ± 1.548

No statistical analysis provided for Number of Migraine Attacks

3. Secondary:

Percentage of Responders [ Time Frame: 6 months ]

Measure Type	Secondary
Measure Title	Percentage of Responders
Measure Description	Percentage of Responders (50% decrease in attack frequency) of Formulary Limit Group versus Percentage of Responders (50% decrease in attack frequency) in Clinical Limit Group
Time Frame	6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Reporting Groups

	Description
Rizatriptan 27 Tablets - Clinical Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.
Rizatriptan 9 Tablets - Formulary Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.

Measured Values

	Rizatriptan 27 Tablets - Clinical Limit	Rizatriptan 9 Tablets - Formulary Limit
Number of Participants Analyzed [units: participants]	77	74
Percentage of Responders [units: Percentage of Participants]	7.79	2.70

No statistical analysis provided for Percentage of Responders

4. Secondary:

Average Attack Duration [ Time Frame: 6 months ]

Measure Type	Secondary
Measure Title	Average Attack Duration
Measure Description	No text entered.
Time Frame	6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Reporting Groups

	Description
Rizatriptan 27 Tablets - Clinical Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.
Rizatriptan 9 Tablets - Formulary Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.

Measured Values

	Rizatriptan 27 Tablets - Clinical Limit	Rizatriptan 9 Tablets - Formulary Limit
Number of Participants Analyzed [units: participants]	77	74
Average Attack Duration [units: Hours] Mean ± Standard Deviation	11.569 ± 8.188	12.930 ± 9.192

No statistical analysis provided for Average Attack Duration

5. Secondary:

Headache Severity of All Attacks [ Time Frame: 6 months ]

Measure Type	Secondary
Measure Title	Headache Severity of All Attacks
Measure Description	4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)
Time Frame	6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Reporting Groups

	Description
Rizatriptan 27 Tablets - Clinical Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.
Rizatriptan 9 Tablets - Formulary Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.

Measured Values

	Rizatriptan 27 Tablets - Clinical Limit	Rizatriptan 9 Tablets - Formulary Limit
Number of Participants Analyzed [units: participants]	77	74
Headache Severity of All Attacks [units: Units on a scale] Median ( Full Range )	1.50 ( 1.00 to 2.76 )	1.59 ( 1.00 to 3.00 )

No statistical analysis provided for Headache Severity of All Attacks

6. Secondary:

Percentage of Attacks With Symptom Elimination at 2 Hours [ Time Frame: 6 months ]

Measure Type	Secondary
Measure Title	Percentage of Attacks With Symptom Elimination at 2 Hours
Measure Description	Percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Formulary Limit Group versus percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Clinical Limit Group
Time Frame	6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Reporting Groups

	Description
Rizatriptan 27 Tablets - Clinical Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.
Rizatriptan 9 Tablets - Formulary Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.

Measured Values

	Rizatriptan 27 Tablets - Clinical Limit	Rizatriptan 9 Tablets - Formulary Limit
Number of Participants Analyzed [units: participants]	77	74
Percentage of Attacks With Symptom Elimination at 2 Hours [units: Percentage of attacks]	58.35	56.60

No statistical analysis provided for Percentage of Attacks With Symptom Elimination at 2 Hours

7. Secondary:

Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose [ Time Frame: 6 months ]

Measure Type	Secondary
Measure Title	Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose
Measure Description	Percentage of attacks with mild, moderate or severely impaired ability to perform activities pre-treatment with return to normal function at 2 hours post-dose in Formulary Limit Group versus Clinical Limit Group
Time Frame	6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Reporting Groups

	Description
Rizatriptan 27 Tablets - Clinical Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.
Rizatriptan 9 Tablets - Formulary Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.

Measured Values

	Rizatriptan 27 Tablets - Clinical Limit	Rizatriptan 9 Tablets - Formulary Limit
Number of Participants Analyzed [units: participants]	77	74
Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose [units: Percentage of attacks]	50.74	48.67

No statistical analysis provided for Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose

8. Secondary:

Adverse Experiences [ Time Frame: 6 months ]

Measure Type	Secondary
Measure Title	Adverse Experiences
Measure Description	Participants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.
Time Frame	6 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Reporting Groups

	Description
Rizatriptan 27 Tablets - Clinical Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.
Rizatriptan 9 Tablets - Formulary Limit	Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.

Measured Values

	Rizatriptan 27 Tablets - Clinical Limit	Rizatriptan 9 Tablets - Formulary Limit
Number of Participants Analyzed [units: participants]	77	74
Adverse Experiences [units: Participants]	18	24

No statistical analysis provided for Adverse Experiences

Serious Adverse Events

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Other Adverse Events

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More Information

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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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Investigator is free to publish results of it's part of the study in collaboration with the other investigators subsequent to the multicenter publication issued by Clinvest. Principal Investigator (PI) may publish results of it's data with copy of any manuscript for review to Clinvest 60 days prior to submission for publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: M.E. Beach
Organization: Clinvest
phone: 417-841-3618
e-mail: mbeach@clinvest.com

Publications:

Brandes JL, Visser WH, Farmer MV, Schuhl AL, Malbecq W, Vrijens F, Lines CR, Reines SA; Protocol 125 study group. Montelukast for migraine prophylaxis: a randomized, double-blind, placebo-controlled study. Headache. 2004 Jun;44(6):581-6.

Publications automatically indexed to this study:

Cady RK, Goldstein J, Silberstein S, Juhász M, Ramsey K, Rodgers A, Hustad CM, Ho T. Expanding access to triptans: assessment of clinical outcome. Headache. 2009 Nov-Dec;49(10):1402-13. Epub 2009 Oct 8.

Responsible Party:	Roger K. Cady, MD, Clinvest
ClinicalTrials.gov Identifier:	NCT00397254 History of Changes
Other Study ID Numbers:	078-00
Study First Received:	November 7, 2006
Results First Received:	March 6, 2009
Last Updated:	June 7, 2010
Health Authority:	United States: Institutional Review Board

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