Two Rizatriptan Prescribing Portions for Treatment of Migraine - Study Results

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Investigator), Active Control, Parallel Assignment
Condition:	Migraine
Intervention:	Drug: rizatriptan

Participant Flow

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
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.
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

	Clinical Limit	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	No text entered.

Baseline Measures

	Baseline
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 (Formulary Limit Group Versus Clinical Limit Group) [ 6 months ]

Show Outcome Measure 1

2. Secondary:

Number of Migraine Attacks (Formulary Limit Group Versus Clinical Limit Group) [ 6 months ]

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3. Secondary:

Percentage of Responders (Formulary Limit Group Versus Clinical Limit Group) [ 6 months ]

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Measure Type	Secondary
Measure Title	Percentage of Responders (Formulary Limit Group Versus Clinical Limit Group)
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.
Baseline Period enrollment = 197. 42/197 discontinued (2 AE, 10 LFU, 11 Withdrew consent, 1 Pregnancy, 16 Failed to meet entry criteria at randomization visit, 2 Other). 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
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.
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

	Clinical Limit	Formulary Limit
Number of Participants Analyzed [units: participants]	77	74
Percentage of Responders (Formulary Limit Group Versus Clinical Limit Group) [units: Percentage of Participants]	7.79	2.70

No statistical analysis provided for Percentage of Responders (Formulary Limit Group Versus Clinical Limit Group)

4. Secondary:

Average Attack Duration (Formulary Limit Group Versus Clinical Limit Group) [ 6 months ]

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5. Secondary:

Headache Severity of All Attacks (Formulary Limit Group Versus Clinical Limit Group) [ 6 months ]

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6. Secondary:

Percentage of Attacks Wtih Symptom Elimination at 2 Hours (Formulary Limit Group Versus Clinical Limit Group) [ 6 months ]

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7. Secondary:

Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose (Formulary Limit Group Versus Clinical Limit Group) [ 6 months ]

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8. Secondary:

Adverse Experiences (Formulary Limit Group Versus Clinical Limit Group) [ 6 months ]

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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:	Clinvest ( Roger K. Cady, MD )
Study ID Numbers:	078-00
Study First Received:	November 7, 2006
Results First Received:	March 6, 2009
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00397254 History of Changes
Health Authority:	United States: Institutional Review Board