Two Rizatriptan Prescribing Portions for Treatment of Migraine

This study has been completed.

Study NCT00397254 Information provided by Clinvest

First Received: November 7, 2006 Last Updated: September 17, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Investigator), Active Control, Parallel Assignment
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
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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 ]

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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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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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