Two Rizatriptan Prescribing Portions for Treatment of Migraine

This study has been completed.

Study NCT00397254 Information provided by Clinvest

First Received on November 7, 2006. Last Updated on June 7, 2010 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
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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
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 ]

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2. Secondary:

Number of Migraine Attacks [ Time Frame: 6 months ]

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3. Secondary:

Percentage of Responders [ Time Frame: 6 months ]

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4. Secondary:

Average Attack Duration [ Time Frame: 6 months ]

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

Adverse Experiences [ Time Frame: 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
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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