Study to Test a Marketed Drug in the Treatment of Menstru... | NCT00111709

Studies
Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)

NCT00111709

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Aug 14, 2024Actual

Enrollment

393Actual

Phase

Phase 3

Conditions

Migraine

Interventions

MK0462, rizatriptan benzoate / Duration of Treatment -1 day
Comparator: placebo / Duration of Treatment - 1 day

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2005_024

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 27, 2005Actual

Primary Completion Date

Feb 24, 2006Actual

Completion Date

Feb 26, 2006Actual

First Submitted Date

May 24, 2005

First Submission Date that Met QC Criteria

May 24, 2005

First Posted Date

May 25, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2024

Last Update Posted Date

Aug 14, 2024Actual

Description Module

Brief Summary

The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

393Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK0462, rizatriptan benzoate / Duration of Treatment -1 day	Drug
Comparator: placebo / Duration of Treatment - 1 day	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patient at least 18 years old
Patient has menses approximately monthly
Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine

Exclusion Criteria:

Pregnant and/or nursing
Cardiovascular disease
Uncontrolled hypertension

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17448179	Background	Mannix LK, Loder E, Nett R, Mueller L, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007 May;27(5):414-21. doi: 10.1111/j.1468-2982.2007.01313.x.
18422606	Background

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
C093622	rizatriptan
D000081206	Duration of Therapy

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services