NCT00812006

Brief Summary

This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

March 24, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 27, 2011

Completed
Last Updated

May 23, 2024

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

December 17, 2008

Results QC Date

September 23, 2010

Last Update Submit

May 9, 2024

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Pain Relief (PR)

    Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.

    2 hours post dose

Secondary Outcomes (4)

  • Sustained Pain Relief (SPR)

    2 - 24 hours post dose

  • Pain Freedom (PF)

    2 hours post dose

  • Normal Rating of Functional Disability (NRFD)

    2 hours post dose

  • Treatment Satisfaction (TS)

    24 hours post dose

Study Arms (3)

A

EXPERIMENTAL

Treatment Sequence A: rizatriptan, rizatriptan, placebo

Drug: rizatriptan benzoateDrug: Comparator: placebo

B

EXPERIMENTAL

Sequence B: rizatriptan, placebo, rizatriptan

Drug: rizatriptan benzoateDrug: Comparator: placebo

C

EXPERIMENTAL

Sequence C: placebo, rizatriptan, rizatriptan

Drug: rizatriptan benzoateDrug: Comparator: placebo

Interventions

rizatriptan benzoateDRUG

rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack

Also known as: Maxalt
ABC
Comparator: placeboDRUG

Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack

ABC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month
  • Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis
  • Patient can distinguish between migraine and other types of headache
  • Patient agrees to remain abstinent or use effective birth control during the study

You may not qualify if:

  • Patient is pregnant or breast-feeding
  • Patient has a history of mostly mild migraines or migraines that resolve within 2 hours
  • Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening.
  • Patient was \> 50 years old at age of migraine onset
  • Patient has history of heart disease
  • Patient has uncontrolled hypertension
  • Patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers)
  • Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3 months of screening
  • Patient is taking more than one other migraine prophylactic medication
  • Patient has repeatedly failed to respond to or tolerate rizatriptan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Seeburger JL, Cady RK, Winner P, MacGregor A, Valade D, Ge Y, Zhang Y, Hustad CM, Strickler N, Schaefer E, Connor KM, Ho TW. Rizatriptan for treatment of acute migraine in patients taking topiramate for migraine prophylaxis. Headache. 2012 Jan;52(1):57-67. doi: 10.1111/j.1526-4610.2011.02027.x. Epub 2011 Nov 11.

    PMID: 22078129RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

rizatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@spcorp.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 19, 2008

Study Start

March 24, 2009

Primary Completion

October 22, 2009

Study Completion

October 22, 2009

Last Updated

May 23, 2024

Results First Posted

January 27, 2011

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share