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A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

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ClinicalTrials.gov Identifier: NCT00812006
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : January 27, 2011
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE December 17, 2008
First Posted Date  ICMJE December 19, 2008
Results First Submitted Date  ICMJE September 23, 2010
Results First Posted Date  ICMJE January 27, 2011
Last Update Posted Date June 6, 2017
Actual Study Start Date  ICMJE March 24, 2009
Actual Primary Completion Date October 22, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2011)
Pain Relief (PR) [ Time Frame: 2 hours post dose ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2008)
Efficacy of rizatriptan compared to placebo in treatment of acute migraine in patients on topiramate for migraine prophylaxis [ Time Frame: Pain relief (PR) at 2 hours post dose ]
Change History Complete list of historical versions of study NCT00812006 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2011)
  • Sustained Pain Relief (SPR) [ Time Frame: 2 - 24 hours post dose ]
    24-hour sustained pain relief (defined as pain relief at 2 hours post dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the respective period after dosing with the blinded study medication.
  • Pain Freedom (PF) [ Time Frame: 2 hours post dose ]
    Headache pain severity, relative to the administration of study medication, 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 freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.
  • Normal Rating of Functional Disability (NRFD) [ Time Frame: 2 hours post dose ]
    Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired, or unable to do activities, requires bedrest. Functional disability ratings was dichotomized to Normal and Not Normal (mildly impaired, severely impaired, or unable to do activities, requires bedrest) for analysis.
  • Treatment Satisfaction (TS) [ Time Frame: 24 hours post dose ]
    Patient satisfaction was assessed on a paper diary by the participants. Level of satisfaction was rated as: completely satisfied, very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied. The overall 24-hour assessment of study medication was dichotomized to Satisfaction (completely satisfied, very satisfied, somewhat satisfied) and Non-satisfaction (neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied) for analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2008)
Sustained Pain Relief (SPR) [ Time Frame: 2-24 hours post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: rizatriptan benzoate
    rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
    Other Name: Maxalt
  • Drug: Comparator: placebo
    Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack
Study Arms  ICMJE
  • Experimental: A
    Treatment Sequence A: rizatriptan, rizatriptan, placebo
    Interventions:
    • Drug: rizatriptan benzoate
    • Drug: Comparator: placebo
  • Experimental: B
    Sequence B: rizatriptan, placebo, rizatriptan
    Interventions:
    • Drug: rizatriptan benzoate
    • Drug: Comparator: placebo
  • Experimental: C
    Sequence C: placebo, rizatriptan, rizatriptan
    Interventions:
    • Drug: rizatriptan benzoate
    • Drug: Comparator: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2011)
108
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2008)
100
Actual Study Completion Date  ICMJE October 22, 2009
Actual Primary Completion Date October 22, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Spain,   United States
 
Administrative Information
NCT Number  ICMJE NCT00812006
Other Study ID Numbers  ICMJE 0462-085
2008_597
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP