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Completed

NCT Number: NCT00894556

A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
  • Patient generally does not respond to treatment with sumatriptan
  • Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
  • Patient is able to complete paper diary

Exclusion criteria

  • Patient is pregnant or breast feeding or excepts to become pregnant during the study
  • Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
  • Patient has basilar or hemiplegic migraines
  • Patient is unable to distinguish between migraine attacks from other types of headaches
  • Patient has more than 15 headache-days per month
  • Patient was greater than 50 years old at age of migraine onset
  • Patient has failed to respond to 3 or more triptans
  • Patient has a repeated history of failing to respond to or tolerate rizatriptan
  • Patient uses opioids as primary migraine therapy
  • Patient uses daily opioids
  • Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
  • Patient has uncontrolled hypertension
  • Patient has a history of neoplastic disease
  • Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
  • Patient has a history of drug or alcohol abuse

Treatment and study plan

Rizatriptan

Drug

Single dose of 10 mg orally disintegrating tablet at onset of migraine attack

Comparator: placebo

Drug

Placebo to Rizatriptan

Comparator: Sumatriptan

Drug

single dose of generic sumatriptan 100 mg at onset of migraine attack

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg for the Treatment of Acute Migraine in Sumatriptan Non-Responders

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 7, 2009
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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