NCT00894556CompletedPhase 3
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 109
- Primary Endpoint
- Pain Relief (PR)
Study Overview
Brief Summary
A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment Sequence A
Experimental
Rizatriptan - Rizatriptan - Placebo
Intervention: rizatriptan (Drug)
Treatment Sequence B
Experimental
Rizatriptan - Placebo - Rizatriptan
Intervention: rizatriptan (Drug)
Treatment Sequence C
Experimental
Placebo - Rizatriptan - Rizatriptan
Intervention: rizatriptan (Drug)
Outcomes
Primary Outcomes
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
- Pain Freedom (PF)(2 hours post dose)
Investigators
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