Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea

Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.

Completed

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

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

6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month

Exclusion criteria

Heart disease, high blood pressure

Treatment and study plan

Comparator: Rizatriptan

Drug

One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.

Comparator: placebo

Drug

One dose matching placebo to Rizatriptan to treat one migraine attack.

Primary outcomes

Participants With Elimination of Nausea at 2 Hours Postdose

Time frame: At 2 hours after treatment

Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.

Secondary outcomes

Participants With Pain Relief at 2 Hours Postdose

Time frame: 2 hours after treatment

Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Elimination of Migraine-Associated Nausea in Migraine Patients Treated With Rizatriptan Orally Disintegrating Tablet (ODT)

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Nov 8, 2005
Registry last updated: Feb 3, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed