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Completed

NCT Number: NCT00892203

Efficacy and Safety of BGG492 in the Treatment of Migraine

This study will assess the efficacy and safety of BGG492 used to treat migraine pain.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of moderate to severe migraine for at least 1 year
  • At least 1 migraine episode, but not more 15 migraine days per month
  • Past use of triptans
  • Migraine onset before 50 years of age

Exclusion criteria

  • Diagnosis of basilar, ophthalmoplegic or hemiplegic migraine.
  • More than 6 non-migraine headaches per month
  • Patients receiving migraine prophylaxis treatment
  • Patients receiving regular treatment with psychoactive drugs
  • Smokers
  • Patients with a very high or low body weight Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

BGG492

Drug

Sumatriptan

Drug

Placebo

Drug

Primary outcomes

  1. Reduction in migraine pain

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multi-centre, Randomized, Double-blind, Parallel Group, Active and Placebo Controlled, Proof of Concept Study in Patients With Acute Migraine to Assess the Efficacy, Safety and Tolerability of Single Oral Doses of BGG492

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 4, 2009
Registry last updated
Dec 17, 2020

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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