Proof of concept study in patients with non-chronic migraine to assess the safety, efficacy and tolerability of BGG492 in migraine preventio

• Conditions: on-chronic migraine with or without aura; MedDRA version: 14.1Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-005316-28-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-16
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- Male and female smoking and non-smoking subjects of 18 to 65 years of age (inclusive), with non-chronic migraine with or without aura of duration of at least 12 months prior to the Screening.
- Age of onset of episodic migraine no later than 50 years.
Note: Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Diagnosis of basilar, ophthalmoplegic or hemiplegic migraine as shown in the current/past medical history.
- Experience of non-migraine headaches on more than 6 days per 4 weeks in the past 6 months prior to Screening.
- Any psychiatric condition (e.g., schizophrenia, dementia, bipolar disorder) as shown in the past medical history at Screening which may put the patient at risk or interfere with efficacy assessments with exception of general anxiety disorder, major or minor depression, adjustment disorders.
- Pregnant or nursing (lactating) women. All female patients must have negative serum pregnancy test results at Screening and negative urine pregnancy test results at both Baselines (1 and 2).
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during Screening and both Baselines (1 and 2).
- History or presence of suicidal behaviour or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) in the past six (6) months or history of suicidality as assessed by the Investigator as assessed at Baseline 1.
Note: Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified