Non-chronic migraine with or without aura MedDRA version: 14.1 Level: HLT Classification code 10027603 Term: Migraine headaches System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: not available
Product Code: BGG492
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BGG492
CAS Number: 912574-69-7
Current Sponsor code: BGG492
Concentration unit: mg milligr
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the effects of BGG492 vs. placebo during the last 4-weeks treatment by - the mean change in number of migraine attacks compared to Baseline period. - number of days with migraine attacks compared to Baseline period - intensity (on a 0-3 Likert scale) and duration (in hours) of migraine headache compared to Baseline period. - the number of times acute migraine treatment is taken compared to Baseline period. To assess safety and tolerability of BGG492 in patients with non-chronic migraine attacks. To assess the effects of BGG492 on the quality of life using the migraine specific quality of life questionnaire v2.1 (MSQ v2.1). To assess the effects of BGG492 on the migraine-related disability using the migraine disability assessment questionnaire (MIDAS). ;Primary end point(s): Response 12-weeks after treatment initiation, defined as a 50% or greater reduction in attack frequency during the last 4 weeks of treatment compared with the baseline frequency (IHS Trial Guidelines).;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment;Main Objective: To assess the efficacy of BGG492 vs. placebo in terms of 50% responder rate (defined by = 50% reduction in attack frequency during the last 4-weeks of the 12-weeks treatment period compared with the 4-weeks Baseline period). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Baseline 2 to last dose intake in the number of migraine attacks over 4 weeks.;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment | — |
Countries
Germany, United Kingdom
Contacts
Public ContactMedical Competence Center
Novartis Pharma GmbH
Outcome results
None listed