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A Randomized,Double Blind, Placebo Controlled Study to Assess Efficacy,Safety and Tolerability of BGG492 in Migraine Prevention (')

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01617941
First received: June 10, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

It will provide a first evaluation of efficacy, safety and tolerability of BGG492 in patients with non-chronic migraine having more than 3 and less than 12 migraine attacks per 4 weeks.


Condition Intervention Phase
Patients With Migraine Equal of /More Than 3 and Equal of/ Less Than 12 Migraine Attacks/4 Weeks for Each of the Last 6 Months Preceding the Screening
 Drug: BGG492
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Parallel Group, Placebo Controlled, Study in Patients With Non-chronic Migraine to Assess the Efficacy, Safety and Tolerability of BID Oral Doses of BGG492 in Migraine Prevention.

Resource links provided by NLM:

MedlinePlus related topics: Migraine
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Frequency of migraine attacks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    50% responder rate (equal to or more than 50 % reduction in attack frequency during the last 4-weeks of the 12-weeks treatment period compared with the 4-weeks Baseline period)


Secondary Outcome Measures:
  • Number of migraine attacks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Mean change in number of migraine attacks comparing the last 4-weeks treatment with the Baseline period.


Enrollment: 90
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGG492
At Baseline 60 patients will be randomized to receive BGG492 for the upcoming 12 weeks (dose: 75 mg BID administered in approx. 12 hours +/- 2 hours intervals).
 Drug: BGG492
Placebo Comparator: Placebo
At Baseline 30 patients will be randomized to receive Placebo for the upcoming 12 weeks (matching a dose of 75 mg BID BGG492 administered in approx. 12 hours +/- 2 hours intervals).
 Drug: Placebo
In patients not tolerating a dose of 75 mg BID BGG492/Placebo the dose can be decreased to 50 mg BID and this dose will be continued for the rest of the planned treatment. Those patients who are not tolerating 50 mg BID BGG492/Placebo will be discontinued from the trial.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female smoking and non-smoking subjects of 18 to 65 years of age (inclusive)
  • Patients diagnosed with non-chronic migraine with or without aura of duration of at least 12 months prior to the study start
  • Patient diagnosed with migraine (according to the International Headache Society categories 1.1 and with equal to/more than 3 and equal to/ less than 12 migraine attacks per 4 weeks for each of the last 6 months preceding the Screening
  • Patients willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance

Exclusion Criteria:

  • Patients diagnosed with basilar, ophthalmoplegic or hemiplegic migraine as shown in the current/past medical history.
  • Patients having an experience of non-migraine headaches on more than 6 days per 4 weeks in the past 6 months prior to study start
  • Patients receiving regular treatment during the four (4) weeks preceding the Baseline with psychoactive drugs (e.g. hypnotics, benzodiazepines, neuroleptics) except antidepressants (eg. SSRIs, SNRIs, Tri- or Tetracyclics).
  • Patients receiving migraine prevention medications during past three (3) months preceding Baseline
  • Patients receiving topiramate as migraine prevention medication during past six (6) months preceding Baseline
  • Patients receiving metamizole as acute treatment of migraine during past three (3) months preceding Baseline
  • Patients using (or having used within four (4) weeks before the treatment start) drug treatments that are potent inhibitors of OATP transporters (e.g. rifampin).
  • Any psychiatric condition (e.g., schizophrenia, dementia, bipolar disorder) as shown in the past medical history prior to study start
  • Patients with recent (within the last three [3] years prior to study start) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, orthostatic hypotension etc.).
  • Pregnant or nursing (lactating) women. Baselines (1 and 2).
  • Patients with history of drug or alcohol abuse within the 12 months prior to dosing Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617941

Locations
Germany
Novartis Investigative Site
Berlin, Germany, 14050
Novartis Investigative Site
Berlin, Germany, 10117
United Kingdom
Novartis Investigative Site
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Novartis Investigative Site
Mid Glamorgan, United Kingdom, CF484DR
Novartis Investigative Site
Watford Road Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01617941     History of Changes
Other Study ID Numbers: CBGG492A2214, 2011-005316-28
Study First Received: June 10, 2012
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
non-chronic migraine, migraine prevention

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013