Study assessing safety and tolerability BGG492 in migraine prevention

• Research type

  Research Study

• Full title

  "A multi-centre, randomised, 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"

• IRAS ID

  98486

• Contact name

  Muna Albyaty

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2011-005316-28

• Research summary

  Migraine is one of the primary headache disorders causing distress to 10-15% of the general population. Migraine attacks can be Acute, Episodic (most prominent) or Chronic. Three percent of all migraineurs develop chronic migraine, defined as >15 attacks/4weeks. The factors that trigger the attack frequency are not fully known, however, genetic predisposition and the chronic use of acute medication are thought to play a part. Prophylactic therapies aimed at reducing the frequency, intensity and duration of an attack and also reducing the need for acute therapy to lower attack frequency are urgently required. Current migraine prophylaxis such as beta-blockers - propranolol, antidepressants - amitryptilin and anticonvulsants - valporate and topiramate are effective, but the benefits of these medications need to be counterweighted by their poor adverse event profile and the contraindications. Effective prophylactic treatment of migraine is therefore of a high unmet medical need. Research has shown that hyperexcitability of the central nervous system could be a potential cause of migraine and increased release of glutamate appears to be involved in the onset and continuation of migraine. AMPA and kainate receptors are expressed at key synapses in the migraine pain pathway, and preclinical evidence suggests a potential benefit of an AMPA receptor antagonist such as BGG492 in migraine prophylaxis. This has been supported by clinical evidence for a prolonged effect in an acute migraine study investigating a single dose of BGG492. This is a multi-centre study conducted in up to 8 sites in the UK and Germany. The purpose of the study is to establish the proof of concept of BGG492 in migraine prevention. It will provide a first evaluation of efficacy, safety and tolerability of BGG492 in patients with non-chronic migraine who are experiencing >3 and <12 migraine attacks per 4 weeks.

• REC name

  Scotland A REC

• REC reference

  12/SS/0050

• Date of REC Opinion

  8 May 2012

• REC opinion

  Further Information Favourable Opinion