Phase IIb,randomised,double-blind,placebo-controlled,migraine

• Research type

  Research Study

• Full title

  A Phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multicentre study, to investigate the efficacy, safety and tolerability of the mGIuR5 negative allosteric modulator ADX10059 for the prevention of migraine.

• IRAS ID

  10968

• Contact name

  E Anne MacGregor

• Sponsor organisation

  Addex Pharma SA

• Eudract number

  2008-005481-30

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging multi-centre study in patients who have moderate or severe migraine attacks and who are not taking preventative migraine treatment. Approximately 350 patients, recruited at up to 35 study sites in Europe, may be screened in order to ensure 300 patients are randomised and 240 patients (60 per treatment group) complete the treatment period. Patient recruitment is anticipated to commence Q4 2008 and to complete Q3 2009. Patients will be randomised (1:1:1:1) to 1 of 4 treatment groups (25, 50 or 100 mg ADX10059 or matching placebo). In the first two weeks of study medication, patients will take study medication once daily. Upon satisfactory tolerability assessments conducted at the end of the second week, patients will take study medication twice daily for a further 10 weeks (to make a total treatment period of 12 weeks). Patients will attend the study site on a total of 7 occasions: Screening visit (4 weeks prior to treatment); Randomisation visit (Day 1 of treatment); Interim visits (weeks 2, 4 and 8); End of treatment visit (week 12); Follow-up visit (1 week after end of treatment). During the study, patients will record daily in a diary if they had migraine or not and the duration and intensity of their headache. In the visits at the clinic, the study physician will review the diary and evaluate how the patient is tolerating the study medication, patients will undergo routine safety tests (vital signs, blood testing, ECG, physical examination) and will complete questionnaires about their mood and the impact of their headache on daily life.The participation of each patient in the study (from Screening to last study assessment) may last up to 17 weeks: 4 weeks screening period, 12 weeks treatment period and 1 week follow-up period.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  08/H0709/83

• Date of REC Opinion

  20 Jan 2009

• REC opinion

  Further Information Favourable Opinion