EUCTR2008-005481-30-FR
Active, not recruiting
Not Applicable
A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multicentre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 for the prevention of migraine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Addex Pharma SA
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A patient will be invited to participate if he/she meets the following inclusion criteria:
- •1\. is willing and able to provide written informed consent
- •2\. is male or female and aged 18 to 65 years, inclusive
- •3\. has a history of migraine, with or without aura for at least 1 year according to the
- •International Headache Society (IHS) diagnostic criteria
- •4\. was aged \= 50 years at onset of migraine history
- •5\. has an historical migraine attack frequency of \= 2 moderate/severe (IHS Grade
- •2/3\) attacks per month in the previous 3\-6 months
- •6\. has \= 3 moderate/severe (IHS Grade 2/3\) migraine attacks or 5 migraine
- •headache days in the 4 week baseline period, as confirmed from the eDiary data
Exclusion Criteria
- •A patient will be excluded from study participation if he/she meets any of the
- •following criteria:
- •1\. suffers from cluster headaches or chronic migraine headaches
- •2\. currently uses, or within 3 months of Screening, has used:
- •a. sodium valproate or topiramate
- •b. any other drugs used specifically for migraine prophylaxis, for example
- •beta\-blockers, calcium channel blockers, tricyclic antidepressants
- •(TCAs), selective serotonin reuptake inhibitors (SSRIs)
- •3\. has a total of \> 10 headache days requiring treatment with a triptan or \> 15
- •headache days, irrespective of whether any treatment is required (including nonsteroidal
Outcomes
Primary Outcomes
Not specified
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