Clinical trial NCT00820105: ADX10059 Migraine Prevention Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Migraine
Keywords: Migraine
Aura
Migraine headache
Lead sponsor: Addex Pharma S.A.
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of ADX10059 to prevent migraine attacks


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 to 65 years
* History of migraine
* Aged ≤ 50 years at onset of migraine history

Exclusion Criteria:

* Cluster headache or chronic migraine headaches
* Currently uses, or within 3 months of Screening, has used: sodium valproate or topiramate and any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors
* Unable to distinguish migraine headache from tension and other types of headache
* Current history of psychiatric disorder requiring regular medication
* Known history of alcohol abuse
* Known clinically significant allergy or known hypersensitivity to drugs
* History of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
* Pregnant or breast-feeding

Primary outcomes:
measure: Number of migraine headache days during weeks 9-12 of the treatment period
timeFrame: 12 weeks
Secondary outcomes:
measure: Migraine frequency
timeFrame: 12 weeks
measure: Migraine severity
timeFrame: 12 weeks
measure: Migraine duration
timeFrame: 12 weeks
measure: Occurrence of aura
timeFrame: 12 weeks
measure: Functional impairment severity
timeFrame: 12 weeks
measure: Rescue medication use
timeFrame: 12 weeks
measure: Proportion of responders
timeFrame: 12 weeks
measure: Global assessment of study medication
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
city: Liège
country: Belgium
facility: Liège
city: Sint-Truiden
country: Belgium
facility: Sint-Truiden
city: Wilrijk
country: Belgium
facility: Wilrijk
city: Lille
country: France
facility: Lille
city: Nice
country: France
facility: Nice
city: Paris
country: France
facility: Paris
city: Toulouse
country: France
facility: Toulouse
city: Berlin
country: Germany
facility: 06
city: Berlin
country: Germany
facility: Berlin Hellersdorf 11
city: Bochum
country: Germany
facility: Bochum
city: Dresden
country: Germany
facility: Dreseden
city: Essen
country: Germany
facility: 02
city: Essen
country: Germany
facility: 28
city: Frankfurt
country: Germany
facility: Frankfurt
city: Freiburg
country: Germany
facility: Freiburg
city: Göppingen
country: Germany
facility: Göppingen
city: Görlitz
country: Germany
facility: Görlitz
city: Hamburg
country: Germany
facility: Hamburg
city: Itzehoe
country: Germany
facility: Itzehoe
city: Leipzig
country: Germany
facility: Leipzig
city: Magdeburg
country: Germany
facility: Magdeburg
city: München
country: Germany
facility: 05
city: München
country: Germany
facility: 10
city: Münster
country: Germany
facility: Münster
city: Wiesbaden
country: Germany
facility: Wiesbaden
city: Berkshire
country: United Kingdom
facility: Berkshire
city: Cardiff
country: United Kingdom
facility: Cardiff
city: Liverpool
country: United Kingdom
facility: Liverpool
city: London
country: United Kingdom
facility: 24
city: Manchester
country: United Kingdom
facility: Manchester
Study officials:
References: