Study Stopped
Incidence of abnormalities of liver function tests is higher than expected in this population.
ADX10059 Migraine Prevention Study
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
2 other identifiers
interventional
350
5 countries
31
Brief Summary
Evaluation of ADX10059 to prevent migraine attacks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedDecember 24, 2009
December 1, 2009
1.1 years
January 8, 2009
December 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of migraine headache days during weeks 9-12 of the treatment period
12 weeks
Secondary Outcomes (8)
Migraine frequency
12 weeks
Migraine severity
12 weeks
Migraine duration
12 weeks
Occurrence of aura
12 weeks
Functional impairment severity
12 weeks
- +3 more secondary outcomes
Study Arms (4)
ADX10059 25 mg
EXPERIMENTALWeeks 1-2: once daily Weeks 3-12: twice daily
ADX10059 50 mg
EXPERIMENTALWeeks 1-2: once daily Weeks 3-12: twice daily
ADX10059 100 mg
EXPERIMENTALWeeks 1-2: once daily Weeks 3-12: twice daily
ADX10059 Matching Placebo
PLACEBO COMPARATORWeeks 1-2: once daily Weeks 3-12: twice daily
Interventions
Eligibility Criteria
You may qualify if:
- Male and female patients aged 18 to 65 years
- History of migraine
- Aged ≤ 50 years at onset of migraine history
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Unknown Facility
Vienna, Austria
Liège
Liège, Belgium
Sint-Truiden
Sint-Truiden, Belgium
Wilrijk
Wilrijk, Belgium
Lille
Lille, France
Nice
Nice, France
Paris
Paris, France
Toulouse
Toulouse, France
06
Berlin, Germany
Berlin Hellersdorf 11
Berlin, Germany
Bochum
Bochum, Germany
Dreseden
Dresden, Germany
02
Essen, Germany
28
Essen, Germany
Frankfurt
Frankfurt, Germany
Freiburg
Freiburg im Breisgau, Germany
Göppingen
Göppingen, Germany
Görlitz
Görlitz, Germany
Hamburg
Hamburg, Germany
Itzehoe
Itzehoe, Germany
Leipzig
Leipzig, Germany
Magdeburg
Magdeburg, Germany
05
München, Germany
10
München, Germany
Münster
Münster, Germany
Wiesbaden
Wiesbaden, Germany
Berkshire
Berkshire, United Kingdom
Cardiff
Cardiff, United Kingdom
Liverpool
Liverpool, United Kingdom
24
London, United Kingdom
Manchester
Manchester, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 9, 2009
Study Start
December 1, 2008
Primary Completion
January 1, 2010
Last Updated
December 24, 2009
Record last verified: 2009-12