Back to resultsADX10059 Migraine Prevention Study
Primary Purpose
Migraine
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ADX10059
ADX10059
ADX10059
ADX10059 Matching Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Migraine focused on measuring Migraine, Aura, Migraine headache
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
Sites / Locations
- Liège
- Sint-Truiden
- Wilrijk
- Lille
- Nice
- Paris
- Toulouse
- 06
- Berlin Hellersdorf 11
- Bochum
- Dreseden
- 02
- 28
- Frankfurt
- Freiburg
- Göppingen
- Görlitz
- Hamburg
- Itzehoe
- Leipzig
- Magdeburg
- 05
- 10
- Münster
- Wiesbaden
- Berkshire
- Cardiff
- Liverpool
- 24
- Manchester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ADX10059 25 mg
ADX10059 50 mg
ADX10059 100 mg
ADX10059 Matching Placebo
Arm Description
Weeks 1-2: once daily Weeks 3-12: twice daily
Weeks 1-2: once daily Weeks 3-12: twice daily
Weeks 1-2: once daily Weeks 3-12: twice daily
Weeks 1-2: once daily Weeks 3-12: twice daily
Outcomes
Primary Outcome Measures
Number of migraine headache days during weeks 9-12 of the treatment period
Secondary Outcome Measures
Migraine frequency
Migraine severity
Migraine duration
Occurrence of aura
Functional impairment severity
Rescue medication use
Proportion of responders
Global assessment of study medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00820105
Brief Title
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
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
Incidence of abnormalities of liver function tests is higher than expected in this population.
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Addex Pharma S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of ADX10059 to prevent migraine attacks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Aura, Migraine headache
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ADX10059 25 mg
Arm Type
Experimental
Arm Description
Weeks 1-2: once daily Weeks 3-12: twice daily
Arm Title
ADX10059 50 mg
Arm Type
Experimental
Arm Description
Weeks 1-2: once daily Weeks 3-12: twice daily
Arm Title
ADX10059 100 mg
Arm Type
Experimental
Arm Description
Weeks 1-2: once daily Weeks 3-12: twice daily
Arm Title
ADX10059 Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Weeks 1-2: once daily Weeks 3-12: twice daily
Intervention Type
Drug
Intervention Name(s)
ADX10059
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
ADX10059
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
ADX10059
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
ADX10059 Matching Placebo
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Number of migraine headache days during weeks 9-12 of the treatment period
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Migraine frequency
Time Frame
12 weeks
Title
Migraine severity
Time Frame
12 weeks
Title
Migraine duration
Time Frame
12 weeks
Title
Occurrence of aura
Time Frame
12 weeks
Title
Functional impairment severity
Time Frame
12 weeks
Title
Rescue medication use
Time Frame
12 weeks
Title
Proportion of responders
Time Frame
12 weeks
Title
Global assessment of study medication
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Vienna
Country
Austria
Facility Name
Liège
City
Liège
Country
Belgium
Facility Name
Sint-Truiden
City
Sint-Truiden
Country
Belgium
Facility Name
Wilrijk
City
Wilrijk
Country
Belgium
Facility Name
Lille
City
Lille
Country
France
Facility Name
Nice
City
Nice
Country
France
Facility Name
Paris
City
Paris
Country
France
Facility Name
Toulouse
City
Toulouse
Country
France
Facility Name
06
City
Berlin
Country
Germany
Facility Name
Berlin Hellersdorf 11
City
Berlin
Country
Germany
Facility Name
Bochum
City
Bochum
Country
Germany
Facility Name
Dreseden
City
Dresden
Country
Germany
Facility Name
02
City
Essen
Country
Germany
Facility Name
28
City
Essen
Country
Germany
Facility Name
Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Freiburg
City
Freiburg
Country
Germany
Facility Name
Göppingen
City
Göppingen
Country
Germany
Facility Name
Görlitz
City
Görlitz
Country
Germany
Facility Name
Hamburg
City
Hamburg
Country
Germany
Facility Name
Itzehoe
City
Itzehoe
Country
Germany
Facility Name
Leipzig
City
Leipzig
Country
Germany
Facility Name
Magdeburg
City
Magdeburg
Country
Germany
Facility Name
05
City
München
Country
Germany
Facility Name
10
City
München
Country
Germany
Facility Name
Münster
City
Münster
Country
Germany
Facility Name
Wiesbaden
City
Wiesbaden
Country
Germany
Facility Name
Berkshire
City
Berkshire
Country
United Kingdom
Facility Name
Cardiff
City
Cardiff
Country
United Kingdom
Facility Name
Liverpool
City
Liverpool
Country
United Kingdom
Facility Name
24
City
London
Country
United Kingdom
Facility Name
Manchester
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
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ADX10059 Migraine Prevention Study
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