ADX10059 Migraine Prevention Study

NCT ID: NCT00820105

Last Updated: 2009-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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Evaluation of ADX10059 to prevent migraine attacks

Detailed Description

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Conditions

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Migraine

Keywords

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Migraine Aura Migraine headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ADX10059 25 mg

Weeks 1-2: once daily Weeks 3-12: twice daily

Group Type EXPERIMENTAL

ADX10059

Intervention Type DRUG

oral administration

ADX10059 50 mg

Weeks 1-2: once daily Weeks 3-12: twice daily

Group Type EXPERIMENTAL

ADX10059

Intervention Type DRUG

Oral administration

ADX10059 100 mg

Weeks 1-2: once daily Weeks 3-12: twice daily

Group Type EXPERIMENTAL

ADX10059

Intervention Type DRUG

Oral administration

ADX10059 Matching Placebo

Weeks 1-2: once daily Weeks 3-12: twice daily

Group Type PLACEBO_COMPARATOR

ADX10059 Matching Placebo

Intervention Type DRUG

Oral administration

Interventions

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ADX10059

oral administration

Intervention Type DRUG

ADX10059

Oral administration

Intervention Type DRUG

ADX10059

Oral administration

Intervention Type DRUG

ADX10059 Matching Placebo

Oral administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Addex Pharma S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Addex Pharma SA

Locations

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Vienna, , Austria

Site Status

Liège

Liège, , Belgium

Site Status

Sint-Truiden

Sint-Truiden, , Belgium

Site Status

Wilrijk

Wilrijk, , Belgium

Site Status

Lille

Lille, , France

Site Status

Nice

Nice, , France

Site Status

Paris

Paris, , France

Site Status

Toulouse

Toulouse, , France

Site Status

06

Berlin, , Germany

Site Status

Berlin Hellersdorf 11

Berlin, , Germany

Site Status

Bochum

Bochum, , Germany

Site Status

Dreseden

Dresden, , Germany

Site Status

02

Essen, , Germany

Site Status

28

Essen, , Germany

Site Status

Frankfurt

Frankfurt, , Germany

Site Status

Freiburg

Freiburg im Breisgau, , Germany

Site Status

Göppingen

Göppingen, , Germany

Site Status

Görlitz

Görlitz, , Germany

Site Status

Hamburg

Hamburg, , Germany

Site Status

Itzehoe

Itzehoe, , Germany

Site Status

Leipzig

Leipzig, , Germany

Site Status

Magdeburg

Magdeburg, , Germany

Site Status

05

München, , Germany

Site Status

10

München, , Germany

Site Status

Münster

Münster, , Germany

Site Status

Wiesbaden

Wiesbaden, , Germany

Site Status

Berkshire

Berkshire, , United Kingdom

Site Status

Cardiff

Cardiff, , United Kingdom

Site Status

Liverpool

Liverpool, , United Kingdom

Site Status

24

London, , United Kingdom

Site Status

Manchester

Manchester, , United Kingdom

Site Status

Countries

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Austria Belgium France Germany United Kingdom

Other Identifiers

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2008-005481-30

Identifier Type: -

Identifier Source: secondary_id

ADX10059-206

Identifier Type: -

Identifier Source: org_study_id