ADX10059 Migraine Prevention Study

December 23, 2009 updated by: Addex Pharma S.A.

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

Evaluation of ADX10059 to prevent migraine attacks

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
  • Belgium
      • Liège, Belgium
        • Liège
      • Sint-Truiden, Belgium
        • Sint-Truiden
      • Wilrijk, Belgium
        • Wilrijk
  • France
      • Lille, France
        • Lille
      • Nice, France
        • Nice
      • Paris, France
        • Paris
      • Toulouse, France
        • Toulouse
  • Germany
      • Berlin, Germany
        • 06
      • Berlin, Germany
        • Berlin Hellersdorf 11
      • Bochum, Germany
        • Bochum
      • Dresden, Germany
        • Dreseden
      • Essen, Germany
        • 02
      • Essen, Germany
        • 28
      • Frankfurt, Germany
        • Frankfurt
      • Freiburg, Germany
        • Freiburg
      • Göppingen, Germany
        • Göppingen
      • Görlitz, Germany
        • Görlitz
      • Hamburg, Germany
        • Hamburg
      • Itzehoe, Germany
        • Itzehoe
      • Leipzig, Germany
        • Leipzig
      • Magdeburg, Germany
        • Magdeburg
      • München, Germany
        • 05
      • München, Germany
        • 10
      • Münster, Germany
        • Munster
      • Wiesbaden, Germany
        • Wiesbaden
  • United Kingdom
      • Berkshire, United Kingdom
        • Berkshire
      • Cardiff, United Kingdom
        • Cardiff
      • Liverpool, United Kingdom
        • Liverpool
      • London, United Kingdom
        • 24
      • Manchester, United Kingdom
        • Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADX10059 25 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
Drug: ADX10059
oral administration
Drug: ADX10059
Oral administration
Experimental: ADX10059 50 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
Drug: ADX10059
oral administration
Drug: ADX10059
Oral administration
Experimental: ADX10059 100 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
Drug: ADX10059
oral administration
Drug: ADX10059
Oral administration
Placebo Comparator: ADX10059 Matching Placebo
Weeks 1-2: once daily Weeks 3-12: twice daily
Drug: ADX10059 Matching Placebo
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of migraine headache days during weeks 9-12 of the treatment period
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Migraine frequency
Time Frame: 12 weeks
12 weeks
Migraine severity
Time Frame: 12 weeks
12 weeks
Migraine duration
Time Frame: 12 weeks
12 weeks
Occurrence of aura
Time Frame: 12 weeks
12 weeks
Functional impairment severity
Time Frame: 12 weeks
12 weeks
Rescue medication use
Time Frame: 12 weeks
12 weeks
Proportion of responders
Time Frame: 12 weeks
12 weeks
Global assessment of study medication
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addex Pharma S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 24, 2009

Last Update Submitted That Met QC Criteria

December 23, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX10059-206
  • 2008-005481-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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