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ADX10059 Migraine Prevention Study

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ClinicalTrials.gov Identifier: NCT00820105
Recruitment Status : Terminated (Incidence of abnormalities of liver function tests is higher than expected in this population.)
First Posted : January 9, 2009
Last Update Posted : December 24, 2009
Sponsor:
Information provided by:
Addex Pharma S.A.

Study Description
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Brief Summary:
Evaluation of ADX10059 to prevent migraine attacks

Condition or disease Intervention/treatment Phase
Migraine Drug: ADX10059 Drug: ADX10059 Matching Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : December 2008
Estimated Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: ADX10059 25 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
 Drug: ADX10059
oral administration
Experimental: ADX10059 50 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
 Drug: ADX10059
Oral administration
Experimental: ADX10059 100 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of migraine headache days during weeks 9-12 of the treatment period [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Migraine frequency [ Time Frame: 12 weeks ]
  2. Migraine severity [ Time Frame: 12 weeks ]
  3. Migraine duration [ Time Frame: 12 weeks ]
  4. Occurrence of aura [ Time Frame: 12 weeks ]
  5. Functional impairment severity [ Time Frame: 12 weeks ]
  6. Rescue medication use [ Time Frame: 12 weeks ]
  7. Proportion of responders [ Time Frame: 12 weeks ]
  8. Global assessment of study medication [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820105


Locations
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Sponsors and Collaborators
Addex Pharma S.A.
More Information
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Responsible Party: Study Director, Addex Pharma SA
ClinicalTrials.gov Identifier: NCT00820105    
Other Study ID Numbers: ADX10059-206
2008-005481-30
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: December 2009
Keywords provided by Addex Pharma S.A.:
Migraine
Aura
Migraine headache
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases