TerminatedNCT00820105Updated Dec 24, 2009

ADX10059 Migraine Prevention Study

A Phase 2 interventional study of ADX10059 and ADX10059 in Migraine, sponsored by Addex Pharma S.A.. Terminated at 31 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-12-24.

Sponsored by Addex Pharma S.A. · Phase 2, Interventional, and Prevention

Why this study was terminated

Incidence of abnormalities of liver function tests is higher than expected in this population.

Phase: Phase 2
Study type: Interventional
Enrollment: 350
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

Evaluation of ADX10059 to prevent migraine attacks

Conditions studied

Migraine

Browse trials for

Migraine Disorders 1,528

Keywords

Migraine
Aura
Migraine headache

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's planned enrollment of 350 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Addex Pharma S.A. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male and female patients aged 18 to 65 years
History of migraine
Aged ≤ 50 years at onset of migraine history

Exclusion criteria

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 design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 350 participants (estimated)

Study arms

Experimental
ADX10059 25 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
Drug: ADX10059
Experimental
ADX10059 50 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
Drug: ADX10059
Experimental
ADX10059 100 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
Drug: ADX10059
Placebo comparator
ADX10059 Matching Placebo
Weeks 1-2: once daily Weeks 3-12: twice daily
Drug: ADX10059 Matching Placebo

Interventions

DrugADX10059
oral administration
DrugADX10059
Oral administration
DrugADX10059
Oral administration
DrugADX10059 Matching Placebo
Oral administration

What researchers measure

Primary outcomes

Number of migraine headache days during weeks 9-12 of the treatment period
Time frame: 12 weeks

Secondary outcomes

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

Study locations

31 sites

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, 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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00820105
Lead sponsor: Addex Pharma S.A.
First posted: Jan 9, 2009
Start date: Dec 2008
Primary completion: Jan 2010 (estimated)
Last update: Dec 24, 2009

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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