MigrainePhase 2NCT00820105
ADX10059 Migraine Prevention Study
A Phase 2 study testing ADX10059 in people with Migraine, run by Addex Pharma S.A. at 31 sites in 5 countries.
Trial summary
Evaluation of ADX10059 to prevent migraine attacks Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- ADX10059
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 31 sitesin 5 countries
- Study dates
- Dec 2008to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 to 65 years
- History of migraine
- Aged ≤ 50 years at onset of migraine history
Who cannot join
- 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
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
Germany18 sites
06
Berlin
Berlin Hellersdorf 11
Berlin
Bochum
Bochum
Dreseden
Dresden
02
Essen
28
Essen
Frankfurt
Frankfurt
Freiburg
Freiburg im Breisgau
Göppingen
Göppingen
Görlitz
Görlitz
Hamburg
Hamburg
Itzehoe
Itzehoe
Leipzig
Leipzig
Magdeburg
Magdeburg
05
München
10
München
Münster
Münster
Wiesbaden
Wiesbaden
United Kingdom5 sites
Berkshire
Berkshire
Cardiff
Cardiff
Liverpool
Liverpool
24
London
Manchester
Manchester
About this 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
Evaluation of ADX10059 to prevent migraine attacks
- Conditions
- Migraine
- Being tested
- ADX10059, ADX10059 Matching Placebo
- Keywords
- Migraine, Aura, Migraine headache
- Medical subject headings
- Migraine Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX10059Drug
oral administration
ADX10059Drug
Oral administration
ADX10059Drug
Oral administration
ADX10059 Matching PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| ADX10059 25 mg | Experimental | Weeks 1-2: once daily Weeks 3-12: twice daily Receives: Drug: ADX10059 |
| ADX10059 50 mg | Experimental | Weeks 1-2: once daily Weeks 3-12: twice daily Receives: Drug: ADX10059 |
| ADX10059 100 mg | Experimental | Weeks 1-2: once daily Weeks 3-12: twice daily Receives: Drug: ADX10059 |
| ADX10059 Matching Placebo | Placebo comparator | Weeks 1-2: once daily Weeks 3-12: twice daily Receives: Drug: ADX10059 Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of migraine headache days during weeks 9-12 of the treatment period
Measured: 12 weeks
Secondary outcomes (8)
Migraine frequency
Measured: 12 weeks
Migraine severity
Measured: 12 weeks
Migraine duration
Measured: 12 weeks
Occurrence of aura
Measured: 12 weeks
Functional impairment severity
Measured: 12 weeks
Rescue medication use
Measured: 12 weeks
Proportion of responders
Measured: 12 weeks
Global assessment of study medication
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2010 (estimated)
Why it stopped: Incidence of abnormalities of liver function tests is higher than expected in this population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addex Pharma S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820105
- Sponsor's protocol ID
- ADX10059-206
- Other IDs
- 2008-005481-30, 2008
- Status last verified
- Dec 2009
- First submitted
- 8 Jan 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00820105
- Acronym / sponsor ID
- ADX10059-206
- Conditions
- Migraine
- Keywords
- Migraine, Aura, Migraine headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Incidence of abnormalities of liver function tests is higher than expected in this population.
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Addex Pharma S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (estimated)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of ADX10059 to prevent migraine attacks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADX10059 25 mg | Experimental | Drug: ADX10059Weeks 1-2: once daily Weeks 3-12: twice daily |
| ADX10059 50 mg | Experimental | Drug: ADX10059Weeks 1-2: once daily Weeks 3-12: twice daily |
| ADX10059 100 mg | Experimental | Drug: ADX10059Weeks 1-2: once daily Weeks 3-12: twice daily |
| ADX10059 Matching Placebo | Placebo comparator | Drug: ADX10059 Matching PlaceboWeeks 1-2: once daily Weeks 3-12: twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients aged 18 to 65 years
- History of migraine
- Aged ≤ 50 years at onset of migraine history
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX10059oral administration | Drug | ADX10059 25 mg |
| ADX10059Oral administration | Drug | ADX10059 50 mg |
| ADX10059Oral administration | Drug | ADX10059 100 mg |
| ADX10059 Matching PlaceboOral administration | Drug | ADX10059 Matching Placebo |
Primary outcome
Number of migraine headache days during weeks 9-12 of the treatment period
Time frame: 12 weeks
8 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
Results and safety
The study was stopped early (reason given: Incidence of abnormalities of liver function tests is higher than expected in this population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
Related trials for Migraine
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
RecruitingObservational study
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Migraine
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADX10059 in people with Migraine, run by Addex Pharma S.A. at 31 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Germany, United Kingdom, France, Belgium, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Incidence of abnormalities of liver function tests is higher than expected in this population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of migraine headache days during weeks 9-12 of the treatment period (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.