MigrainePhase 2NCT01820559
Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine
A Phase 2 study testing ESL 1200 mg and ESL 800 mg in people with Migraine, run by Bial - Portela C S.A..
Trial summary
This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic treatment in subjects with migraine with or without aura. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- ESL 1200 mg and ESL 800 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 452 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women or men, 18 years of age or older (according to Amendment #1 for Czech Republic [24 Mar 2009]: 18 to 65 years of age).
- Diagnosis (established prior to 50 years of age) of migraine headaches for at least 1 year, and a well-documented history of migraine headaches with or without aura according to the criteria of the IHS (see Section 3.5.6.1) for at least 3 months (according to Amendment #1 for Czech Republic [24 Mar 2009]: for at least 3 months with at least 3 migraine attacks per month in each of these 3 months).
- At least 2 (according to Amendment #1 for Czech Republic [24 Mar 2009]: at least 3) (and no more than 10) well-defined migraine headache attacks per month, with at least 24 h of freedom from headaches and other symptoms of migraine between attacks.
- Able to distinguish the migraine headache attacks from other types of common headaches (tension-type headaches, sinus-related headaches, etc.).
- Not taking any prophylactic migraine therapies for at least 2 weeks prior to Baseline Visit (V2). Flunarizine had to be discontinued at least 4 weeks prior to V2.
- Able and willing to provide written informed consent to participate in the study after having the opportunity to review the Subject Information Sheet and Informed Consent Form (ICF).
- Able and willing to comply with all study requirements, in the judgment of the investigator.
- Women were surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or at least 2 years postmenopausal or, if of childbearing potential, were sexually abstinent or agreed to use medically acceptable non-hormonal methods of contraception (see Section 3.3.3). (According to Amendment #1 for Czech Republic [24 Mar 2009]: Women were sexually abstinent or agreed to use a double-barrier method of contraception. Hormonal contraceptives were not acceptable as a contraceptive method in this study. However, their intake was not forbidden throughout the study.)
Who cannot join
- A known hypersensitivity to ESL or to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine), or to any of the excipients.
- Suspected or confirmed medication-overuse headache.
- More than 14 headache days (migraine or other headache types) per month in either of the 2 months prior to screening.
- Consistent or recurrent frequent headaches (i.e. ≥6 headache days a month) other than migraine headaches.
- Unable to discontinue medications primarily used for migraine prophylaxis that have been commonly used for other indications (tricyclic agents, divalproic acid, topiramate, etc.). A subject who received beta blockers or calcium channel blocker therapy for reasons other than migraine prophylaxis was eligible for inclusion, provided his/her dosing regimen had been stable for ≥2 months and was not expected to change during the course of the study.
- Using prohibited concomitant medication (see Section 3.5.5.2).
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- A white blood cell (WBC) count <2.5 * 109/L, neutrophil count <1.5 * 109/L, sodium <125 mmol/L, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the upper limit of normal at V1 (Screening Visit), or any other clinically relevant laboratory abnormality that, in the investigator's opinion, could compromise the subject's safety.
- A creatinine clearance lower than 60 mL/min at screening.
- A second- or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator.
- Pregnant or nursing women.
- A history of chronic alcohol or drug abuse or addiction within the last 2 years.
- A severe hepatic, renal, respiratory, haematological, or immunologic illness, unstable cardiovascular disease, or any other medical or psychiatric condition that, in the judgment of the investigator, made the subject inappropriate for entry into this study.
- Received an investigational drug (or a medical device) within 3 months of screening or was currently participating in another study of an investigational drug (or medical device).
- An employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, or was a family member of the employees or the investigator.
About this study
Official title: Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine: a Doubleblind,Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic treatment in subjects with migraine with or without aura. Subjects were randomised in a 1:1:1 ratio to receive placebo, ESL 800 mg/day once daily (QD), or ESL 1200 mg/day QD.
Read the detailed description
The study consisted of a Screening Period of 2 to 4 weeks, a 4-week placebo Baseline Period, a 2-week Titration Period, a 12-week Maintenance Period, and a 4-week Follow-up Period. During the entire study the subjects had a diary to document the occurrence, duration, and intensity of headaches, the occurrence or not of aura and its nature, as well as other related symptoms, and the use of study medication and acute medication.
- Conditions
- Migraine
- Being tested
- Placebo, ESL 1200 mg, ESL 800 mg
- Keywords
- migraine; ESL; eslicarbazepine acetate
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sugar pills
Tablets
ESL 1200 mgDrug
Also called Eslicarbazepine acetate
Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route.
ESL 800 mgDrug
Also called Eslicarbazepine acetate
Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route.
| Study group | Role | What they receive |
|---|---|---|
| ESL 1200 mg | Active comparator | eslicarbazepine acetate 1200 mg Receives: Drug: ESL 1200 mg |
| ESL 800 mg | Active comparator | eslicarbazepine acetate 800 mg Receives: Drug: ESL 800 mg |
| Placebo | Placebo comparator | Placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in the Frequency of Migraine Attacks
The primary efficacy variable was the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the Maintenance Period, as recorded in the subject diary. If there were less than 24 h between the end of 1 migraine event and the start of the next event, these 2 events were considered to belong to 1 migraine attack. There had to be a minimum of 24 h of freedom from headache, pain, and symptoms of migraine between attacks recorded in the subject diary to be considered as more than 1 attack of migraine for statistical analysis.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startApr 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricio Soares-da-Silva, MD, PhD, Study director, BIAL - Portela & Ca. SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820559
- Sponsor's protocol ID
- BIA-2093-209
- Status last verified
- Apr 2013
- First submitted
- 26 Mar 2013
- Last updated
- 24 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine: a Doubleblind,Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT01820559
- Acronym / sponsor ID
- BIA-2093-209
- Conditions
- Migraine
- Keywords
- migraine; ESL; eslicarbazepine acetate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Posted 24 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic treatment in subjects with migraine with or without aura. Subjects were randomised in a 1:1:1 ratio to receive placebo, ESL 800 mg/day once daily (QD), or ESL 1200 mg/day QD.
Detailed description
The study consisted of a Screening Period of 2 to 4 weeks, a 4-week placebo Baseline Period, a 2-week Titration Period, a 12-week Maintenance Period, and a 4-week Follow-up Period. During the entire study the subjects had a diary to document the occurrence, duration, and intensity of headaches, the occurrence or not of aura and its nature, as well as other related symptoms, and the use of study medication and acute medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESL 1200 mg | Active comparator | Drug: ESL 1200 mgeslicarbazepine acetate 1200 mg |
| ESL 800 mg | Active comparator | Drug: ESL 800 mgeslicarbazepine acetate 800 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women or men, 18 years of age or older (according to Amendment #1 for Czech Republic [24 Mar 2009]: 18 to 65 years of age).
- Diagnosis (established prior to 50 years of age) of migraine headaches for at least 1 year, and a well-documented history of migraine headaches with or without aura according to the criteria of the IHS (see Section 3.5.6.1) for at least 3 months (according to Amendment #1 for Czech Republic [24 Mar 2009]: for at least 3 months with at least 3 migraine attacks per month in each of these 3 months).
- At least 2 (according to Amendment #1 for Czech Republic [24 Mar 2009]: at least 3) (and no more than 10) well-defined migraine headache attacks per month, with at least 24 h of freedom from headaches and other symptoms of migraine between attacks.
- Able to distinguish the migraine headache attacks from other types of common headaches (tension-type headaches, sinus-related headaches, etc.).
- Not taking any prophylactic migraine therapies for at least 2 weeks prior to Baseline Visit (V2). Flunarizine had to be discontinued at least 4 weeks prior to V2.
Key exclusion criteria (14 listed)
- A known hypersensitivity to ESL or to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine), or to any of the excipients.
- Suspected or confirmed medication-overuse headache.
- More than 14 headache days (migraine or other headache types) per month in either of the 2 months prior to screening.
- Consistent or recurrent frequent headaches (i.e. ≥6 headache days a month) other than migraine headaches.
- Unable to discontinue medications primarily used for migraine prophylaxis that have been commonly used for other indications (tricyclic agents, divalproic acid, topiramate, etc.). A subject who received beta blockers or calcium channel blocker therapy for reasons other than migraine prophylaxis was eligible for inclusion, provided his/her dosing regimen had been stable for ≥2 months and was not expected to change during the course of the study.
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 |
|---|---|---|
| PlaceboAlso: Sugar pillsTablets | Drug | Placebo |
| ESL 1200 mgAlso: Eslicarbazepine acetateEslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route. | Drug | ESL 1200 mg |
| ESL 800 mgAlso: Eslicarbazepine acetateEslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route. | Drug | ESL 800 mg |
Primary outcome
Absolute Change From Baseline in the Frequency of Migraine Attacks
Time frame: 4 weeks
The primary efficacy variable was the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the Maintenance Period, as recorded in the subject diary. If there were less than 24 h between the end of 1 migraine event and the start of the next event, these 2 events were considered to belong to 1 migraine attack. There had to be a minimum of 24 h of freedom from headache, pain, and symptoms of migraine between attacks recorded in the subject diary to be considered as more than 1 attack of migraine for statistical analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Patricio Soares-da-Silva, MD, PhD study director
BIAL - Portela & Ca. SA
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ESL 1200 mg and ESL 800 mg in people with Migraine, run by Bial - Portela C S.A..
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 8 inclusion and 14 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: finished, as of the sponsor's last update on 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 24 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Change From Baseline in the Frequency of Migraine Attacks (time frame: 4 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 May 2013.