Migraine With AuraPhase 3NCT00334178
Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
A Phase 3 study testing Laxymig ER (drug) in people with Migraine With Aura and Migraine Without Aura, run by Lotus Pharmaceutical at 7 sites in Taiwan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with placebo in prophylactic monotherapy treatment of migraine headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura
- What is being tested?
- Laxymig ER (drug)
- How many people
- 74 participants
- Where
- 7 sitesTaiwan
- Study dates
- Nov 2004to Sep 2006
- Phase
- Phase 3
- 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
- Clinical diagnosis of migraine with or without aura (typical aura with migraine headache)
- Subjects who had an average of two or more migraine frequencies per month during the 3 months before screening
Who cannot join
- Female subjects who are pregnant, lactating
- Chronic daily headache
- Previous treatment with three or more migraine prophylaxis medications failed
- Subjects with hepatic disease whose liver enzymes are over 2 times of upper limit of reference or significant dysfunction
- Coexisting medical, neurological, or psychiatric disorder that may hinder the study according to the investigator's judgment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites
Changhua Christian Hospital
Changhua
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City
Chang-Gung Memorial Hospital
Linkou District
Chinese Medical University Hospital
Taichung
SinLau Christian Hospital
Tainan
Taipei Veterans General Hospital
Taipei, 112
Taipei Medical University Hospital
Taipei
About this study
Official title: A Multi-Center, Randomized, Parallel, Double-Blind, Placebo-Controlled Study in Evaluation the Efficacy and Safety of Laxymig® ER as Prophylactic Treatment in Patients With Migraine
The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with placebo in prophylactic monotherapy treatment of migraine headache.
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with placebo in prophylactic monotherapy treatment of migraine headache.
Four weeks baseline, following with 12 weeks treatment phase. Subjects migraine are recorded by diary cards and re-evaluated by the investigator.
Subject will have visit every 4-week (+/- 7 days).
- Conditions
- Migraine With Aura, Migraine Without Aura
- Being tested
- Laxymig ER (drug)
- Keywords
- Migraine, Migraine prophylaxis
- Medical subject headings
- Migraine with Aura, Migraine without Aura, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laxymig ER (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in the frequency of migraine attacks
Secondary outcomes (6)
change from baseline in 4-week in migraine periods of week 9 to 12;
change from baseline in 4-week in migraine days of week 9 to 12;
the proportion of subjects with a reduction of 50% or more in 4-week migraine frequencies;
the proportion of subjects with a reduction of 50% or more in 4-week migraine periods;
the proportion of subjects with a reduction of 50% or more in 4-week migraine days
the average symptomatic medications usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startNov 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lotus Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shuu-Jiun Wang, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334178
- Sponsor's protocol ID
- LAXY-P001-R-2003
- Status last verified
- Sep 2007
- First submitted
- 5 Jun 2006
- Last updated
- 10 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Parallel, Double-Blind, Placebo-Controlled Study in Evaluation the Efficacy and Safety of Laxymig® ER as Prophylactic Treatment in Patients With Migraine
- ClinicalTrials.gov ID
- NCT00334178
- Acronym / sponsor ID
- LAXY-P001-R-2003
- Conditions
- Migraine With Aura, Migraine Without Aura
- Keywords
- Migraine, Migraine prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Lotus PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 6 Jun 2006 (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.
The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with placebo in prophylactic monotherapy treatment of migraine headache.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with placebo in prophylactic monotherapy treatment of migraine headache.
Four weeks baseline, following with 12 weeks treatment phase. Subjects migraine are recorded by diary cards and re-evaluated by the investigator.
Subject will have visit every 4-week (+/- 7 days).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of migraine with or without aura (typical aura with migraine headache)
- Subjects who had an average of two or more migraine frequencies per month during the 3 months before screening
Key exclusion criteria (5 listed)
- Female subjects who are pregnant, lactating
- Chronic daily headache
- Previous treatment with three or more migraine prophylaxis medications failed
- Subjects with hepatic disease whose liver enzymes are over 2 times of upper limit of reference or significant dysfunction
- Coexisting medical, neurological, or psychiatric disorder that may hinder the study according to the investigator's judgment
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 |
|---|---|---|
| Laxymig ER (drug) | Drug | – |
Primary outcome
change from baseline in the frequency of migraine attacks
6 secondary outcomes
change from baseline in 4-week in migraine periods of week 9 to 12;
change from baseline in 4-week in migraine days of week 9 to 12;
the proportion of subjects with a reduction of 50% or more in 4-week migraine frequencies;
the proportion of subjects with a reduction of 50% or more in 4-week migraine periods;
the proportion of subjects with a reduction of 50% or more in 4-week migraine days
the average symptomatic medications usage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2007.
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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.
Shuu-Jiun Wang, MD principal investigator
Taipei Veterans General Hospital, Taiwan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laxymig ER (drug) in people with Migraine With Aura and Migraine Without Aura, run by Lotus Pharmaceutical at 7 sites in Taiwan.
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 2 inclusion and 5 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 10 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change from baseline in the frequency of migraine attacks. 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 10 Sep 2007.