Migraine DisordersNCT00297336
An Observational Study Evaluating the Safety of Topiramate for the Prevention of Migraine
An observational study of Migraine Disorders, run by Janssen Cilag Pharmaceutica S.A.C.I., Greece.
Trial summary
A 6-month, observational, post authorization safety study for the collection and evaluation of additional safety data on topiramate as a prophylactic treatment for migraines in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Topiramate
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Feb 2007
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study a total number of 80 patients with diagnosed migraine according to the criteria of the International Headache Society HIS (Cephalalgia 1998; 8 (Suppl7) :1-98) will participate. Patients who will be enrolled should be either male or female over 18 years of age, they should satisfy the migraine prophylactic medication criteria, and will agree to sign the written informed consent for the anonymous and confidential use of their medical data with their participation in the study.
Who may be able to join
- Patients who meet the IHS (International Headache Society) diagnostic criteria for migraine
- Patients who satisfy the migraine prophylactic medication criteria
Who cannot join
- Ineligible patient according to the marketed Summary of Product Characteristics of topiramate
- Patient with hypersensitivity to topiramate or to some of its components
About this study
Official title: An Open-label Observational Safety Study During Administration of Topiramate, for the Prophylaxis of Migraine
A 6-month, observational, post authorization safety study for the collection and evaluation of additional safety data on topiramate as a prophylactic treatment for migraines in adult patients. According to current European and international guidelines the safety and efficacy of drugs will be continuously monitored even after their approval and market circulation.The applicable methods of monitoring include: Observational studies, voluntarily reported adverse events, clinical trials of IV phase and Post Authorization Safety Studies ( PASS). Post Authorization Safety Studies (PASS) during the use of a product are a significant source of information regarding the action of the drug or a therapeutic method under the circumstances of every day clinical practice.
Read the detailed description
Previous studies have shown that topiramate is effective in preventing migraine headaches. This is a 6-month observational study to evaluate additional safety data of topiramate in the prevention of migraine in adult patients. The study duration is 6-months, with 5 study visits during the study. Administration of topiramate should be according to current Summary of Product Characteristics (SmPC) and daily clinical practice. The decision to prescribe topiramate is decided by the Health Care Professional and it is independent of the protocol. Based on the investigator's judgement, patients who enter the study should fulfill the criteria for administration of prophylactic treatment. In this study a total number of 80 patients with diagnosed migraine according to the criteria of the International Headache Society HIS (Cephalalgia 1998; 8 (Suppl7) :1-98) will participate. Patients who will be enrolled should be either male or female over 18 years of age, fulfilling the above mentioned criteria and who will agree to sign the written informed consent for the anonymous and confidential use of their medical data with their participation in the study. Methods of evaluation include tolerability, laboratory tests, vital signs and Body Weight and Body Mass Index (BMI). Efficacy by assessing migraine attacks, symptomatic medications and Headache Impact Test (HIT-6). Observational study - No investigational drug administered.
- Conditions
- Migraine Disorders
- Being tested
- Topiramate
- Keywords
- Topiramate, Migraine, Headache, Chronic headache, Chronic migraine
- Medical subject headings
- Migraine Disorders, Headache, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
80 patients with diagnosed with migraine
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is effectiveness of topiramate based on the frequency of migraine headaches during the monotherapy with topiramate.
Measured: Visit 1 and visit 5
Secondary outcomes (1)
Safety of topiramate (number of SAEs, AEs, Laboratory findings)
Measured: Visits: 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startMar 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., Greece
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial, Study director, Janssen-Cilag Pharmaceutica S.A.C.I.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297336
- Sponsor's protocol ID
- CR002116
- Status last verified
- Apr 2010
- First submitted
- 24 Feb 2006
- Last updated
- 27 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Observational Safety Study During Administration of Topiramate, for the Prophylaxis of Migraine
- ClinicalTrials.gov ID
- NCT00297336
- Acronym / sponsor ID
- CR002116
- Conditions
- Migraine Disorders
- Keywords
- Topiramate, Migraine, Headache, Chronic headache, Chronic migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., GreeceIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 28 Feb 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.
A 6-month, observational, post authorization safety study for the collection and evaluation of additional safety data on topiramate as a prophylactic treatment for migraines in adult patients. According to current European and international guidelines the safety and efficacy of drugs will be continuously monitored even after their approval and market circulation.The applicable methods of monitoring include: Observational studies, voluntarily reported adverse events, clinical trials of IV phase and Post Authorization Safety Studies ( PASS). Post Authorization Safety Studies (PASS) during the use of a product are a significant source of information regarding the action of the drug or a therapeutic method under the circumstances of every day clinical practice.
Detailed description
Previous studies have shown that topiramate is effective in preventing migraine headaches. This is a 6-month observational study to evaluate additional safety data of topiramate in the prevention of migraine in adult patients. The study duration is 6-months, with 5 study visits during the study. Administration of topiramate should be according to current Summary of Product Characteristics (SmPC) and daily clinical practice. The decision to prescribe topiramate is decided by the Health Care Professional and it is independent of the protocol. Based on the investigator's judgement, patients who enter the study should fulfill the criteria for administration of prophylactic treatment. In this study a total number of 80 patients with diagnosed migraine according to the criteria of the International Headache Society HIS (Cephalalgia 1998; 8 (Suppl7) :1-98) will participate. Patients who will be enrolled should be either male or female over 18 years of age, fulfilling the above mentioned criteria and who will agree to sign the written informed consent for the anonymous and confidential use of their medical data with their participation in the study. Methods of evaluation include tolerability, laboratory tests, vital signs and Body Weight and Body Mass Index (BMI). Efficacy by assessing migraine attacks, symptomatic medications and Headache Impact Test (HIT-6). Observational study - No investigational drug administered.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: Topiramate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study a total number of 80 patients with diagnosed migraine according to the criteria of the International Headache Society HIS (Cephalalgia 1998; 8 (Suppl7) :1-98) will participate. Patients who will be enrolled should be either male or female over 18 years of age, they should satisfy the migraine prophylactic medication criteria, and will agree to sign the written informed consent for the anonymous and confidential use of their medical data with their participation in the study.
Key inclusion criteria (2 listed)
- Patients who meet the IHS (International Headache Society) diagnostic criteria for migraine
- Patients who satisfy the migraine prophylactic medication criteria
Key exclusion criteria (2 listed)
- Ineligible patient according to the marketed Summary of Product Characteristics of topiramate
- Patient with hypersensitivity to topiramate or to some of its components
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 |
|---|---|---|
| Topiramate80 patients with diagnosed with migraine | Drug | 001 |
Primary outcome
The primary outcome is effectiveness of topiramate based on the frequency of migraine headaches during the monotherapy with topiramate.
Time frame: Visit 1 and visit 5
1 secondary outcome
Safety of topiramate (number of SAEs, AEs, Laboratory findings)
Time frame: Visits: 1-5
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 27 Apr 2010.
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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.
Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial study director
Janssen-Cilag Pharmaceutica S.A.C.I.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by Janssen Cilag Pharmaceutica S.A.C.I., Greece.
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 2 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 27 Apr 2010. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The primary outcome is effectiveness of topiramate based on the frequency of migraine headaches during the monotherapy with topiramate. (time frame: Visit 1 and visit 5). 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 27 Apr 2010.