MigrainesPhase 3NCT00195754
A Phase III Open-Label, Multi-Center, Long-Term Extension Study of Depakote ER in Subjects Who Either Completed or Prematurely Discontinued Due to Ineffectiveness From Study M02-488.
A Phase 3 study testing divalproex sodium in people with Migraines, run by Abbott at 1 site in United States.
Trial summary
The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Migraines
- What is being tested?
- divalproex sodium
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to not given
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed;
- The subject was randomized into Study M02-488 and either completed the study or prematurely discontinued due to ineffectiveness; and
- The subject is male or non-pregnant, non-lactating female
Who cannot join
- Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives).
- Experienced a serious adverse event in Study M02-488 which the investigator considered "possibly" or "probably related" to study drug; or
- In the investigator's opinion, long-term treatment with Depakote ER for migraine prophylaxis is contraindicated.
- For any reason, subject is considered by the investigator to be an unsuitable candidate to receive divalproex sodium or to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Medical Information - Abbott
North Chicago, Illinois, 60064
About this study
Official title: The Safety of Divalproex Sodium Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Study in Adolescents
The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents.
- Conditions
- Migraines
- Being tested
- divalproex sodium
- Keywords
- Migraines, Depakote ER, divalproex sodium
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
divalproex sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome measure
Measured: 12 months
Secondary outcomes (1)
Migraine headache rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigrainesStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information 800-633-9110, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195754
- Sponsor's protocol ID
- M02-554
- Status last verified
- Jul 2007
- First submitted
- 13 Sep 2005
- Last updated
- 31 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Divalproex Sodium Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Study in Adolescents
- ClinicalTrials.gov ID
- NCT00195754
- Acronym / sponsor ID
- M02-554
- Conditions
- Migraines
- Keywords
- Migraines, Depakote ER, divalproex sodium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- First posted
- 20 Sep 2005 (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 determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed;
- The subject was randomized into Study M02-488 and either completed the study or prematurely discontinued due to ineffectiveness; and
- The subject is male or non-pregnant, non-lactating female
Key exclusion criteria (4 listed)
- Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives).
- Experienced a serious adverse event in Study M02-488 which the investigator considered "possibly" or "probably related" to study drug; or
- In the investigator's opinion, long-term treatment with Depakote ER for migraine prophylaxis is contraindicated.
- For any reason, subject is considered by the investigator to be an unsuitable candidate to receive divalproex sodium or to participate in this 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 |
|---|---|---|
| divalproex sodium | Drug | – |
Primary outcome
Safety outcome measure
Time frame: 12 months
1 secondary outcome
Migraine headache rate
Time frame: 12 months
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 31 Jul 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.
Global Medical Information 800-633-9110 study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing divalproex sodium in people with Migraines, run by Abbott at 1 site in United States.
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 4 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 31 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Safety outcome measure (time frame: 12 months). 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 31 Jul 2007; AzTrials last refreshed its copy on 29 Oct 2026.