MigrainePhase 3NCT00195806
Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine
A Phase 3 study testing divalproex sodium in people with Migraine, 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
- Migraine
- What is being tested?
- divalproex sodium
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to 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;
- Subject is male, or a non-pregnant, non-lactating female;
- Subject is between 12 and 17 years of age, inclusive, at the Screening Visit;
- Subject weighs at least 77 lbs. (i.e., 35 kg);
- Subject currently has diagnosis of migraine headaches consistent with International Headache Society (IHS) criteria;
- Subject is judged to be in generally good health based on the results of a medical history, physical examination, 12-lead electrocardiogram (ECG), and laboratory profile; and
- In the investigator's opinion, the subject will benefit from Depakote ER for migraine prophylaxis.
Who cannot join
- History of allergic reaction or significant sensitivity to valproate or similar drugs;
- History of noncompliance with medication or medical instructions;
- Recent (previous 6 months) history of drug and/or alcohol abuse or has a positive urine drug screen, at the Screening Visit, for drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and phencyclidine [PCP]);
- Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives) as judged by the investigator.
- Use of the following medication classes or any specific drug listed below:
- anti-depressants, other antiepileptic drugs (AEDs)
Show all 18Show fewer
- aspirin and/or aspirin-containing products
- chronic use of systemic corticosteroids, clonazepam,diazepam, erythromycin, ethosuximide, pemoline, phenobarbital,rifampin,tolbutamide, zidovudine
- anticoagulant drug therapy;
- Any serious medical or psychiatric disorder(s), including epilepsy and obesity, that may confound the interpretation of the results from this study;
- Central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease;
- History of encephalopathy, hepatitis, pancreatitis, or urea-cycle disorder or any underlying condition/disease, which might interfere with study drug absorption or completion of study drug therapy evaluation throughout the duration of the trial;
- Screening laboratory results indicate the presence of Hepatitis B surface antigen (HBsAg), or Hepatitis C antibody or known history of any positive test result for HIV;
- Screening laboratory results indicate:
- Platelet count =/< 100,000/uL
- ALT or AST =/> 2 times Upper Limit of Normal (ULN);
- Receipt of an investigational drug within 30 days prior to study drug administration or scheduled to receive any other investigational drug anytime during the study;
- Participation in a prior Depakote ER migraine study (M02-488 or M02-554); or if for any reason, subject is considered by the investigator to be an unsuitable candidate to receive Depakote 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: Divalproex Sodium Extended-Release Tablets for Migraine Prophylaxis in Adolescents: An Open-Label, Long-Term Safety Study
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
- Migraine
- Being tested
- divalproex sodium
- Keywords
- Migraine, 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.
Number of migraine headache days
Secondary outcomes (5)
Adverse events
Laboratory data
Vital signs
Study drug exposure
Behavioral/cognitive assessments
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 startFeb 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 315 participants
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
- NCT00195806
- Sponsor's protocol ID
- M03-648
- Status last verified
- Aug 2007
- First submitted
- 14 Sep 2005
- Last updated
- 3 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Divalproex Sodium Extended-Release Tablets for Migraine Prophylaxis in Adolescents: An Open-Label, Long-Term Safety Study
- ClinicalTrials.gov ID
- NCT00195806
- Acronym / sponsor ID
- M03-648
- Conditions
- Migraine
- Keywords
- Migraine, Depakote ER, Divalproex sodium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- 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 (7 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;
- Subject is male, or a non-pregnant, non-lactating female;
- Subject is between 12 and 17 years of age, inclusive, at the Screening Visit;
- Subject weighs at least 77 lbs. (i.e., 35 kg);
- Subject currently has diagnosis of migraine headaches consistent with International Headache Society (IHS) criteria;
Key exclusion criteria (18 listed)
- History of allergic reaction or significant sensitivity to valproate or similar drugs;
- History of noncompliance with medication or medical instructions;
- Recent (previous 6 months) history of drug and/or alcohol abuse or has a positive urine drug screen, at the Screening Visit, for drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and phencyclidine [PCP]);
- Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives) as judged by the investigator.
- Use of the following medication classes or any specific drug listed below:
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
Number of migraine headache days
5 secondary outcomes
Adverse events
Laboratory data
Vital signs
Study drug exposure
Behavioral/cognitive assessments
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 3 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.
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 Migraine, 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 7 inclusion and 18 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 3 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 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?
Number of migraine headache days. 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 3 Sep 2007.