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MigrainePhase 3NCT00195741

The Safety and Efficacy of Divalproex Sodium Extended-Release Tablets in Migraine Prophylaxis: A Study in Adolescents

A Phase 3 study testing divalproex sodium in people with Migraine, run by Abbott at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether Depakote ER is safe and effective 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
300 participants
Where
1 siteUnited States
Study dates
May 2003to 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, including the discontinuation of any prohibited medications
  • Subject is male or a non-pregnant, non-lactating female;
  • Subject is between 12 and 17 years of age, inclusive, at randomization;
  • Subject weighs between 77 lbs (i.e., 35 kg) and 220 lbs (i.e., 100 kg) inclusive;
  • Subject currently has migraine headaches diagnosed according to the International Headache Society (IHS) diagnostic criteria occurring at an average frequency of at least 3, but no more than 12, migraine headaches per month during the 3 months prior to screening. Migraine headaches separated by a headache-free interval of < 48 hours will be considered one migraine headache in assessing this criterion;
  • Subject's initial onset of migraine headache precedes the Screening Visit by at least 12 months;
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  • 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. When the Screening and Baseline Visits are combined as described in Section 5.1, continuing participation in the Baseline Phase will be contingent upon laboratory and ECG results. Any repeat laboratory testing must be completed in consultation with the Abbott Medical Monitor prior to randomization.
  • Experimental Phase
  • The following criteria define eligibility for subject enrollment in the
  • Experimental Phase and subsequent randomization and study drug assignment:
  • Subject experienced at least 3, but no more than 12, migraine headaches (separated by headache-free intervals of at least 48 hours), diagnosed according to the IHS diagnostic criteria,6 during the 4-week Baseline Phase of the study; and
  • Subject is still eligible for the study based on Baseline Phase inclusion criteria.

Who cannot join

  • History of allergic reaction or significant sensitivity to valproate or similar drugs;
  • History of noncompliance with medication or medical instructions;
  • Previously randomized in this study;
  • 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);
  • History of cluster headaches (see Appendix G, Diagnostic Criteria for Headaches), seizure disorder, or suspected history of seizure disorder;
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  • History of headaches of any type occurring on 15 or more days per month, on average, or uses medications excessively for headaches (e.g., regularly taking medication on more than 10 days per month);
  • Failed more than 2 adequate regimens of prophylactic antimigraine medications, including antiepilepsy drug(s) (e.g., gabapentin, topiramate) or 1 adequate regimen of valproate;
  • Use of any prophylactic antimigraine medication within a period equivalent to < 5 half-lives of that medication before entering the Baseline Phase;
  • Daily use of any analgesic, ergotamine preparation, or nonsteroidal anti- inflammatory agent (see Appendix J, Examples of Prohibited Medications);
  • Use of the following medication classes or any specific drug listed below:
  • anticoagulants
  • antidepressants
  • antiepileptics
  • antipsychotics
  • benzodiazepines
  • beta-adrenergic blocking agents
  • calcium channel antagonists
  • cimetidine
  • corticosteroids
  • cyproheptadine
  • erythromycin
  • ethosuximide
  • lithium salts
  • methysergide
  • phenobarbital
  • pemoline
  • rifampin
  • tolbutamide
  • or zidovudine
  • Use of valproate within 30 days prior to screening;
  • Use of aspirin and/or any aspirin-containing product (e.g., Excedrin Migraine, Pepto-Bismol, Alka Seltzer) within 5 half-lives prior to randomization or at any time during the Experimental Phase of the study;
  • Use of stimulants for Attention-Deficit Hyperactivity Disorder (ADHD) (with the exception of pemoline, Cylert) where a stable treatment regimen has not been established for a minimum of at least 2 months prior to screening or the treatment regimen that has been established is at risk of changing sometime during the trial;
  • Any serious medical or psychiatric disorder(s) 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; or
  • For any reason, subject is considered by the investigator to be an unsuitable candidate to receive Depakote or to participate in this study. Experimental Phase
  • Subjects exhibiting any of the following will be ineligible:
  • A positive pregnancy test result on Study Day 1;
  • Failure to properly maintain the Headache and Medication Diary, during the Baseline phase, to the extent that headache occurrences cannot be determined, due to noncompliance;
  • Excessive use of symptomatic medication(s) during the Baseline Phase (e.g., regularly taking medication on more than 10 days per month); or
  • Ineligibility for the study based on the Baseline Phase exclusion criteria.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Global Medical Information - Abbott

    North Chicago, Illinois, 60064

Other trials in United States

About this study

Official title: Phase III, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Center Study Designed to Evaluate the Safety and Efficacy of Prophylactic Depakote ER in the Treatment of Adolescent Migraine

The purpose of this study is to determine whether Depakote ER is safe and effective in the reduction of occurrence of migraine headaches in adolescents.

Conditions
Migraine
Being tested
divalproex sodium
Keywords
Migraine, Depakote ER
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.

  1. Reduction from baseline in 4-week migraine headache rate

Secondary outcomes (3)

  1. Migraine headache rate in last 4 weeks of study

  2. Percent reduction from baseline

  3. Percent of subjects with > 75% reduction in migraine headache rate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startMay 2003

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00195741
Sponsor's protocol ID
M02-488
Status last verified
Feb 2007
First submitted
13 Sep 2005
Last updated
8 Feb 2007
Results posted
No

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 12 inclusion and 45 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 8 Feb 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?

Reduction from baseline in 4-week migraine headache rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00195741.

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 8 Feb 2007.

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