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

NCT00195741 | Completed Phase 3

• 1 other identifier: M02-488
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Keywords

Migraine; Depakote ER

Outcome Measures

Primary Outcomes (1)

• Reduction from baseline in 4-week migraine headache rate

Secondary Outcomes (3)

• Migraine headache rate in last 4 weeks of study

• Percent reduction from baseline

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

Interventions

divalproex sodium DRUG

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Global Medical Information - Abbott

North Chicago, Illinois, 60064, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Global Medical Information 800-633-9110

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2003
• Last Updated: February 8, 2007

Record last verified: 2007-02

Locations

US (1)