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.

NCT00195754 | Completed Phase 3

• 1 other identifier: M02-554
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraines

Keywords

Migraines; Depakote ER; divalproex sodium

Outcome Measures

Primary Outcomes (1)

• Safety outcome measure

  12 months

Secondary Outcomes (1)

• Migraine headache rate

  12 months

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;
• 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

You may not qualify if:

• 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.

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2004
• Last Updated: July 31, 2007

Record last verified: 2007-07

Locations

US (1)