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.

Migraines Clinical Trial

Official title:

The Safety of Divalproex Sodium Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Study in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195754
• Other study ID #: M02-554
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: July 30, 2007
• Start date: July 2004

Study information

• Verified date: July 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Migraines

Intervention

Drug:
• divalproex sodium

Locations

Country	Name	City	State
United States	Global Medical Information - Abbott	North Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety outcome measure		12 months
Secondary	Migraine headache rate		12 months