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.

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195754

Enrollment

114

Registered

2005-09-20

Start date

2004-07-31

Completion date

Unknown

Last updated

2007-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraines

Keywords

Migraines, Depakote ER, divalproex sodium

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.

Interventions

DRUGdivalproex sodium

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Safety outcome measure	12 months

Secondary

Measure	Time frame
Migraine headache rate	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026