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.

Abbott

Status and phase

Completed

Phase 3

Conditions

Migraines

Treatments

Drug: divalproex sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00195754

M02-554

Details and patient eligibility

About

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.

Enrollment

114 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.