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OpenTrials
Completed

NCT Number: NCT00195754

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 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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Medical Information - Abbott

North Chicago, Illinois, 60064, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Divalproex Sodium

Drug

Primary outcomes

  1. Safety outcome measure

    Time frame: 12 months

Secondary outcomes

  1. Migraine headache rate

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2004
First posted
Sep 20, 2005
Registry last updated
Jul 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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