NCT00195754A 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
NCT00195767Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and AdolescentsBipolar I Disorder, Manic or Mixed
NCT00067262An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and AdolescentsBipolar Disorder
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.
Reduction from baseline in 4-week migraine headache rate
Change from baseline to the final evaluation in Y-MRS score.
mood and anxiety symptoms over time [SCL-90-R (Symptom Check List)].
The psychiatric rating scale battery will include the PANSS, the CGI Scale, and the CDSS. The NOSIE, Overall Treatment Evaluation, Burden Questionnaire, and Quality of Life Scale.
Inclusion Criteria:
Subject has diagnosis of partial seizures with/without secondary generalization, supported by:
* Observed ictal events consistent with partial seizures with/without secondary generalization; Documented by reliable observers
* 1 of following 3:
* EEG at some time in past demo...
Divalproex is used for partial seizures, bipolar I disorder including manic or mixed episodes, and migraine prophylaxis. It is being studied in pediatric and adolescent populations for these conditions. The drug is in Phase 3 clinical development and is not yet approved for these uses.
Who makes Divalproex?
Divalproex is being developed by Abbott Laboratories, traded on the New York Stock Exchange under the ticker ABT. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in treating partial seizures, bipolar disorder, and migraines in children and adolescents.
What phase is Divalproex in?
Divalproex is in Phase 3 clinical development. All four clinical trials listed for the drug are Phase 3 studies and have been completed. The drug remains investigational and has not received FDA approval for the indications being studied.
What clinical trials is Divalproex in?
Divalproex has completed four Phase 3 trials, including NCT00102713 for partial seizures in children, NCT00195741 for migraine prophylaxis in adolescents, NCT00195767 for mania associated with bipolar disorder in children and adolescents, and NCT00195806 for migraine prophylaxis in adolescents. All trials were conducted in the United States.
Is Divalproex the same as Depakote?
Yes, Divalproex is the same as Depakote. Clinical trial NCT00195767 refers to Depakote Extended Release Tablets, and NCT00195806 refers to Depakote ER, both of which are formulations of Divalproex. The drug is being studied for bipolar disorder and migraine in these trials.