Recent Updates
Recently added Catalysts

Divalproex

Phase 4FDA approved

Bipolar Disorder | Small molecule | Psychiatry |Abbott Laboratories|Trials Updated: Oct 8, 2009

Divalproex development status

FDA approval on record Aug 4, 2000
Approval holderAbbvie
ApplicationNDA021168
Highest phase Phase 4 run by Eli Lilly and Company (NCT00402324)
Phase scored for ABTPhase 3
Registered trials 4 across 3 sponsors since Apr 2005

Label indication Depakote ER is indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features ( 1.1 ) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; FDA label

Divalproex target and mechanism

Molecular targetALDH5A1
Target classInhibitor
ModalitySmall molecule

Also known as Divalproex Sodium Extended-Release Tablets, divalproex sodium extended release

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials10
Total Enrollment2,116

FDA Designations

No designations recorded

Divalproex clinical trials

Divalproex · 10 trials · 10 indications

Phase 3 8Phase 2 2
NCT00102713A Study for Treatment of Partial Seizures in ChildrenPartial Seizures
COMPLETED50 Analytics
NCT00195780A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and AdolescentsBipolar I Disorder
COMPLETED227 Analytics
NCT00195806Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With MigraineMigraine
COMPLETED315 Analytics
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
COMPLETED114 Analytics
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
COMPLETED150 Analytics
NCT00195741The Safety and Efficacy of Divalproex Sodium Extended-Release Tablets in Migraine Prophylaxis: A Study in AdolescentsMigraine
COMPLETED300 Analytics
NCT00067262An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and AdolescentsBipolar Disorder
COMPLETED150 Analytics
NCT00060905An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar DisorderBipolar Disorder
COMPLETED370 Analytics
PHASE3COMPLETED
A Study for Treatment of Partial Seizures in Children
Partial SeizuresUnlock trial analytics
PHASE3COMPLETED
A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
Bipolar I DisorderUnlock trial analytics
PHASE3COMPLETED
Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine
MigraineUnlock trial analytics
PHASE3COMPLETED
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.
MigrainesUnlock trial analytics
PHASE3COMPLETED
Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents
Bipolar I Disorder, Manic or MixedUnlock trial analytics
PHASE3COMPLETED
The Safety and Efficacy of Divalproex Sodium Extended-Release Tablets in Migraine Prophylaxis: A Study in Adolescents
MigraineUnlock trial analytics
PHASE3COMPLETED
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
Bipolar DisorderUnlock trial analytics
PHASE3COMPLETED
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
Bipolar DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Partial Seizure Rate at Week 4
Safety
Number of migraine headache days
Safety outcome measure
12 months
Safety outcome measures
Reduction from baseline in 4-week migraine headache rate
Change from baseline to the final evaluation in Y-MRS score.
Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
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.

Secondary Endpoints

Adverse Events
WASI
WPPSI-III
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Divalproex Sodium (Depakote Sprinkle Capsules)DRUG -
Divalproex Sodium (Depakote ER)DRUG -
divalproex sodiumDRUG -
Divalproex Sodium Extended-Release TabletsDRUG -
divalproex sodium extended releaseDRUG -
OlanzapineDRUG -
RisperidoneDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range3 Years to 10 Years
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Divalproex

What is divalproex?

Divalproex is a small molecule drug developed by Abbott Laboratories, which trades under the ticker ABT. It is being studied in Phase 2 clinical trials for alcoholism, bipolar disorder, and schizophrenia. Divalproex is also known as divalproex sodium extended-release tablets. It is an investigational therapy in these psychiatric indications.

What does divalproex target?

Divalproex targets ALDH5A1, also known as succinate-semialdehyde dehydrogenase. It acts as an inhibitor of this enzyme. This molecular target is involved in the metabolism of gamma-aminobutyric acid (GABA). By inhibiting ALDH5A1, divalproex may modulate GABAergic signaling, which is relevant to its studied psychiatric indications.

Who makes divalproex?

Divalproex is developed by Abbott Laboratories, a pharmaceutical company that trades on the New York Stock Exchange under the ticker symbol ABT. Abbott Laboratories is responsible for the clinical development of divalproex in the studied indications of alcoholism, bipolar disorder, and schizophrenia.

What phase is divalproex in?

Divalproex is in Phase 2 clinical development. It has been tested in completed Phase 2 and Phase 3 trials for psychiatric conditions. The drug is investigational and has not been approved by the FDA for the studied indications. Abbott Laboratories is the developer.

What clinical trials is divalproex in?

Divalproex has been studied in completed clinical trials including NCT00202514, a Phase 2 placebo-controlled trial in alcohol-dependent patients with mood or anxiety symptoms; NCT00073164, a Phase 2 trial in schizophrenia; and NCT00067262, a Phase 3 trial in pediatric bipolar disorder. All trials were conducted in the United States.

Is divalproex the same as divalproex sodium extended-release tablets?

Yes, divalproex is also known as divalproex sodium extended-release tablets, or divalproex sodium extended release. These names refer to the same medication developed by Abbott Laboratories. The extended-release formulation has been used in clinical trials for alcoholism, bipolar disorder, and schizophrenia.