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Valproic acid

Generic Name
Valproic acid
Brand Names
Depakene, Depakote, Epival
Drug Type
Small Molecule
Chemical Formula
C8H16O2
CAS Number
99-66-1
Unique Ingredient Identifier
614OI1Z5WI
Background

Valproic acid, or valproate, is an fatty acid derivative and anticonvulsant originally synthesized in 1881 by Beverly S. Burton. It enjoyed use as a popular organic solvent in industry and pharmaceutical manufacturing for nearly a century. In 1963, a serendipitous discovery was made by George Carraz during his investigations into the anticonvulsant effects of khelline when he found that all of his samples, dissolved in valproic acid, exerted a similar degree of anticonvulsive activity. It first received approval on February 28, 1978 from the FDA under the trade name Depakene.

Since then, it has been investigated for neuroprotective, anti-manic, and anti-migraine effects. It is currently a compound of interest in the field of oncology for its anti-proliferative effects and is the subject of many clinical trials in a variety of cancer types.

Indication

Indicated for:

1) Use as monotherapy or adjunctive therapy in the management of complex partial seizures and simple or complex absence seizures.

2) Adjunctive therapy in the management of multiple seizure types that include absence seizures.

3) Prophylaxis of migraine headaches.

4) Acute management of mania associated with bipolar disorder.

Off-label uses include:

1) Maintenance therapy for bipolar disorder.

2) Treatment for acute bipolar depression.

3) Emergency treatment of status epilepticus.

Associated Conditions
Bipolar Disorder (BD), Complex Partial Seizure Disorder, Depressive Episodes, Migraine, Petit Mal Epilepsy, Seizure, multiple types, Acute Manic episode
Associated Therapies
-

Temsirolimus and Valproic Acid in Treating Young Patients With Relapsed Neuroblastoma, Bone Sarcoma, or Soft Tissue Sarcoma

Phase 1
Terminated
Conditions
Brain and Central Nervous System Tumors
Neuroblastoma
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
First Posted Date
2010-09-17
Last Posted Date
2016-12-23
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Target Recruit Count
7
Registration Number
NCT01204450
Locations
🇺🇸

Carolina Healthcare System, Charlotte, North Carolina, United States

🇺🇸

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer

Phase 1
Conditions
Locally Advanced Inoperable Non-small-lung Cancer
Interventions
First Posted Date
2010-09-16
Last Posted Date
2011-03-29
Lead Sponsor
Soroka University Medical Center
Target Recruit Count
20
Registration Number
NCT01203735
Locations
🇮🇱

Soroka University Medical Center, Beer Sheva, Israel

Add-on Dextromethorphan in Bipolar Disorders

Phase 3
Completed
Conditions
Bipolar Disorder
Interventions
First Posted Date
2010-08-25
Last Posted Date
2013-09-17
Lead Sponsor
National Cheng-Kung University Hospital
Target Recruit Count
300
Registration Number
NCT01188265
Locations
🇨🇳

Ru-Band Lu, Tainan, Taiwan

A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Cell Origin

Phase 2
Completed
Conditions
Thyroid Neoplasm
Interventions
First Posted Date
2010-08-16
Last Posted Date
2018-05-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
13
Registration Number
NCT01182285
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Seizures Post Intracerebral Hemorrhage

Phase 4
Completed
Conditions
Post Cerebral Hemorrhage
Interventions
Drug: valproic acid
Drug: placebo bid
First Posted Date
2010-05-04
Last Posted Date
2014-06-12
Lead Sponsor
Wolfson Medical Center
Target Recruit Count
72
Registration Number
NCT01115959

Safety Study of Depakote Versus Lithium in African Americans With Bipolar Disorder

Phase 4
Withdrawn
Conditions
Bipolar Disorder
First Posted Date
2010-02-24
Last Posted Date
2010-02-24
Lead Sponsor
Lawson, William B., M.D., PhD, DFAPA
Target Recruit Count
50
Registration Number
NCT01075126
Locations
🇺🇸

Howard University Hospital, Washington, District of Columbia, United States

A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy

Completed
Conditions
Seizures
Convulsions
Epilepsy
Osteopenia
Osteoporosis
Interventions
First Posted Date
2009-12-11
Last Posted Date
2013-06-26
Lead Sponsor
Janssen Korea, Ltd., Korea
Target Recruit Count
140
Registration Number
NCT01030094

Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia

Phase 2
Conditions
Leukemia
Lymphoma
First Posted Date
2009-11-20
Last Posted Date
2014-01-10
Lead Sponsor
Auxilio Mutuo Cancer Center
Target Recruit Count
52
Registration Number
NCT01016990
Locations
🇵🇷

Centro de Cancer del Hospital Auxilio Mutuo, San Juan, Puerto Rico

Adjuvant Valproate for High Grade Sarcomas

Phase 1
Terminated
Conditions
High Grade Sarcoma
Interventions
First Posted Date
2009-11-10
Last Posted Date
2015-05-21
Lead Sponsor
Columbia University
Target Recruit Count
7
Registration Number
NCT01010958
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

Molecular Signature of Valproic Acid in Breast Cancer With Functional Imaging Assessment - a Pilot

Phase 1
Terminated
Conditions
Cancer
Interventions
First Posted Date
2009-11-04
Last Posted Date
2016-07-20
Lead Sponsor
University of Utah
Target Recruit Count
31
Registration Number
NCT01007695
Locations
🇺🇸

Huntsman Cancer Institute, Salt Lake City, Utah, United States

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