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Last Updated: February 9, 2025

CLINICAL TRIALS PROFILE FOR DEPACON


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All Clinical Trials for Depacon

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000439 ↗ Drug Treatment for Alcoholics With Bipolar Disorder Completed University of Pittsburgh Phase 2 2000-10-01 The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00000439 ↗ Drug Treatment for Alcoholics With Bipolar Disorder Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 2000-10-01 The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00203242 ↗ An Open Label Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches. Completed Abbott N/A 2003-07-01 The purpose of this study is to collect and evaluate information on the use of Depakote Extended Release (ER) and Depacon Intravenous (IV) in patients with cluster headaches. Patients who are currently in a cluster cycle will be treated with 2 consecutive days of IV Depacon followed by oral Depakote ER. Patients will receive a total of 1,000mg of Depacon and 1,000mg of Depakote ER each day. Patients may have a 3rd day of IV Depacon followed by oral Depakote ER if the primary investigator believes it to be beneficial. The patient is then sent home on oral Depakote ER. The dose of Depakote ER can range from 500mg to 2,000mg this dose is to be determined by the primary investigator. The patient will continue the oral Depakote ER until the end of their cluster cycle or for a maximum of 6 weeks, which ever comes first.
NCT00203242 ↗ An Open Label Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches. Completed Thomas Jefferson University N/A 2003-07-01 The purpose of this study is to collect and evaluate information on the use of Depakote Extended Release (ER) and Depacon Intravenous (IV) in patients with cluster headaches. Patients who are currently in a cluster cycle will be treated with 2 consecutive days of IV Depacon followed by oral Depakote ER. Patients will receive a total of 1,000mg of Depacon and 1,000mg of Depakote ER each day. Patients may have a 3rd day of IV Depacon followed by oral Depakote ER if the primary investigator believes it to be beneficial. The patient is then sent home on oral Depakote ER. The dose of Depakote ER can range from 500mg to 2,000mg this dose is to be determined by the primary investigator. The patient will continue the oral Depakote ER until the end of their cluster cycle or for a maximum of 6 weeks, which ever comes first.
NCT00609245 ↗ Effect of Valproic Acid Concentration on Photic Response Completed Abbott Phase 4 2007-12-01 We are trying to learn if small changes in the amount of a valproate in the blood (given through an IV) will change the way the brain reacts to flashing lights.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Depacon

Condition Name

Condition Name for Depacon
Intervention Trials
Shock,Hemorrhagic 2
Head and Neck Squamous Cell Carcinoma 1
Photosensitive Epilepsy 1
Trauma 1
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Condition MeSH

Condition MeSH for Depacon
Intervention Trials
Epilepsy 2
Shock, Hemorrhagic 2
Squamous Cell Carcinoma of Head and Neck 1
Headache 1
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Clinical Trial Locations for Depacon

Trials by Country

Trials by Country for Depacon
Location Trials
United States 7
Australia 1
Brazil 1
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Trials by US State

Trials by US State for Depacon
Location Trials
Michigan 2
Pennsylvania 2
Massachusetts 1
Tennessee 1
Missouri 1
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Clinical Trial Progress for Depacon

Clinical Trial Phase

Clinical Trial Phase for Depacon
Clinical Trial Phase Trials
Phase 4 1
Phase 2 1
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Depacon
Clinical Trial Phase Trials
Completed 6
Terminated 1
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Clinical Trial Sponsors for Depacon

Sponsor Name

Sponsor Name for Depacon
Sponsor Trials
Dr. Hasan Alam 2
Abbott 2
Vanderbilt University Medical Center 1
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Sponsor Type

Sponsor Type for Depacon
Sponsor Trials
Other 7
Industry 3
NIH 1
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Depacon (Valproate Sodium): Clinical Trials, Market Analysis, and Projections

Introduction

Depacon, also known as valproate sodium, is an injectable antiepileptic medication used to manage various types of seizure disorders. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Trials in Epilepsy

Depacon has been extensively studied in clinical trials for its efficacy in treating epilepsy. While it has not been specifically tested in controlled clinical trials for Dravet syndrome, it has been investigated as a treatment for various seizure types. A systematic review published in the journal CNS Drugs analyzed 30 studies involving 860 patients and concluded that injectable valproate is safe and effective for epilepsy treatment, particularly in children[1][2].

Safety and Tolerability

In a clinical safety trial, 112 patients with epilepsy were given infusions of Depacon over 5 to 10 minutes. The results showed that the treatment was generally well-tolerated, with common adverse reactions including somnolence, dizziness, paresthesia, asthenia, nausea, and headache. The study indicated that rapid infusions were tolerated well by the patients[2][4].

Specific Studies

A study published in Pediatric Neurology investigated the safety of rapidly infused Depacon in 18 children with epilepsy, ages 1 to 16. The study reported no serious adverse events, highlighting the safety profile of Depacon in pediatric patients[1].

Market Analysis

Current Market Position

Depacon is marketed by AbbVie and is available in generic form. It is used as an intravenous alternative when oral administration of valproate products is not feasible. The drug is indicated for monotherapy and adjunctive therapy in complex partial seizures, simple and complex absence seizures, and multiple seizure types that include absence seizures[2][4].

Market Trends

The pharmaceutical market is expected to see significant growth in 2025, driven by advancements in various therapeutic areas. However, Depacon, being an established drug, may not be at the forefront of these new trends. The focus in 2025 is expected to be on novel drug approvals and growth in areas such as obesity, oncology, and immunology, rather than on established antiepileptic drugs like Depacon[5].

Projections for Depacon

Market Stability

Given its established position and lack of recent breakthroughs or new indications, Depacon is likely to maintain a stable market presence. It will continue to be a reliable option for patients who require intravenous antiepileptic therapy, especially in scenarios where oral administration is not feasible[2][4].

Competition and Generic Availability

The availability of generic versions of Depacon could impact its market share. However, its specific use case as an intravenous alternative ensures it will remain a necessary option in clinical settings, even with generic competition[2].

Regulatory Considerations

Depacon is contraindicated in patients with hepatic disease or significant hepatic dysfunction and in those with known mitochondrial disorders caused by mutations in mitochondrial DNA. These contraindications will continue to influence its prescribing patterns and market position[4].

Side Effects and Safety Concerns

Common Adverse Reactions

Common side effects associated with Depacon include infections, abdominal pain, nausea, vomiting, diarrhea, dizziness, flu-like symptoms, hair loss, low platelet count, drowsiness, tremors, weakness, and anorexia. It is also associated with an increased risk of liver damage in children younger than 2 years old[1][2].

Hepatic Risks

The risk of fatal hepatic dysfunction is a significant concern with Depacon, particularly in children. This risk necessitates careful monitoring and limits its use in certain patient populations[2][4].

Dosage and Administration

Intravenous Use

Depacon is intended for intravenous use only, with initial doses ranging from 10 to 15 mg/kg/day, increasing at 1-week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response. The maximum recommended dose is 60 mg/kg/day[3][4].

Infusion Rates

The drug should be administered as a 60-minute infusion, with a maximum rate of 20 mg/min. Rapid infusions have been studied, but the standard infusion rate is recommended to minimize adverse reactions[4].

Key Takeaways

  • Depacon is a well-tolerated and effective intravenous antiepileptic medication.
  • It is indicated for various seizure types, including complex partial seizures and absence seizures.
  • The drug has a stable market position but may face competition from generic versions.
  • Significant side effects and safety concerns, such as hepatic risks, need careful monitoring.
  • Depacon's use is expected to remain steady, driven by its necessity in clinical settings where oral administration is not feasible.

FAQs

What is Depacon used for?

Depacon is used as an intravenous alternative for treating complex partial seizures, simple and complex absence seizures, and multiple seizure types that include absence seizures.

What are the common side effects of Depacon?

Common side effects include infections, abdominal pain, nausea, vomiting, diarrhea, dizziness, flu-like symptoms, hair loss, low platelet count, drowsiness, tremors, weakness, and anorexia.

Can Depacon be used in children?

Yes, but with caution. Depacon is associated with an increased risk of liver damage in children younger than 2 years old.

How is Depacon administered?

Depacon is administered intravenously, with initial doses ranging from 10 to 15 mg/kg/day, increasing at 1-week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response.

What are the contraindications for Depacon?

Depacon is contraindicated in patients with hepatic disease or significant hepatic dysfunction and in those with known mitochondrial disorders caused by mutations in mitochondrial DNA.

Sources

  1. Dravet Syndrome News: Depacon (Sodium Valproate) - Dravet Syndrome News.
  2. RxList: Depacon (Valproic Acid): Side Effects, Uses, Dosage, Interactions.
  3. FDA: Depacon (valproate sodium), for intravenous injection.
  4. FDA: Depacon (valproate sodium), for intravenous injection (2020 label).
  5. Pharmaceutical Manufacturer: Evaluate Releases 2025 preview for pharma market.

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