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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR PRIMIDONE


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All Clinical Trials for Primidone

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00006025 ↗ Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma Completed National Cancer Institute (NCI) Phase 1 2001-01-05 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
NCT00006025 ↗ Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma Completed North American Brain Tumor Consortium Phase 1 2001-01-05 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
NCT00006025 ↗ Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma Completed Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Phase 1 2001-01-05 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for Primidone

Condition Name

5550-0.500.511.522.533.544.555.5Essential TremorEpilepsies, PartialSeizures[disabled in preview]
Condition Name for Primidone
Intervention Trials
Essential Tremor 5
Epilepsies, Partial 5
Seizures 5
[disabled in preview] 0
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Condition MeSH

765001234567TremorEssential TremorSeizures[disabled in preview]
Condition MeSH for Primidone
Intervention Trials
Tremor 7
Essential Tremor 6
Seizures 5
[disabled in preview] 0
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Clinical Trial Locations for Primidone

Trials by Country

+
Trials by Country for Primidone
Location Trials
United States 35
Hungary 2
Australia 1
Brazil 1
Mexico 1
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Trials by US State

+
Trials by US State for Primidone
Location Trials
North Carolina 4
Maryland 4
New York 3
Massachusetts 3
California 3
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Clinical Trial Progress for Primidone

Clinical Trial Phase

5.6%27.8%66.7%0024681012Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for Primidone
Clinical Trial Phase Trials
Phase 4 1
Phase 3 5
Phase 2 12
[disabled in preview] 0
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Clinical Trial Status

76.2%14.3%9.5%00246810121416CompletedWithdrawnUnknown status[disabled in preview]
Clinical Trial Status for Primidone
Clinical Trial Phase Trials
Completed 16
Withdrawn 3
Unknown status 2
[disabled in preview] 0
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Clinical Trial Sponsors for Primidone

Sponsor Name

trials01122334455667Johnson & Johnson Pharmaceutical Research & Development, L.L.C.National Cancer Institute (NCI)Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins[disabled in preview]
Sponsor Name for Primidone
Sponsor Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 6
National Cancer Institute (NCI) 4
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 2
[disabled in preview] 0
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Sponsor Type

50.0%38.1%11.9%0-20246810121416182022OtherIndustryNIH[disabled in preview]
Sponsor Type for Primidone
Sponsor Trials
Other 21
Industry 16
NIH 5
[disabled in preview] 0
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Primidone: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Primidone

Primidone, marketed under the brand name Mysoline, is an anticonvulsant medication widely used in the management of various types of seizures and essential tremor. This article delves into the clinical trials, market analysis, and future projections of primidone, providing a holistic view of its significance and potential.

Clinical Trials and Efficacy

Early Clinical Trials

The efficacy of primidone was first evaluated in several clinical trials in the mid-20th century. Handley and Stewart found that primidone was effective in 80% of 40 patients with grand mal seizures[1]. In another study by Butler, improvement was observed in 50% of patients with grand mal attacks out of 58 patients with various types of seizures[1]. Smith and McNaughton reported improvement in 35% of 61 patients treated with primidone[1].

Mechanism of Action and Pharmacodynamics

Primidone works by altering sodium and calcium channel transport, thereby reducing the frequency of nerve firing. This mechanism is crucial for its anticonvulsant effects and its use in managing essential tremor[4].

Market Analysis

Current Market Size and Growth

The primidone market has maintained a steady size, valued at several million dollars in 2025, and is projected to grow at a moderate Compound Annual Growth Rate (CAGR) during the forecast period of 2025-2033. The increasing prevalence of epilepsy, especially among children, and the growing awareness of its management are key drivers of this growth[2].

Market Segments and Competition

Primidone is primarily used in the treatment of epilepsy and is available in tablet and suspension forms. Key companies operating in the market include Valeant, Amneal Pharm, Anda Repository, and Hikma Intl Pharms. Geographically, North America and Europe hold significant market shares due to the high prevalence of epilepsy and well-established healthcare systems. The Asia-Pacific region is expected to emerge as a promising market driven by the increasing population and rising disposable incomes[2].

Regional Dynamics

The United States is the largest market for primidone and is expected to grow at a moderate rate in the coming years. The European market also anticipates moderate growth, while the Asia-Pacific market is projected to grow at a faster rate compared to other regions. The Middle East & Africa and South America regions are expected to show moderate growth due to developing healthcare infrastructure and growing demand for anticonvulsants[2].

Market Trends and Drivers

Increasing Prevalence of Epilepsy

The rising incidence of epilepsy, particularly among children, is a significant factor driving the growth of the primidone market. Epilepsy is a neurological disorder that causes seizures, and the need for effective anticonvulsant medications is increasingly critical[2].

Development of Advanced Delivery Systems

The development of advanced delivery systems and generic versions of primidone is another factor contributing to market growth. These advancements make the medication more accessible and affordable for a broader patient population[2].

Growing Awareness and Healthcare Infrastructure

Growing awareness of epilepsy management and improvements in healthcare infrastructure, especially in emerging markets, are also driving the demand for primidone. This includes better diagnostic capabilities and increased access to anticonvulsant medications[2].

Challenges and Restraints

Side Effects and Adverse Reactions

Primidone, while effective, can cause side effects such as drowsiness, dizziness, and nausea. These adverse reactions can impact patient compliance and overall market growth[4].

Contraindications and Black Box Warnings

Primidone has contraindications and black box warnings, particularly regarding the risk of status epilepticus with abrupt cessation of the medication. This necessitates careful patient counseling and monitoring[4].

Future Projections

Market Growth Projections

The primidone market is expected to grow steadily over the next decade, driven by the increasing prevalence of epilepsy and the demand for generic anticonvulsants. The Asia-Pacific region is anticipated to be a key growth area due to its large population and improving healthcare infrastructure[2].

Technological and Pharmaceutical Advancements

Advancements in pharmaceutical technology, including the development of more efficient delivery systems and potentially new formulations, could further enhance the market for primidone. These innovations could improve the drug's efficacy and reduce side effects, making it more appealing to both patients and healthcare providers[5].

Key Takeaways

  • Efficacy in Clinical Trials: Primidone has shown significant efficacy in treating various types of seizures and essential tremor in early clinical trials.
  • Market Growth: The primidone market is projected to grow at a moderate CAGR from 2025 to 2033, driven by the increasing prevalence of epilepsy and advancements in delivery systems.
  • Regional Dynamics: North America and Europe are significant markets, while the Asia-Pacific region is expected to show rapid growth.
  • Challenges: Side effects and contraindications are key challenges that need to be addressed.
  • Future Projections: The market is expected to benefit from technological advancements and growing awareness of epilepsy management.

FAQs

What is primidone used for?

Primidone is used to treat grand mal, psychomotor, and focal epileptic seizures, as well as essential tremor[4].

What are the common side effects of primidone?

Common side effects include drowsiness, dizziness, and nausea[4].

Which regions are expected to drive the growth of the primidone market?

North America, Europe, and particularly the Asia-Pacific region are expected to drive market growth[2].

What are the key drivers of the primidone market?

The increasing prevalence of epilepsy, growing awareness of its management, and advancements in delivery systems are key drivers[2].

Can primidone be used in children?

Yes, primidone can be used in children, and the increasing prevalence of epilepsy among children is a significant factor driving market growth[2].

Sources

  1. Handley and Stewart, "CLINICAL EVALUATION OF PRIMIDONE (MYSOLINE), NEW ANTICONVULSANT DRUG," JAMA.
  2. Data Insights Market, "Primidone Market Predictions and Opportunities 2025-2033."
  3. Otsuka Pharmaceutical Development & Commercialization, Inc., "2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole."
  4. DrugBank Online, "Primidone: Uses, Interactions, Mechanism of Action."
  5. Cognitive Market Research, "Primidone Market Report 2024 (Global Edition)."

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