CLINICAL TRIALS PROFILE FOR DANTROLENE SODIUM

All Clinical Trials for dantrolene sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02829268 ↗	A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome	Active, not recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1/Phase 2	2017-01-01	Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions. There is a screening period up to 56 days, a 6-month treatment period with an optional extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments include medical & medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.
NCT02829268 ↗	A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome	Active, not recruiting	National Institutes of Health (NIH)	Phase 1/Phase 2	2017-01-01	Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions. There is a screening period up to 56 days, a 6-month treatment period with an optional extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments include medical & medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.
NCT02829268 ↗	A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome	Active, not recruiting	Washington University School of Medicine	Phase 1/Phase 2	2017-01-01	Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions. There is a screening period up to 56 days, a 6-month treatment period with an optional extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments include medical & medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.

Clinical Trial Conditions for dantrolene sodium

Condition Name

Condition Name for dantrolene sodium
Intervention	Trials
Diabetes Mellitus	1
Lumbar Spine Injury	1
Optic Nerve Atrophy	1

Condition MeSH

Condition MeSH for dantrolene sodium
Intervention	Trials
Optic Atrophy	1
Diabetes Mellitus	1
Atrophy	1

Clinical Trial Locations for dantrolene sodium

Trials by Country

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Trials by Country for dantrolene sodium
Location	Trials
United States	2

Trials by US State

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−

Trials by US State for dantrolene sodium
Location	Trials
Massachusetts	1
Missouri	1

Clinical Trial Progress for dantrolene sodium

Clinical Trial Phase

Clinical Trial Phase for dantrolene sodium
Clinical Trial Phase	Trials
Phase 2	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for dantrolene sodium
Clinical Trial Phase	Trials
Recruiting	1
Active, not recruiting	1

Clinical Trial Sponsors for dantrolene sodium

Sponsor Name

Sponsor Name for dantrolene sodium
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1
National Institutes of Health (NIH)	1
Washington University School of Medicine	1

Sponsor Type

Sponsor Type for dantrolene sodium
Sponsor	Trials
NIH	2
Other	2

Dantrolene Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Dantrolene sodium is a muscle relaxant medication primarily used in the management of malignant hyperthermia, neuroleptic malignant syndrome, and certain types of muscle spasticity. This article provides an update on the current clinical trials, market analysis, and projections for dantrolene sodium.

Clinical Trials Update

Safety Trial in Wolfram Syndrome

A significant clinical trial is the Phase 1b safety trial conducted by the Washington University School of Medicine to assess the safety and tolerability of dantrolene sodium in pediatric and adult patients with Wolfram syndrome. This single-center, dose-escalation study evaluates the safety of dantrolene sodium administered orally at the upper end of the therapeutic dose range for 6 months, with an optional extension phase up to 24 months[1][4].

• Primary Objective: To assess the safety and tolerability of dantrolene sodium.
• Secondary Objectives: To determine the effect of dantrolene sodium on various clinical parameters, including ophthalmic, neurologic, endocrine, and laboratory assessments.
• Methodology: The study includes baseline and confirmatory screening, a dose maximization period, and regular safety assessments at specified intervals. Liver function tests, such as ALT, AST, Alkaline Phosphatase, and bilirubin, are also monitored to check for any liver problems[1][4].

Adoption of New Formulation

In the context of malignant hyperthermia, the North American Malignant Hyperthermia Registry data indicates that the new lyophilized dantrolene sodium injectable suspension has exceeded 50% use in cases reported since its introduction. This new formulation is more concentrated, requiring less time and volume of sterile water to dissolve, thus facilitating quicker administration[3].

Market Analysis

Market Size and Growth

The dantrolene sodium market has experienced significant growth and is projected to continue this trend. As of 2023, the market size was approximately USD 1.2 billion, with expectations to reach around USD 1.9 billion by 2033, representing a Compound Annual Growth Rate (CAGR) of 4.5% from 2024 to 2033[5].

Market Segmentation

The market is segmented based on type (dantrolene sodium capsules and injectable solutions) and application (treatment and prevention of malignant hyperthermia, treatment of neuroleptic malignant syndrome, treatment of muscle spasms, and other uses). Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[2][5].

Key Drivers and Restraints

• Drivers: The increasing incidence of malignant hyperthermia, growing awareness about the importance of prompt treatment, and the recognition of the therapeutic benefits of dantrolene sodium are key drivers. Ongoing research and development to explore new therapeutic applications and improve formulations also contribute to market growth[5].
• Restraints: Challenges include the low incidence of malignant hyperthermia, potential adverse effects, and an evolving regulatory landscape[5].

Competitive Landscape

The market is characterized by the presence of both established pharmaceutical companies and generic drug manufacturers, contributing to a competitive landscape and the availability of affordable treatment options[5].

Regional Analysis

Global Footprint

The dantrolene sodium market has a global footprint with significant variations across different regions.

• North America: This region, particularly the United States, is a leading market due to its well-established healthcare infrastructure and the presence of key market players[5].
• Europe: Countries like Germany, the United Kingdom, and France play important roles in this region[5].
• Asia-Pacific: This region is expected to experience the fastest growth, driven by increasing awareness about malignant hyperthermia, expanding healthcare systems, and a growing burden of muscle-related disorders in countries like China, India, and Japan[5].
• Latin America and Middle East & Africa: These regions present opportunities for market growth, although the availability and accessibility of dantrolene sodium may be relatively lower compared to other regions[5].

Market Projections

Future Growth

The dantrolene sodium market is poised for continued growth driven by the persistent need for effective muscle relaxant therapies in managing malignant hyperthermia and other muscle-related disorders. Factors such as the development of improved formulations, exploration of new therapeutic applications, and integration of technological advancements in drug delivery systems will contribute to the market's expansion[5].

Emerging Opportunities

Emerging markets in regions like Asia-Pacific, Latin America, and the Middle East & Africa offer untapped potential as awareness about the availability and benefits of dantrolene sodium grows. The integration of technological advancements, such as novel drug delivery systems or patient-centric features, can enhance the convenience, safety, and efficacy of dantrolene sodium-based treatments[5].

"The increasing awareness about the importance of prompt treatment for malignant hyperthermia and the growing recognition of the critical role of dantrolene sodium in managing this life-threatening condition create a significant demand for this specialized medication."[5]

Key Takeaways

• Clinical Trials: Ongoing trials, such as the Phase 1b safety trial for Wolfram syndrome, are crucial for expanding the therapeutic applications of dantrolene sodium.
• Market Growth: The market is expected to grow significantly, driven by increasing incidence of malignant hyperthermia and growing awareness about the drug's benefits.
• Regional Variations: The market has a global footprint with varying growth rates and competitive dynamics across different regions.
• Technological Advancements: Integration of new technologies in drug delivery systems and patient-centric approaches will enhance market growth.

FAQs

What is the primary use of dantrolene sodium?

Dantrolene sodium is primarily used in the management of malignant hyperthermia, neuroleptic malignant syndrome, and certain types of muscle spasticity.

What is the current market size of dantrolene sodium?

As of 2023, the market size of dantrolene sodium was approximately USD 1.2 billion.

What is the projected growth rate of the dantrolene sodium market?

The market is expected to grow at a CAGR of 4.5% from 2024 to 2033, reaching around USD 1.9 billion by 2033.

Which regions are expected to drive the growth of the dantrolene sodium market?

The Asia-Pacific region is expected to experience the fastest growth, followed by North America and Europe.

What are the key drivers of the dantrolene sodium market?

Key drivers include the increasing incidence of malignant hyperthermia, growing awareness about the importance of prompt treatment, and ongoing research and development to explore new therapeutic applications.

What are the potential restraints to the dantrolene sodium market?

Challenges include the low incidence of malignant hyperthermia, potential adverse effects, and an evolving regulatory landscape.

Sources

1. A Safety Trial of Dantrolene Sodium in Pediatric and Adult Patients with Wolfram Syndrome. Washington University School of Medicine.
2. Global Dantrolene Sodium Market Size, Trends and Projections. Market Research Intellect.
3. Abstracts & Articles - Anesthesiology - University of Florida.
4. Clinical Trials - Wolfram Syndrome Research Alliance.
5. Dantrolene Sodium Market Size, Share, Growth, Statistics Report 2033. Data Horizon Research.