CLINICAL TRIALS PROFILE FOR CLOBAZAM

All Clinical Trials for CLOBAZAM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01179828 ↗	Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio)	Completed	Aalborg University	Phase 3	2010-07-01	Drug therapy in patients with chronic low back pain is a major challenge for physicians. One of the problems is the lacking knowledge in prediction of drug efficacy in a chosen patient. Usually one of the classes of pain medication is given to patients with a similar clinical picture, although different pain mechanisms may be responsible for this clinical picture. Another reason for variable drug efficacy are genetic polymorphisms, this may be the reason why an unique drug produces different responses (from a lacking analgesic effect up to excessive effect or side-effects. Quantitative sensory testing is a method that documents alterations in the pain perception system. Linking genetic polymorphisms to quantitative sensory testing may give us a tool for anticipation of drug efficacy.
NCT01179828 ↗	Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio)	Completed	University of Bern	Phase 3	2010-07-01	Drug therapy in patients with chronic low back pain is a major challenge for physicians. One of the problems is the lacking knowledge in prediction of drug efficacy in a chosen patient. Usually one of the classes of pain medication is given to patients with a similar clinical picture, although different pain mechanisms may be responsible for this clinical picture. Another reason for variable drug efficacy are genetic polymorphisms, this may be the reason why an unique drug produces different responses (from a lacking analgesic effect up to excessive effect or side-effects. Quantitative sensory testing is a method that documents alterations in the pain perception system. Linking genetic polymorphisms to quantitative sensory testing may give us a tool for anticipation of drug efficacy.
NCT01011036 ↗	Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers	Completed	University Hospital Inselspital, Berne	Phase 3	2009-12-01	The investigators will use an intradermal capsaicin injection in the forearm to induce a state of localized pain. This localized pain will be measured by different means, and analysed locally and distally by so called quantitative sensory testing. The primary endpoint of measure is the difference in pain perception with and without benzodiazepines/GABA-Agonists around the injection point of capsaicin. The secondary endpoints are to measure pain modulation locally and distally by different quantitative tests as electricity, pressure pain thresholds, and ice water tests. The investigators' hypothesis is that clobazam induces higher pain thresholds as placebo and less sedation than the control medication clonazepam.
NCT00518713 ↗	Clobazam in Patients With Lennox-Gastaut Syndrome	Completed	Lundbeck LLC	Phase 3	2007-08-01	The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly assigned to either a low, medium or high dose, or placebo. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, patients will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.
NCT01160770 ↗	Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome	Completed	Lundbeck LLC	Phase 3	2005-12-01	The objective of this study is to evaluate the long-term safety and effectiveness of open-label clobazam in the treatment of drop seizures in subjects with LGS.
NCT00162981 ↗	Clobazam in Subjects With Lennox-Gastaut Syndrome	Completed	Lundbeck LLC	Phase 2	2005-10-01	The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.

Clinical Trial Conditions for CLOBAZAM

Condition Name

Condition Name for CLOBAZAM
Intervention	Trials
Epilepsy	10
Neuropathic Pain	3
Dravet Syndrome	3
Epilepsy, Generalized	2

Condition MeSH

Condition MeSH for CLOBAZAM
Intervention	Trials
Epilepsy	13
Syndrome	4
Lennox Gastaut Syndrome	3
Neuralgia	3

Clinical Trial Locations for CLOBAZAM

Trials by Country

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Trials by Country for CLOBAZAM
Location	Trials
United States	64
India	11
Switzerland	5
United Kingdom	4
Australia	2

Trials by US State

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−

Trials by US State for CLOBAZAM
Location	Trials
Texas	5
Massachusetts	5
Florida	5
Minnesota	4
California	4

Clinical Trial Progress for CLOBAZAM

Clinical Trial Phase

Clinical Trial Phase for CLOBAZAM
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	10
Phase 2	5

Clinical Trial Status

Clinical Trial Status for CLOBAZAM
Clinical Trial Phase	Trials
Completed	12
Unknown status	4
Terminated	4

Clinical Trial Sponsors for CLOBAZAM

Sponsor Name

Sponsor Name for CLOBAZAM
Sponsor	Trials
Lundbeck LLC	5
H. Lundbeck A/S	4
GW Research Ltd	3

Sponsor Type

Sponsor Type for CLOBAZAM
Sponsor	Trials
Other	37
Industry	16

Clobazam: Clinical Trials, Market Analysis, and Projections

Introduction to Clobazam

Clobazam, an antiepileptic drug and a benzodiazepine derivative, is primarily used to treat seizures associated with Lennox-Gastaut syndrome (LGS) and other seizure disorders. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Phase I, II, and III Trials

Clobazam has undergone extensive clinical trials to establish its efficacy and safety. Phase I trials demonstrated the drug's tolerability and efficacy. Phase II trials, conducted by Lundbeck between October 2005 and October 2006, were randomized and double-blind, involving 68 patients across ten study centers in the US. The primary outcome was the reduction in drop seizures over 15 weeks, with secondary outcomes including parent/caregiver global evaluations and overall seizure rate reduction[1].

The pivotal Phase III trial, known as CONTAIN, was conducted between August 2007 and April 2010. This double-blind, placebo-controlled study involved more than 238 patients aged between two and 60 years. The trial showed that clobazam significantly reduced the average weekly rate of atonic, tonic, or myoclonic seizures, with over 50% of patients experiencing a reduction in seizures. Common adverse reactions included tiredness, drooling, fever, aggressive behavior, and constipation[1].

Ongoing and Long-Term Studies

In addition to the initial trials, there are ongoing studies focusing on the long-term safety and tolerability of clobazam. For instance, a clinical trial at the Mayo Clinic aims to investigate the long-term safety and tolerability of clobazam when administered for one year as adjunctive therapy in pediatric patients aged 1 to 16 years with Dravet Syndrome[4].

Market Analysis

Global Market Size and Growth

The global clobazam market is expected to grow significantly over the forecast period from 2024 to 2031. This growth is driven by several factors, including the increasing prevalence of epilepsy worldwide. According to the World Health Organization (WHO), approximately 50 million people are affected by epilepsy globally, with a considerable percentage experiencing refractory seizures[3].

Regional Market Dynamics

The market is segmented geographically, with North America, particularly the US and Canada, representing a significant segment due to the high prevalence of epilepsy and advanced healthcare infrastructure. Europe, Asia-Pacific, Latin America, and the Middle East and Africa also contribute to the global market, each with their own dynamics and growth prospects[3].

Key Players and Market Share

The global clobazam market includes major manufacturers such as Lupin Pharmaceuticals, ROSEMONT Pharma, Amneal, Merck KGaA, Breckenridge Pharmaceutical, Upsher-Smith, and Hikma. These companies play a crucial role in the market, with the top three vendors accounting for a significant percentage of the revenue in 2023[2].

Market Segmentation by Application

Clobazam is primarily used for treating epilepsy and anxiety disorders. The epilepsy segment is the most significant, given clobazam's anticonvulsant properties, which make it effective in managing various forms of epilepsy, including Lennox-Gastaut syndrome. The medication's effectiveness and relatively favorable safety profile compared to other antiepileptic drugs drive its adoption in neurologic practices[3].

Market Projections

Growth Drivers

Several factors are expected to drive the growth of the clobazam market:

• Increasing Prevalence of Epilepsy: The rising incidence of epilepsy worldwide is a significant driver. As healthcare providers seek effective treatment options, the demand for clobazam is likely to increase[3].
• Advancements in Drug Formulations: Innovations in pharmaceutical technology, such as oral dispersible tablets and liquid formulations, enhance the drug's bioavailability and patient adherence. These advancements are expected to expand market reach[3].
• Growing Awareness and Diagnosis of Neurological Disorders: Improved diagnostic techniques and growing awareness of neurological disorders are leading to more diagnoses and treatments, thereby increasing the demand for clobazam[3].
• Regulatory Support: Positive evaluations from health authorities like the FDA and EMA ensure broader market access and encourage innovation, ultimately benefiting patients and healthcare systems[3].

Market Size and Revenue

The global clobazam market is estimated to grow from its current size to reach significant revenue by 2030. The North American market, for example, is expected to increase at a compound annual growth rate (CAGR) during the forecast period of 2024 to 2030. Similar growth trends are anticipated in the Asia-Pacific and European markets[2][3].

Competitive Landscape

The market is characterized by strong competition among major manufacturers. The introduction of generic versions following patent expirations is expected to encourage healthy competition, leading to cost reductions for patients and further market expansion[2].

Future Outlook

Research and Clinical Trials

Ongoing research initiatives and clinical trials are actively shaping the clobazam market. Investigations into clobazam’s potential use for anxiety, panic disorders, and other therapeutic applications are driving product demand and broadening its clinical indications. Collaborations between pharmaceutical companies and research institutions are fueling innovation, presenting potential breakthroughs that could further expand the market[3].

Technological Trends

Advancements in pharmaceutical technology, including new delivery systems and formulations, are expected to continue enhancing the drug’s bioavailability and patient adherence. These innovations will attract healthcare professionals seeking effective and patient-friendly treatment options, thereby expanding market reach[3].

Key Takeaways

• Clinical Trials: Clobazam has demonstrated efficacy and safety in Phase I, II, and III trials, particularly in treating seizures associated with Lennox-Gastaut syndrome.
• Market Growth: The global clobazam market is expected to grow significantly driven by the increasing prevalence of epilepsy, advancements in drug formulations, and growing awareness of neurological disorders.
• Regional Dynamics: North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa are key regions contributing to the global market.
• Competitive Landscape: Major manufacturers like Lupin Pharmaceuticals and Merck KGaA play a significant role, with generic versions expected to increase competition.
• Future Outlook: Ongoing research and technological advancements are expected to further expand the market and broaden clobazam’s clinical indications.

FAQs

Q: What is clobazam primarily used for?

A: Clobazam is primarily used to treat seizures associated with Lennox-Gastaut syndrome (LGS) and other seizure disorders.

Q: What were the key findings of the Phase III CONTAIN trial for clobazam?

A: The Phase III CONTAIN trial showed that clobazam significantly reduced the average weekly rate of atonic, tonic, or myoclonic seizures in patients with LGS.

Q: Which regions are expected to drive the growth of the clobazam market?

A: North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa are expected to drive the growth of the clobazam market.

Q: What are the main drivers of the clobazam market growth?

A: The main drivers include the increasing prevalence of epilepsy, advancements in drug formulations, growing awareness of neurological disorders, and regulatory support.

Q: Are there ongoing clinical trials for clobazam?

A: Yes, there are ongoing clinical trials, such as the one at the Mayo Clinic, investigating the long-term safety and tolerability of clobazam in pediatric patients with Dravet Syndrome.

Sources

1. Clinical Trials Arena: Onfi (Clobazam) - Treatment for Lennox-Gastaut Syndrome.
2. QYResearch: Global Clobazam Market Research Report 2024.
3. Verified Market Research: Clobazam Market Size, Scope, Growth, Trends and Forecast.
4. Mayo Clinic: Clinical Trials - Mayo Foundation for Medical Education and Research.