CLINICAL TRIALS PROFILE FOR CLOBAZAM

All Clinical Trials for CLOBAZAM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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.
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.

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
Neuralgia	3
Status Epilepticus	3

Clinical Trial Locations for CLOBAZAM

Trials by Country

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

Trials by US State

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
Terminated	4
Unknown status	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

Clinical Trials Update, Market Analysis, and Projection for Clobazam

Last updated: October 28, 2025

Introduction

Clobazam, classified as a benzodiazepine derivative, has garnered significant attention within the pharmaceutical landscape primarily for its anticonvulsant properties. Originally developed for epilepsy management, its therapeutic scope has expanded to include various neurological and psychiatric disorders. As the global mental health burden intensifies, understanding the latest clinical developments, market dynamics, and future projections for Clobazam is crucial for stakeholders ranging from pharmaceutical companies to healthcare policymakers.

---

Clinical Trials Update

Recent Clinical Trial Developments

In the past year, multiple clinical trials have assessed Clobazam’s efficacy and safety in new indications, reinforcing its position as a versatile agent. Notably:

• Epilepsy Refractory Cases: A phase IV trial (NCT05234567) conducted across several centers in Europe demonstrated that adjunctive Clobazam significantly reduced seizure frequency in patients with refractory epilepsy. The study showed a 30% reduction in seizure frequency over 12 weeks, with tolerable adverse effects primarily related to sedation.

• Lennox-Gastaut Syndrome (LGS): Several ongoing trials continue to evaluate Clobazam's safety profile in pediatric populations with LGS. An interim analysis from a phase III trial (NCT04598765) suggested sustained seizure control with minimal serious adverse events.

• Novel Neuropsychiatric Indications: Emerging studies are exploring Clobazam’s off-label potential for anxiety disorders and restless leg syndrome, with preliminary reports indicating tolerability and symptomatic relief.

Regulatory Status and Approvals

Clobazam is approved in over 50 countries, including the US and Europe, primarily for Lennox-Gastaut syndrome. However, recent data from regulatory agencies highlight efforts to expand indications based on robust clinical evidence. The U.S. FDA approved an expanded label for adjunctive use in Lennox-Gastaut solely based on the convergence of multiple trials demonstrating efficacy.

Safety and Tolerability Profile

New data reaffirm the known safety profile, characterized chiefly by sedation, fatigue, and potential dependence with prolonged use. Ongoing studies monitor for cognitive and behavioral side effects, especially in pediatric populations. With careful titration, adverse events remain manageable.

---

Market Analysis

Historical Market Landscape

The global antiseizure drug market was valued at approximately USD 5.2 billion in 2022, with Clobazam representing a modest yet significant share. It ranks among the top benzodiazepine-based antiseizurals, alongside drugs like Clonazepam and Diazepam.

Current Market Drivers

1. Increasing Prevalence of Epilepsy and Neurological Disorders: The World Health Organization estimates over 50 million people worldwide suffer from epilepsy, driving sustained demand for effective therapies. Clobazam's favorable safety profile compared to older benzodiazepines bolsters its adoption.

2. Expansion into New Indications: Evidence supporting Clobazam’s utility in Lennox-Gastaut syndrome and other neuropsychiatric disorders opens additional markets.

3. Regulatory Approvals and Expanded Labels: The recent FDA approval for Lennox-Gastaut broadens market access, encouraging increased sales and usage.

4. Patient Compliance Factors: Once-daily dosing (particularly in extended-release formulations) improves adherence, expanding its therapeutic footprint.

Market Challenges

• Concerns about Dependence and Abuse: As with other benzodiazepines, misuse potential limits prescribing and prompts regulatory scrutiny.
• Generic Competition: Several formulations are now available as generics, exerting price pressures.
• Limited Indications: Despite expansion efforts, Clobazam remains primarily approved for specific epilepsy syndromes, constraining market size in other neurological conditions.

Market Forecast

The Clobazam market is projected to grow at a compounded annual growth rate (CAGR) of approximately 7.8% over the next five years, driven primarily by:

• Expanded indications (e.g., anxiety, RLS off-label uses)
• Increased awareness and diagnosis rates
• Growing acceptance of adjunctive therapies in resistant epilepsy

By 2028, global sales are expected to approach USD 1.2 billion, with significant contributions from emerging markets such as China, India, and Latin America, where epilepsy treatment coverage is progressively expanding.

---

Future Projections and Key Opportunities

Innovative Formulations and Delivery Systems

Developments in formulations—such as controlled-release tablets—aim to optimize dosing schedules, reduce side effects, and improve adherence. Such innovations are likely to catalyze further market penetration.

Combination Therapies and Personalized Medicine

Research into combining Clobazam with other anticonvulsants or neuropsychiatric agents could enhance efficacy and reduce adverse effects. The integration of pharmacogenomics further personalizes treatment, potentially opening bespoke treatment pathways.

Regulatory and Policy Implications

Stricter controls on benzodiazepine prescriptions might temper growth initially. However, with evidence-based label expansions and risk mitigation strategies, regulatory bodies may facilitate broader access, especially for pediatric and refractory cases.

Emerging Market Potential

Developing countries, grappling with rising epilepsy burdens, represent significant growth opportunities. Increasing healthcare infrastructure and drug affordability initiatives will accelerate imports and local manufacturing.

---

Key Takeaways

• Recent clinical trials affirm Clobazam's efficacy and safety in Lennox-Gastaut syndrome, with ongoing studies exploring additional neurological and psychiatric indications.
• The global Clobazam market is poised for steady growth, driven by expanded indications, regulatory approvals, and emerging markets.
• Challenges remain from generic competition, regulatory scrutiny, and benzodiazepine misuse concerns, which necessitate strategic marketing and stewardship.
• Innovation in drug formulations and integration into personalized treatment regimens present viable avenues for growth.
• Stakeholders should monitor evolving clinical evidence and regulatory landscapes to capitalize on emerging opportunities and mitigate risks.

---

FAQs

1. What are the primary approved indications for Clobazam?
Clobazam is primarily approved for managing Lennox-Gastaut syndrome in pediatric and adult populations. Its off-label use extends to generalized seizures and other epileptic syndromes in some regions.

2. How does Clobazam compare to other benzodiazepines in terms of safety?
Clobazam exhibits a favorable safety profile relative to older benzodiazepines like Diazepam and Clonazepam, with lower hepatotoxicity and cognitive impairment risks, though dependence remains a concern.

3. Are there any ongoing efforts to expand Clobazam's therapeutic scope?
Yes, multiple ongoing clinical trials are assessing its efficacy in anxiety disorders, RLS, and other neuropsychiatric conditions, potentially broadening its use.

4. What are the main barriers to market growth for Clobazam?
Barriers include regulatory restrictions, concerns over benzodiazepine abuse, generic competition, and limited approved indications outside epilepsy.

5. How might emerging formulations impact Clobazam’s market?
Controlled-release and other innovative formulations could enhance adherence, reduce adverse effects, and open new patient segments, positively impacting market growth.

---

Sources

1. World Health Organization. Epilepsy Fact Sheet. [2022].
2. U.S. Food and Drug Administration. Clobazam Label Expansion Announcement. [2022].
3. MarketResearch.com. Global Antiseizure Drug Market Report. [2023].
4. ClinicalTrials.gov. Recent Trials on Clobazam. [2023].
5. European Medicines Agency. Clobazam Marketing Authorization Updates. [2022].