CLINICAL TRIALS PROFILE FOR CLONAZEPAM

All Clinical Trials for clonazepam

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00282828 ↗	Improving Treatment Outcomes in Pharmacotherapy of Generalized Social Anxiety Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	2006-03-01	This study will compare the effectiveness of either adding clonazepam or placebo to standard treatment or switching to venlafaxine in treating generalized social anxiety disorder in individuals who have not responded to treatment with sertraline.
NCT00031317 ↗	Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression	Completed	National Institute of Mental Health (NIMH)	Phase 4	2002-02-01	The purpose of this study is to examine the safety and effectiveness of the drug combination paroxetine and clonazepam in treating people with panic disorder (PD) and major depression. The main goal in treating people with PD is to rapidly reduce symptom severity and improve functioning. While numerous drug therapies have been used to treat PD, these treatments are limited by variable response rates and suboptimal side effect profiles. Evidence suggests that clonazepam given with a selective serotonin reuptake inhibitor (SSRI) can facilitate a rapid reduction in PD symptoms. However, it is unclear whether comorbid depression influences treatment response to the clonazepam and SSRI regimen. This study will examine whether combined treatment with clonazepam and the SSRI paroxetine will accelerate clinical response in participants with PD and comorbid depression. This study will also examine whether the benefits of treatment will be sustained until the end of the study despite tapering of clonazepam at the midpoint of the study. Participants in this study will be screened with medical and psychiatric interviews, a physical examination, electrocardiogram (ECG), and blood tests. Participants will then be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus placebo (an inactive pill) for 12 weeks. Participants will have weekly clinic visits during which symptoms and drug side effects will be checked and an interview to evaluate panic disorder and depression symptoms will be conducted.
NCT00025740 ↗	Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	2001-10-01	Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that follows exposure to an extremely traumatic stressors. PTSD is associated with serious symptoms. While numerous approaches have been used to treat PTSD, these treatments have several limiting factors. This study will evaluate a combination of the drugs clonazepam and paroxetine for the treatment of PTSD symptoms. The main goal of treatment in patients with PTSD is to significantly reduce symptom severity and improve functioning. While numerous approaches have been used to treat PTSD, these treatments are limited by variable response rates, up to a 6-week lag period before clinical response, and sub-optimal side effect profile, including possible worsening of anxiety and insomnia prior to clinical response. The proposed study will examine whether combined treatment with a benzodiazepine (clonazepam) and a selective serotonin reuptake inhibitor (paroxetine) in patients with PTSD will accelerate the onset of clinical response. A second goal is to evaluate whether the rapid and clinically meaningful benefits are sustained until the end of the study, despite tapering off the benzodiazepine at the midpoint of the study. The safety and tolerability of a combination of paroxetine and clonazepam will be compared to paroxetine and placebo (an inactive pill) in the treatment of PTSD. Participants in this study will be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus a placebo for 12 weeks. Participants will have weekly clinic visits for the first 4 weeks of the study and every other week for the last 8 weeks. Symptoms of PTSD, anxiety, and depression will be evaluated and drug side effects will be noted during the follow-up visits.
NCT00238914 ↗	Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1999-08-01	The overall goal of this research project is to test a newly developed behavioral therapy to enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES: 1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE) Therapy. 2. Lifetime history of depression will predict dysphoria and non-compliance with naltrexone.
NCT00238914 ↗	Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1	Completed	New York State Psychiatric Institute	Phase 2	1999-08-01	The overall goal of this research project is to test a newly developed behavioral therapy to enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES: 1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE) Therapy. 2. Lifetime history of depression will predict dysphoria and non-compliance with naltrexone.
NCT00118417 ↗	Therapies for Treatment-Resistant Panic Disorder Symptoms	Completed	National Institute of Mental Health (NIMH)	Phase 2/Phase 3	1999-03-01	This study will determine the effectiveness of different treatments for panic disorder symptoms in individuals who still have symptoms after initial treatment with medication.
NCT00118417 ↗	Therapies for Treatment-Resistant Panic Disorder Symptoms	Completed	Massachusetts General Hospital	Phase 2/Phase 3	1999-03-01	This study will determine the effectiveness of different treatments for panic disorder symptoms in individuals who still have symptoms after initial treatment with medication.

Clinical Trial Conditions for clonazepam

Condition Name

Condition Name for clonazepam
Intervention	Trials
Schizophrenia	9
Burning Mouth Syndrome	7
Psychotic Disorders	5
Epilepsy	4

Condition MeSH

Condition MeSH for clonazepam
Intervention	Trials
Disease	16
Mental Disorders	11
Schizophrenia	9
Syndrome	9

Clinical Trial Locations for clonazepam

Trials by Country

+

−

Trials by Country for clonazepam
Location	Trials
United States	29
Spain	5
Korea, Republic of	4
Switzerland	4
Mexico	3

Trials by US State

+

−

Trials by US State for clonazepam
Location	Trials
New York	9
California	3
Massachusetts	3
Maryland	3
Ohio	3

Clinical Trial Progress for clonazepam

Clinical Trial Phase

Clinical Trial Phase for clonazepam
Clinical Trial Phase	Trials
Phase 4	26
Phase 3	7
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for clonazepam
Clinical Trial Phase	Trials
Completed	32
Unknown status	10
Recruiting	8

Clinical Trial Sponsors for clonazepam

Sponsor Name

Sponsor Name for clonazepam
Sponsor	Trials
Centro de Investigación Biomédica en Red de Salud Mental	5
National Institute of Mental Health (NIMH)	5
Instituto de Investigación Marqués de Valdecilla	5

Sponsor Type

Sponsor Type for clonazepam
Sponsor	Trials
Other	98
Industry	14
NIH	9

Clonazepam: Clinical Trials, Market Analysis, and Projections

Introduction to Clonazepam

Clonazepam, a benzodiazepine, is widely used for its anxiolytic, anticonvulsant, and muscle relaxant properties. It is prescribed for various conditions, including anxiety disorders, panic disorders, epilepsy, and sometimes for chronic pain management.

Clinical Trials and Efficacy

Myofascial Pain Syndrome

A clinical trial focusing on the use of clonazepam for myofascial pain syndrome (MFPS) involved 46 patients with chronic pain. The study indicated that clonazepam may have an antinociceptive effect for these patients. Patients were titrated with clonazepam starting from 0.5 mg per day, and the dose was increased every 2 days until partial pain relief was achieved or intolerable side effects occurred. The results showed that 28 patients experienced partial pain relief without a secondary diagnosis of neuropathic/deafferentation pain, highlighting the potential of clonazepam in managing MFPS[1].

Epilepsy

The efficacy of clonazepam as monotherapy for newly diagnosed epilepsy is less clear due to limited and low-certainty evidence from randomized controlled trials. A review by the Cochrane Library found no significant difference in efficacy and tolerability between clonazepam and other antiepileptic drugs like carbamazepine and ethosuximide. The studies were criticized for their poor quality, short follow-up periods, and low participant numbers, making it difficult to draw definitive conclusions on the use of clonazepam as monotherapy for epilepsy[4].

Market Analysis

Current Market Size and Growth

The global clonazepam market has experienced significant growth in recent years. As of 2023, the market size was estimated to be $1.37 billion and is projected to grow to $1.48 billion in 2024 at a compound annual growth rate (CAGR) of 7.9%. This growth is attributed to the increasing prevalence of anxiety disorders, rising cases of panic disorders, growing awareness about mental health, and higher prescription rates[2][3].

Future Projections

The clonazepam market is expected to continue its strong growth trajectory. By 2028, the market size is forecasted to reach $2.01 billion at a CAGR of 8%. Key drivers of this growth include the rising prevalence of epilepsy, an expanding elderly population, increased adoption of telemedicine, and growing awareness of mental health disorders. Other trends expected to influence the market include the expansion of digital health solutions, the development of innovative formulations, and advancements in biosimilar and biogeneric production[2][3].

Market Segmentation

The clonazepam market is segmented by type (tablets and injections), application (adult and child), and end-user (hospitals, homecare settings, and specialty clinics). This segmentation helps in understanding the diverse needs and preferences of different patient groups and healthcare settings[3].

Key Trends and Drivers

Increasing Prevalence of Mental Health Disorders

The growing prevalence of anxiety and panic disorders is a significant driver of the clonazepam market. For instance, a report by the American Psychiatric Association indicated that 43% of adults felt more anxious in 2024 compared to the previous year, highlighting the increasing demand for anxiolytic medications like clonazepam[2].

Expanding Elderly Population

The rising geriatric population is another factor contributing to the market growth. Elderly individuals are more likely to suffer from conditions such as epilepsy and anxiety disorders, thereby increasing the demand for clonazepam[2][3].

Telemedicine and Digital Health Solutions

The increased adoption of telemedicine and digital health solutions is expected to enhance access to clonazepam, particularly for patients in remote or underserved areas. This trend is likely to continue driving market growth in the coming years[2][3].

Challenges and Limitations

Side Effects and Tolerability

Clinical trials have highlighted that clonazepam can have significant side effects, such as sedation, which can lead to patient withdrawal from treatment. For example, in the MFPS trial, 9 out of 46 patients were withdrawn due to intolerable side effects[1].

Limited Evidence for Monotherapy in Epilepsy

The use of clonazepam as monotherapy for epilepsy is supported by limited and low-certainty evidence. This lack of robust clinical data hampers its widespread adoption for this indication[4].

Conclusion

Clonazepam remains a vital medication in the management of various neurological and psychiatric conditions. While clinical trials suggest its efficacy in certain areas like myofascial pain syndrome, the evidence for its use in epilepsy as monotherapy is limited. The market for clonazepam is expected to grow significantly, driven by increasing prevalence of mental health disorders, an expanding elderly population, and advancements in healthcare technology.

Key Takeaways

• Clonazepam shows promise in managing myofascial pain syndrome.
• The drug's efficacy as monotherapy for epilepsy is supported by limited evidence.
• The global clonazepam market is projected to grow to $2.01 billion by 2028.
• Key drivers include the rising prevalence of anxiety and epilepsy, an expanding elderly population, and increased adoption of telemedicine.
• Side effects and limited clinical evidence for certain indications remain challenges.

FAQs

What are the primary uses of clonazepam?

Clonazepam is primarily used for treating anxiety disorders, panic disorders, epilepsy, and sometimes for managing chronic pain conditions like myofascial pain syndrome.

What are the common side effects of clonazepam?

Common side effects include sedation, drowsiness, and in some cases, intolerable side effects that may lead to patient withdrawal from treatment.

How is the clonazepam market expected to grow?

The clonazepam market is expected to grow from $1.37 billion in 2023 to $2.01 billion by 2028 at a CAGR of 8%, driven by increasing prevalence of mental health disorders and other factors.

What are the key trends influencing the clonazepam market?

Key trends include the expansion of digital health solutions, the development of innovative formulations, and advancements in biosimilar and biogeneric production.

Is clonazepam effective as monotherapy for epilepsy?

There is limited and low-certainty evidence supporting the use of clonazepam as monotherapy for epilepsy, making it less clear compared to other indications.

Sources

1. Clonazepam Open Clinical Treatment Trial for Myofascial Syndrome - Academic.oup.com
2. Clonazepam Global Market Report 2024 - GII Research
3. Clonazepam Global Market Report 2024 - The Business Research Company
4. Clonazepam monotherapy for treating people with newly diagnosed epilepsy - Cochrane Library
5. Clonazepam - Market, Report Size, Worth, Revenue, Growth - Valuates Reports