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Last Updated: April 13, 2025

CLINICAL TRIALS PROFILE FOR KLONOPIN


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All Clinical Trials for KLONOPIN

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00652912 ↗ Bioavailability Study of Clonazepam ODT Under Fasting Conditions Completed Cetero Research, San Antonio Phase 1 2004-03-01 To compare the single-dose bioavailability of Clonazepam ODT 1 mg and Klonopin Wafers 1 mg ODT
NCT00652912 ↗ Bioavailability Study of Clonazepam ODT Under Fasting Conditions Completed Gatway Medical Research, Inc Phase 1 2004-03-01 To compare the single-dose bioavailability of Clonazepam ODT 1 mg and Klonopin Wafers 1 mg ODT
NCT00652639 ↗ Bioavailability Study of Clonazepam Tablets Under Fasting Conditions Completed Cetero Research, San Antonio Phase 1 2004-02-01 To compare the single-dose bioavailability of Clonazepam tablets 1 mg and Klonopin tablets 1 mg
NCT00652639 ↗ Bioavailability Study of Clonazepam Tablets Under Fasting Conditions Completed Par Pharmaceutical, Inc. Phase 1 2004-02-01 To compare the single-dose bioavailability of Clonazepam tablets 1 mg and Klonopin tablets 1 mg
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for KLONOPIN

Condition Name

22110-0.200.20.40.60.811.21.41.61.822.2Suicidal IdeationTo Determine Bioequivalence Under Fasting ConditionsMajor Depressive EpisodeSchizoaffective Disorder[disabled in preview]
Condition Name for KLONOPIN
Intervention Trials
Suicidal Ideation 2
To Determine Bioequivalence Under Fasting Conditions 2
Major Depressive Episode 1
Schizoaffective Disorder 1
[disabled in preview] 0
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Condition MeSH

3222000.511.522.53DiseaseDepressive Disorder, MajorDepressionSuicidal Ideation[disabled in preview]
Condition MeSH for KLONOPIN
Intervention Trials
Disease 3
Depressive Disorder, Major 2
Depression 2
Suicidal Ideation 2
[disabled in preview] 0
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Clinical Trial Locations for KLONOPIN

Trials by Country

+
Trials by Country for KLONOPIN
Location Trials
United States 5
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Trials by US State

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Trials by US State for KLONOPIN
Location Trials
New York 3
California 1
New Jersey 1
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Clinical Trial Progress for KLONOPIN

Clinical Trial Phase

50.0%16.7%16.7%16.7%00.811.21.41.61.822.22.42.62.833.2Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for KLONOPIN
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 1
[disabled in preview] 1
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Clinical Trial Status

62.5%25.0%12.5%0-0.500.511.522.533.544.555.5CompletedWithdrawnTerminated[disabled in preview]
Clinical Trial Status for KLONOPIN
Clinical Trial Phase Trials
Completed 5
Withdrawn 2
Terminated 1
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Clinical Trial Sponsors for KLONOPIN

Sponsor Name

trials0112233New York State Psychiatric InstituteCetero Research, San AntonioPar Pharmaceutical, Inc.[disabled in preview]
Sponsor Name for KLONOPIN
Sponsor Trials
New York State Psychiatric Institute 3
Cetero Research, San Antonio 2
Par Pharmaceutical, Inc. 2
[disabled in preview] 1
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Sponsor Type

70.6%17.6%11.8%0024681012OtherIndustryNIH[disabled in preview]
Sponsor Type for KLONOPIN
Sponsor Trials
Other 12
Industry 3
NIH 2
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Clinical Trials and Efficacy of Klonopin

Klonopin, known generically as clonazepam, is a benzodiazepine that has been extensively studied and used for various medical conditions, including panic disorder, seizure disorders, and other neurological and psychiatric conditions.

Clinical Trials for Panic Disorder

The efficacy of Klonopin in treating panic disorder was demonstrated in two double-blind, placebo-controlled studies involving adult outpatients with a primary diagnosis of panic disorder, with or without agoraphobia, as defined by the DSM-IIIR and later DSM-V criteria.

  • Study 1: This was a 9-week, fixed-dose study that included Klonopin doses of 0.5, 1, 2, 3, or 4 mg/day or placebo. The study consisted of four phases: a 1-week placebo lead-in, a 3-week upward titration, a 6-week fixed dose, and a 7-week discontinuance phase. The 1 mg/day group showed a significant difference from the placebo group, with a reduction of approximately 1 panic attack per week from baseline. At the endpoint, 74% of patients receiving 1 mg/day of clonazepam were free of full panic attacks, compared to 56% of placebo-treated patients[1][3].

  • Study 2: This was a 6-week, flexible-dose study involving Klonopin in a dose range of 0.5 to 4 mg/day or placebo. The study included a 1-week placebo lead-in, a 6-week optimal-dose phase, and a 6-week discontinuance phase. The mean clonazepam dose during the optimal dosing period was 2.3 mg/day. Similar to Study 1, there was a reduction of approximately 1 panic attack per week from baseline. At the endpoint, 62% of patients receiving clonazepam were free of full panic attacks, compared to 37% of placebo-treated patients[1][3].

Long-Term Use

The effectiveness of Klonopin in long-term use, beyond 9 weeks, has not been systematically studied in controlled clinical trials. Therefore, physicians are advised to periodically reevaluate the long-term usefulness of the drug for individual patients[1][3].

Other Clinical Uses

While Klonopin is FDA-approved primarily for the treatment of specific seizure disorders, such as the Lennox-Gastaut syndrome, it has also been used off-label for various other conditions, including chronic pain syndromes like myofascial pain syndrome. An open clinical treatment trial involving 46 patients with chronic pain associated with myofascial pain syndrome showed that clonazepam could provide partial pain relief, although this use is not FDA-approved[4].

Market Analysis and Projections for Klonopin

The market for Klonopin (clonazepam) is robust and growing, driven by several key factors.

Market Size and Growth

As of 2023, the clonazepam market was valued at approximately $1.37 billion and is projected to grow to $1.48 billion in 2024 at a compound annual growth rate (CAGR) of 7.9%. By 2028, the market is expected to reach $2.01 billion, maintaining a CAGR of 8%[2][5].

Another projection indicates that the market will grow from $2.5 billion in 2023 to $4.5 billion by 2031, at a CAGR of 3.2% from 2024 to 2031[5].

Market Segmentation

The clonazepam market is segmented by type, application, and end-user. The primary types include tablets and injections, with tablets being the most common form. The market is also segmented by application into adult and child uses, and by end-user into hospitals, homecare settings, and specialty clinics[2].

Regional Growth

North America was the largest region in the clonazepam market in 2023, but the Asia-Pacific region is expected to be the fastest-growing in the forecast period. Other significant regions include Western Europe, Eastern Europe, South America, the Middle East, and Africa[2].

Key Drivers

The growth in the clonazepam market can be attributed to several factors:

  • Increasing Prevalence of Anxiety Disorders: Rising cases of anxiety and panic disorders are driving the demand for clonazepam.
  • Growing Awareness of Mental Health: Increased awareness and reduced stigma around mental health issues are leading to higher prescription rates.
  • Expanding Therapeutic Applications: Clonazepam is being used off-label for various conditions, including chronic pain syndromes and other neurological disorders.
  • Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure and the adoption of telemedicine are also contributing to market growth[2][5].

Generic Versions and Pricing

Generic versions of clonazepam are significantly cheaper than the brand name Klonopin, making the drug more accessible to a wider population. For example, 100 tablets of 0.5 mg generic clonazepam can cost as low as $9.94, compared to the brand name which can cost around $278 for the same quantity[5].

Key Takeaways

  • Clinical Efficacy: Klonopin has been shown to be effective in treating panic disorder and certain seizure disorders, with significant reductions in panic attack frequency.
  • Market Growth: The clonazepam market is expected to grow significantly, driven by increasing prevalence of anxiety disorders, expanding therapeutic applications, and advancements in healthcare infrastructure.
  • Regional Trends: North America is currently the largest market, but the Asia-Pacific region is expected to be the fastest-growing.
  • Generic Availability: Generic versions of clonazepam are more affordable and widely available, increasing accessibility.

FAQs

Q: What is the primary use of Klonopin (clonazepam)?

A: Klonopin (clonazepam) is primarily used to treat anxiety disorders, panic disorders, epilepsy, and Lennox-Gastaut syndrome.

Q: How is the clonazepam market expected to grow in the coming years?

A: The clonazepam market is projected to grow from $1.37 billion in 2023 to $1.48 billion in 2024 and further to $2.01 billion by 2028, with a CAGR of 8%.

Q: What are the key drivers of the clonazepam market?

A: The key drivers include the increasing prevalence of anxiety disorders, expanding therapeutic applications, and advancements in healthcare infrastructure.

Q: How does the price of brand name Klonopin compare to its generic version?

A: The brand name Klonopin is significantly more expensive than its generic version, with generic versions costing as low as $9.94 for 10 tablets compared to $278 for 100 tablets of the brand name.

Q: What regions are expected to see significant growth in the clonazepam market?

A: North America is currently the largest market, but the Asia-Pacific region is expected to be the fastest-growing in the forecast period.

Sources

  1. Guideline Central: Klonopin - Drug Information from Guideline Central.
  2. The Business Research Company: Global Clonazepam Market Report 2024.
  3. FDA: KLONOPIN TABLETS (clonazepam) Rx only WARNING.
  4. Pain Medicine: Clonazepam Open Clinical Treatment Trial for Myofascial Syndrome.
  5. DrugPatentWatch: Market Analysis and Financial Projection for Klonopin (Clonazepam).

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