CLINICAL TRIALS PROFILE FOR COGENTIN

All Clinical Trials for COGENTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00964886 ↗	Efficacy of Antidepressants in Chronic Back Pain	Completed	University of California, San Diego	Phase 2	2010-01-01	This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.
NCT00802100 ↗	Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia	Completed	National Institute of Mental Health (NIMH)	Phase 4	2008-12-01	This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of other medications to limit treatment side effects, in adults with schizophrenia.
NCT00457366 ↗	A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room	Completed	AstraZeneca	Phase 4	2006-05-01	In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.
NCT00457366 ↗	A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room	Completed	University of Southern California	Phase 4	2006-05-01	In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.
NCT00018200 ↗	Effect of Antidepressants on Back Pain	Completed	US Department of Veterans Affairs	Phase 2	1999-04-01	The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.
NCT00018200 ↗	Effect of Antidepressants on Back Pain	Completed	VA Office of Research and Development	Phase 2	1999-04-01	The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.

Clinical Trial Conditions for COGENTIN

Condition Name

Condition Name for COGENTIN
Intervention	Trials
Back Pain	2
Peripheral Neuropathy	1
Schizophrenia	1
Sciatica	1

Condition MeSH

Condition MeSH for COGENTIN
Intervention	Trials
Back Pain	2
Sciatica	1
Peripheral Nervous System Diseases	1
Cognitive Dysfunction	1

Clinical Trial Locations for COGENTIN

Trials by Country

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Trials by Country for COGENTIN
Location	Trials
United States	14
Egypt	1

Trials by US State

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−

Trials by US State for COGENTIN
Location	Trials
California	4
Texas	1
North Carolina	1
New York	1
Minnesota	1

Clinical Trial Progress for COGENTIN

Clinical Trial Phase

Clinical Trial Phase for COGENTIN
Clinical Trial Phase	Trials
Phase 4	2
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for COGENTIN
Clinical Trial Phase	Trials
Completed	4
Enrolling by invitation	1

Clinical Trial Sponsors for COGENTIN

Sponsor Name

Sponsor Name for COGENTIN
Sponsor	Trials
VA Office of Research and Development	2
US Department of Veterans Affairs	1
AstraZeneca	1

Sponsor Type

Sponsor Type for COGENTIN
Sponsor	Trials
U.S. Fed	3
Other	3
Industry	1

Clinical Trials, Market Analysis, and Projections for Cogentin (Benztropine Mesylate)

Introduction to Cogentin (Benztropine Mesylate)

Cogentin, known by its generic name benztropine mesylate, is an anticholinergic medication commonly used to treat the motor symptoms of Parkinson's disease and other conditions such as extrapyramidal symptoms. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Historical Trials

A notable clinical trial conducted in 1980 in Texas compared benztropine mesylate against a placebo in patients with mild to moderate Parkinson’s disease who were also taking Sinemet (carbidopa and levodopa). The trial involved 29 participants and showed that benztropine mesylate improved symptoms in some patients, although the outcomes were mixed. Ten participants reported greater improvements with benztropine than with the placebo, while three reported better outcomes with the placebo, and the rest had similar responses to both treatments[4].

Current Research Context

While there are no recent clinical trials specifically focused on benztropine mesylate, ongoing research in Parkinson's disease often includes anticholinergic drugs as part of the treatment regimen. For instance, studies on other drugs like UCB0599, which targets early-stage Parkinson’s disease, highlight the ongoing efforts to improve treatment options for Parkinson’s patients. These studies often involve complex trial designs, including genetic screening and long-term follow-up to assess disease progression[1].

Market Analysis

Market Size and Growth

The benztropine mesylate market is part of the broader anticholinergic drug market, which is experiencing significant growth. The anticholinergic drug market is driven by factors such as technological advancements in drug manufacturing, the increasing prevalence of chronic diseases, and an aging population. Specifically, the benztropine mesylate market is expected to register a Compound Annual Growth Rate (CAGR) of 4.5% from 2023 to 2031[2].

Segmentation and Regional Insights

The market is segmented by route of administration, with the oral segment accounting for the highest revenue in 2023. The Asia Pacific region dominated the benztropine mesylate market in 2023, followed by North America, which also holds a significant share due to favorable reimbursement policies and the presence of major industry players[2].

Key Players

Major players operating in the benztropine mesylate market include Akorn, Zydus Pharmaceuticals, ANI Pharmaceuticals, PLIVA, and Fresenius Kabi. These companies play a crucial role in ensuring the high availability and quality of the drug[2].

Market Drivers and Challenges

Drivers

• Emerging Evidence and Awareness: Increasing awareness about age-related and neurological disorders is driving the demand for anticholinergic drugs like benztropine mesylate.
• Growing Old Population: The aging population is more susceptible to chronic diseases such as Parkinson’s disease, COPD, and overactive bladder, which are managed with anticholinergic drugs.
• Prevalence of Parkinson's Disease: The rising prevalence of Parkinson’s disease, with approximately 90,454 cases in the U.S. in 2023, contributes to the growing demand for benztropine mesylate[5].

Challenges

• Side Effects and Safety Concerns: Anticholinergic drugs, including benztropine mesylate, can have side effects such as dry mouth, constipation, and cognitive impairment, which can limit their use.
• Competition from New Treatments: The development of new treatments for Parkinson’s disease and other conditions could potentially reduce the market share of traditional anticholinergic drugs like benztropine mesylate.

Technological Advancements and Future Trends

Technological Advancements

Technological advancements in drug development, such as 3D printing, artificial intelligence (AI), machine learning (ML), and the Internet of Things (IoT), are expected to enhance the production of more effective and safer anticholinergic medications. These technologies can improve the precision and efficiency of drug manufacturing, potentially leading to better patient outcomes[5].

Patient-Centric Approaches

The trend towards patient-centric trial designs and the adoption of virtual and decentralized clinical trials is expected to improve patient participation and satisfaction. This approach can also broaden the pool of potential participants and enhance trial diversity, which could benefit the development and testing of anticholinergic drugs like benztropine mesylate[3].

Regional Market Growth

North America

North America, particularly the U.S. and Canada, is a significant market for benztropine mesylate due to favorable reimbursement policies and the presence of major industry players. The region is expected to continue driving market growth due to these factors[2].

Asia Pacific

The Asia Pacific region is expected to grow at a rapid pace due to the large patient pool, low cost of conducting clinical trials, and the availability of FDA-approved facilities. Countries such as China, India, Japan, and South Korea are key drivers of this growth[2].

Key Takeaways

• Clinical Trials: While specific recent trials on benztropine mesylate are limited, ongoing research in Parkinson’s disease involves anticholinergic drugs as part of treatment regimens.
• Market Growth: The benztropine mesylate market is expected to grow at a CAGR of 4.5% from 2023 to 2031, driven by increasing awareness of neurological disorders and an aging population.
• Technological Advancements: Advances in drug manufacturing and patient-centric trial designs are expected to enhance the efficacy and safety of anticholinergic drugs.
• Regional Insights: The Asia Pacific region and North America are key markets, with the former expected to grow rapidly due to a large patient pool and favorable clinical trial conditions.

FAQs

What is the primary use of benztropine mesylate?

Benztropine mesylate, known by the brand name Cogentin, is primarily used to treat the motor symptoms of Parkinson’s disease and extrapyramidal symptoms.

What is the expected market growth rate for benztropine mesylate?

The benztropine mesylate market is expected to register a CAGR of 4.5% from 2023 to 2031.

Which regions dominate the benztropine mesylate market?

The Asia Pacific region and North America are the dominant markets for benztropine mesylate, with the Asia Pacific region expected to grow at a faster rate.

What are the major drivers of the benztropine mesylate market?

The market is driven by emerging evidence and awareness regarding age and neurological disorders, a growing old population, and the prevalence of Parkinson’s disease.

What are some of the challenges faced by the benztropine mesylate market?

Challenges include side effects and safety concerns associated with anticholinergic drugs and competition from new treatments for Parkinson’s disease and other conditions.

How do technological advancements impact the benztropine mesylate market?

Technological advancements in drug development and patient-centric trial designs are expected to enhance the production and efficacy of anticholinergic drugs, improving patient outcomes and market growth.

Sources

1. Parkinson Study Group - Clinical Trial Updates - Parkinson Study Group
2. The Insight Partners - Benztropine Mesylate Market SWOT Analysis by 2031
3. Biospace - Oncology Clinical Trials Market Size Expected to Reach USD 22.11 ...
4. Parkinson's News Today - Benztropine mesylate for Parkinson's disease
5. Fortune Business Insights - Anticholinergic Drug Market Size, Share, Growth, Forecast, 2032