CLINICAL TRIALS PROFILE FOR AMITRIPTYLINE HYDROCHLORIDE

All Clinical Trials for AMITRIPTYLINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000428 ↗	Combining N-of-1 Trials to Assess Fibromyalgia Treatments	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 4	2000-09-01	This study will compare the effectiveness of combination therapy with the drugs amitriptyline and fluoxetine (AM+FL) and amitriptyline (AM) alone in the treatment of people with fibromyalgia. Doctors will treat each study participant with both AM + FL and AM alone for 6 weeks at a time. The study uses a method that combines results from treatment of individual patients to assess overall treatment effectiveness and help individual patients and their physicians with their treatment decisions. This study will also help compare the results of community-based studies (studies involving private doctors) and studies based at clinical research centers.
NCT00000428 ↗	Combining N-of-1 Trials to Assess Fibromyalgia Treatments	Completed	Tufts Medical Center	Phase 4	2000-09-01	This study will compare the effectiveness of combination therapy with the drugs amitriptyline and fluoxetine (AM+FL) and amitriptyline (AM) alone in the treatment of people with fibromyalgia. Doctors will treat each study participant with both AM + FL and AM alone for 6 weeks at a time. The study uses a method that combines results from treatment of individual patients to assess overall treatment effectiveness and help individual patients and their physicians with their treatment decisions. This study will also help compare the results of community-based studies (studies involving private doctors) and studies based at clinical research centers.
NCT00000793 ↗	A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection	Completed	Boehringer Ingelheim	Phase 2	1969-12-31	To assess the efficacy, safety, and tolerability of amitriptyline hydrochloride versus mexiletine hydrochloride in reducing pain intensity in patients with HIV-related painful peripheral neuropathy. No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related neuropathy have been attempted. Both amitriptyline and mexiletine have been useful in the management of painful neuropathies; however, both are associated with certain toxicities. In this comparative study of amitriptyline and mexiletine, benztropine mesylate also will be included as an active placebo to mimic the side effects of the study drugs.
NCT00000793 ↗	A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To assess the efficacy, safety, and tolerability of amitriptyline hydrochloride versus mexiletine hydrochloride in reducing pain intensity in patients with HIV-related painful peripheral neuropathy. No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related neuropathy have been attempted. Both amitriptyline and mexiletine have been useful in the management of painful neuropathies; however, both are associated with certain toxicities. In this comparative study of amitriptyline and mexiletine, benztropine mesylate also will be included as an active placebo to mimic the side effects of the study drugs.
NCT00000817 ↗	The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1994-11-01	To evaluate the separate and combined efficacy of a standardized acupuncture regimen and amitriptyline on the relief of pain due to peripheral neuropathy and on the quality of life of HIV-infected patients. Both amitriptyline, an antidepressant, and acupuncture, a Chinese medical approach that uses needles to relieve pain, have been used successfully to reduce pain in some people. It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection.
NCT00006427 ↗	Chronic Pain After Amputation	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	1996-08-01	This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation

Clinical Trial Conditions for AMITRIPTYLINE HYDROCHLORIDE

Condition Name

Condition Name for AMITRIPTYLINE HYDROCHLORIDE
Intervention	Trials
Migraine	14
Fibromyalgia	11
Pain	9
Headache	7

Condition MeSH

Condition MeSH for AMITRIPTYLINE HYDROCHLORIDE
Intervention	Trials
Migraine Disorders	18
Depression	14
Neuralgia	13
Myofascial Pain Syndromes	12

Clinical Trial Locations for AMITRIPTYLINE HYDROCHLORIDE

Trials by Country

Trials by Country for AMITRIPTYLINE HYDROCHLORIDE
Location	Trials
United States	162
Brazil	12
Canada	12
Germany	12
France	5

Trials by US State

Trials by US State for AMITRIPTYLINE HYDROCHLORIDE
Location	Trials
Washington	9
Ohio	9
New York	9
Pennsylvania	7
Minnesota	7

Clinical Trial Progress for AMITRIPTYLINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for AMITRIPTYLINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	28
Phase 3	24
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for AMITRIPTYLINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	65
Unknown status	16
Recruiting	15

Clinical Trial Sponsors for AMITRIPTYLINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for AMITRIPTYLINE HYDROCHLORIDE
Sponsor	Trials
Federal University of São Paulo	4
Children's Hospital Medical Center, Cincinnati	4
University of Washington	3

Sponsor Type

Sponsor Type for AMITRIPTYLINE HYDROCHLORIDE
Sponsor	Trials
Other	153
Industry	26
NIH	20

AMITRIPTYLINE HYDROCHLORIDE Market Analysis and Financial Projection

Amitriptyline Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Amitriptyline Hydrochloride

Amitriptyline Hydrochloride is a tricyclic antidepressant that has been widely used since its approval in 1961. It is primarily used to treat major depressive disorder, various pain syndromes, and other neurological conditions. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Erythromelalgia Trial

One of the notable ongoing clinical trials involves the use of Amitriptyline Hydrochloride in the form of a skin-applied treatment called ATX01 for patients with erythromelalgia. This condition is characterized by severe pain, redness, and warmth in the hands and feet, often triggered by heat or exercise.

• Trial Design: The EASE trial is a Phase 2 study that compares ATX01 cream against a placebo. Participants apply the treatment twice daily over two 3-week periods, with a wash-out period in between. The primary goal is to assess whether ATX01 reduces the severity of pain attacks more effectively than a placebo[1].
• Eligibility: Participants must have a documented diagnosis of erythromelalgia, experience an average pain intensity of 4-9 on the NPRS scale, and have at least four pain attacks per week. They must also have stable medication doses for four weeks prior to the study, except for topical agents[1].

Other Ongoing Trials

Amitriptyline Hydrochloride is also being investigated in various other Phase 2 trials for conditions such as pain, neoplasms, and post-COVID-19 symptoms.

• Pain Management: Trials are ongoing to evaluate the efficacy of Amitriptyline Hydrochloride in managing different types of pain, including neuropathic pain and fibromyalgia[4].
• Neoplasms: There are Phase 2 trials examining the use of Amitriptyline Hydrochloride in patients with neoplasms, conducted in several countries including the US, Germany, Belgium, and others[4].
• Post-COVID-19 Symptoms: Amitriptyline has been found effective in treating post-COVID-19 symptoms such as headaches and migraines, indicating potential future applications in this area[3].

Market Analysis

Current Market Size and Growth

The global Amitriptyline Hydrochloride market is substantial and growing. Here are some key points:

• Market Size: As of 2023, the global Amitriptyline market is estimated to be valued at approximately US$ 607.0 million[3].
• Growth Rate: The market is expected to exhibit a compound annual growth rate (CAGR) of 5.6% from 2024 to 2030[3].
• Regional Analysis: North America is expected to dominate the market, driven by factors such as increased product approvals by regulatory authorities and a higher prevalence of mental disorders[3].

Drivers of Market Growth

Several factors are driving the growth of the Amitriptyline Hydrochloride market:

• Increasing Prevalence of Mental Disorders: The rise in mental health issues such as depression, anxiety, and other mood disorders is a significant driver. According to the World Health Organization (WHO), an estimated 5% of adults globally suffer from depression[3].
• Product Approvals: Regulatory approvals, such as the Abbreviated New Drug Application (ANDA) approval for Amitriptyline HCl Tablets by the U.S. FDA, are boosting market growth[3].
• Affordability and Effectiveness: The demand for generic versions of Amitriptyline Hydrochloride, which are more affordable and equally effective, is also contributing to market expansion[5].

Market Restraints

Despite the growth, there are some restraints to consider:

• Side Effects: Amitriptyline Hydrochloride is associated with various side effects such as nausea, vomiting, drowsiness, and others, which can shift patient preference to alternative treatments[3].
• COVID-19 Impact: While the COVID-19 pandemic has increased the prevalence of mental disorders, it has also highlighted the need for alternative treatments with fewer side effects[3].

Market Projections

Future Market Size and Growth

The future outlook for the Amitriptyline Hydrochloride market is promising:

• Projected Market Size: The Amitriptyline HCl Tablets Market is projected to reach USD 2.3 billion by 2030, growing at a CAGR of 8.2% from 2024 to 2030[5].
• Regional Expansion: The market is expected to grow significantly in emerging economies due to rising disposable incomes, urbanization, and the need for cost-effective treatments[5].

Trends and Forecast

Key trends and forecasts include:

• Rising Demand for Generics: The demand for generic versions of Amitriptyline Hydrochloride is expected to continue, driven by their affordability and effectiveness[5].
• Technological Advancements: Developing technologies and new formulations, such as the skin-applied treatment ATX01, are expected to further drive market growth[1][5].
• Legislative Support: Sustainability trends and legislative backing for affordable medications will make the market a priority for investors and industry participants in the coming years[5].

Key Takeaways

• Clinical Trials: Ongoing trials, particularly for erythromelalgia and other pain conditions, show promise for new applications of Amitriptyline Hydrochloride.
• Market Growth: The global market is expected to grow at a CAGR of 5.6% to 8.2% from 2024 to 2030, driven by increasing prevalence of mental disorders and demand for generics.
• Regional Dominance: North America is expected to dominate the market, but emerging economies will also see significant growth.
• Side Effects and Alternatives: Despite growth, the market faces restraints due to side effects, which may drive the development of alternative treatments.

FAQs

What is Amitriptyline Hydrochloride used for?

Amitriptyline Hydrochloride is primarily used to treat major depressive disorder, various pain syndromes such as neuropathic pain and fibromyalgia, and other neurological conditions.

What are the potential side effects of Amitriptyline Hydrochloride?

Common side effects include nausea, vomiting, drowsiness, weakness or tiredness, nightmares, headaches, dry mouth, constipation, and changes in sex drive.

What is the current market size of Amitriptyline Hydrochloride?

As of 2023, the global Amitriptyline market is estimated to be valued at approximately US$ 607.0 million.

What is the projected growth rate of the Amitriptyline Hydrochloride market?

The market is expected to exhibit a CAGR of 5.6% to 8.2% from 2024 to 2030.

Are there any ongoing clinical trials for Amitriptyline Hydrochloride?

Yes, there are ongoing Phase 2 trials for conditions such as erythromelalgia, pain management, neoplasms, and post-COVID-19 symptoms.

Sources

1. Amitriptyline for Erythromelalgia Clinical Trial 2024 | Power - https://www.withpower.com/trial/phase-2-erythromelalgia-5-2023-51057
2. Amitriptyline Hydrochloride Market Report 2024 (Global Edition) - https://www.cognitivemarketresearch.com/amitriptyline-hydrochloride-market-report
3. Amitriptyline Market Size, Trends and Forecast to 2030 - https://www.coherentmarketinsights.com/market-insight/amitriptyline-market-4226
4. Amitriptyline Hydrochloride - Drug Targets, Indications, Patents - https://synapse.patsnap.com/drug/42f37c1d71954cf88c0db51eda8317ab
5. Amitriptyline HCl Tablets Market Key Drivers and Forecast 2025-2032 - https://github.com/kaira1218/echo-insights/blob/main/Amitriptyline%20HCl%20Tablets%20Market%20Key%20Drivers%20and%20Forecast%202025-2032.md