CLINICAL TRIALS PROFILE FOR ELAVIL

All Clinical Trials for ELAVIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00862095 ↗	Medical Therapies for Chronic Post-Traumatic Headaches	Terminated	U.S. Army Medical Research and Development Command	Phase 4	2008-06-01	To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in patients with chronic post-traumatic headaches.
NCT00862095 ↗	Medical Therapies for Chronic Post-Traumatic Headaches	Terminated	U.S. Army Medical Research and Materiel Command	Phase 4	2008-06-01	To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in patients with chronic post-traumatic headaches.
NCT00862095 ↗	Medical Therapies for Chronic Post-Traumatic Headaches	Terminated	Madigan Army Medical Center	Phase 4	2008-06-01	To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in patients with chronic post-traumatic headaches.
NCT00248651 ↗	Functional Dyspepsia Treatment Trial	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2006-10-01	Functional dyspepsia is a common gastrointestinal disorder. Symptoms can include stomach pain or discomfort, bloating, fullness after eating meals, and nausea. These symptoms often interfere with school and work, and weight loss may occur due to dietary restrictions. The hypothesis of this study was that antidepressant therapy is more effective than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity. The study also examined if antidepressant therapy reduces disability and improves quality of life in functional dyspepsia.
NCT00248651 ↗	Functional Dyspepsia Treatment Trial	Completed	Mayo Clinic	Phase 2/Phase 3	2006-10-01	Functional dyspepsia is a common gastrointestinal disorder. Symptoms can include stomach pain or discomfort, bloating, fullness after eating meals, and nausea. These symptoms often interfere with school and work, and weight loss may occur due to dietary restrictions. The hypothesis of this study was that antidepressant therapy is more effective than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity. The study also examined if antidepressant therapy reduces disability and improves quality of life in functional dyspepsia.
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.

Clinical Trial Conditions for ELAVIL

Condition Name

Condition Name for ELAVIL
Intervention	Trials
Headache	2
Autism Spectrum Disorder	1
Migraine	1
Brain Injuries	1

Condition MeSH

Condition MeSH for ELAVIL
Intervention	Trials
Headache	4
Migraine Disorders	2
Post-Traumatic Headache	2
Laryngitis	1

Clinical Trial Locations for ELAVIL

Trials by Country

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−

Trials by Country for ELAVIL
Location	Trials
United States	14
Canada	1
Ghana	1
Iran, Islamic Republic of	1

Trials by US State

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−

Trials by US State for ELAVIL
Location	Trials
Washington	2
Massachusetts	2
Ohio	1
New York	1
New Jersey	1

Clinical Trial Progress for ELAVIL

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for ELAVIL
Clinical Trial Phase	Trials
Completed	5
Terminated	2
Unknown status	2

Clinical Trial Sponsors for ELAVIL

Sponsor Name

Sponsor Name for ELAVIL
Sponsor	Trials
U.S. Army Medical Research and Materiel Command	1
National Institute of Neurological Disorders and Stroke (NINDS)	1
Madigan Army Medical Center	1

Sponsor Type

Sponsor Type for ELAVIL
Sponsor	Trials
Other	12
NIH	4
U.S. Fed	3

Amitriptyline (ELAVIL): Clinical Trials, Market Analysis, and Projections

Introduction

Amitriptyline, commonly known by its brand name ELAVIL, is a tricyclic antidepressant that has been widely used since its approval in 1961. It is utilized for a variety of conditions, including depressive disorders, neuralgia, and chronic neuropathic pain. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Recent Trials

Amitriptyline is currently being investigated in various clinical trials for different indications:

• Erythromelalgia: A Phase 2 trial is underway to test the efficacy of a skin-applied treatment called ATX01 (Amitriptyline Hydrochloride) for patients with erythromelalgia, a condition characterized by severe pain in the hands and feet. Participants apply the treatment twice daily to assess its effectiveness in reducing pain attacks compared to a placebo[4].

• Pain Management: Trials are also being conducted to evaluate the use of amitriptyline for pain management, including chronic neuropathic pain. These trials often compare the efficacy of amitriptyline against placebos or other treatments[1].

• Neoplasms: There are ongoing Phase 2 trials in several countries to investigate the use of amitriptyline in the context of neoplasms, although specific details on these trials are limited[1].

Trial Design and Objectives

The EASE trial, for example, involves a crossover design where participants are randomly assigned to either receive the ATX01 cream or a placebo for two 3-week periods, with a wash-out period in between. The primary objective is to determine if ATX01 reduces the severity of pain attacks more effectively than the placebo[4].

Market Analysis

Current Market Size and Growth

The global amitriptyline market was estimated to be valued at US$ 607.0 million in 2023. It is expected to exhibit a Compound Annual Growth Rate (CAGR) of 5.6% during the forecast period from 2023 to 2030, reaching a projected value of US$ 888.8 million by 2030[2].

Drivers of Market Growth

Several factors are driving the growth of the amitriptyline market:

• Regulatory Approvals: Increased product approvals by regulatory authorities, such as the U.S. FDA, are expected to boost market growth. For instance, Unichem Laboratories Ltd. received ANDA approval for its Amitriptyline HCl Tablets in 2021[2].

• COVID-19 Impact: The COVID-19 pandemic has had a positive impact on the market due to the increased use of amitriptyline to treat post-COVID-19 symptoms such as headaches and migraines. Additionally, the pandemic has led to a rise in mental health disorders, further increasing demand for antidepressants like amitriptyline[2].

• Prevalence of Mental Health Disorders: The rising prevalence of anxiety and depression globally is a significant driver for the expansion of the amitriptyline market. Increasing geriatric populations and healthcare expenditures also contribute to this growth[3].

Market Restraints

Despite the growth drivers, there are several restraints to the market:

• Side Effects: Amitriptyline is associated with various side effects, including nausea, vomiting, drowsiness, and changes in sex drive. These side effects can shift patient preferences towards alternative treatments, potentially hampering market growth[2].

• Competition: The presence of other antidepressants and pain management drugs in the market can also pose a challenge to the growth of amitriptyline sales[3].

Market Segmentation

By Strength

The global amitriptyline market is segmented by strength, with available doses ranging from 10mg to 150mg. This segmentation helps in catering to different patient needs and treatment protocols[3].

By Application

Amitriptyline is used for various applications, including migraine, nocturnal enuresis, chronic neuropathic pain, and depression. Each application segment has its own market dynamics and growth prospects[3].

By Demographic

The market is also segmented by demographic, including adult, pediatric, and geriatric populations. The geriatric segment is particularly significant due to the increasing age of the global population and the higher prevalence of conditions treated with amitriptyline in this age group[3].

By Dosage Form and Route of Administration

Amitriptyline is available in different dosage forms such as tablets, injections, and others, and can be administered via oral or intramuscular routes. These variations cater to different patient needs and preferences[3].

Future Projections

Market Growth

The amitriptyline market is expected to continue growing, driven by increasing regulatory approvals, the rising prevalence of mental health disorders, and the growing demand for antidepressants and pain management treatments. The market is projected to reach US$ 888.8 million by 2030, with a CAGR of 5.6% during the forecast period[2].

Research and Development

The rise in research and development activities and a strong product pipeline are expected to provide beneficial opportunities for the amitriptyline market. New formulations and delivery methods, such as the skin-applied ATX01 cream, could further expand the market[3].

Key Takeaways

• Clinical Trials: Amitriptyline is being investigated in various clinical trials for conditions like erythromelalgia and chronic neuropathic pain.
• Market Size and Growth: The global amitriptyline market was valued at US$ 607.0 million in 2023 and is expected to grow at a CAGR of 5.6% to reach US$ 888.8 million by 2030.
• Drivers: Regulatory approvals, COVID-19 impact, and the rising prevalence of mental health disorders are key drivers of market growth.
• Restraints: Side effects and competition from other treatments are significant restraints.
• Segmentation: The market is segmented by strength, application, demographic, dosage form, and route of administration.

FAQs

What is Amitriptyline used for?

Amitriptyline is used to treat a range of conditions including depressive disorders, neuralgia, chronic neuropathic pain, and migraines.

What are the common side effects of Amitriptyline?

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

How is the COVID-19 pandemic impacting the Amitriptyline market?

The COVID-19 pandemic has had a positive impact on the market due to the increased use of amitriptyline to treat post-COVID-19 symptoms and the rise in mental health disorders.

What is the current market size of Amitriptyline?

The global amitriptyline market was estimated to be valued at US$ 607.0 million in 2023.

What is the projected growth rate of the Amitriptyline market?

The market is expected to exhibit a CAGR of 5.6% during the forecast period from 2023 to 2030.

Sources

1. Patsnap: Amitriptyline Hydrochloride - Drug Targets, Indications, Patents.
2. Coherent Market Insights: Amitriptyline Market Size, Trends and Forecast to 2030.
3. Data Bridge Market Research: Global Amitriptyline Market - Industry Trends and Forecast to 2029.
4. Withpower: Amitriptyline for Erythromelalgia Clinical Trial 2024.
5. Biospace: Neuropathic Pain Market worth $11.53 Billion by 2030, Coherent Market Insights.