CLINICAL TRIALS PROFILE FOR METHOCARBAMOL

All Clinical Trials for METHOCARBAMOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04464512 ↗	Suboxone User Perioperative Early Referral and Enhanced Recovery After Surgery- Orthopaedic Trauma Surgery Population	Recruiting	West Virginia Clinical and Translational Science Institute	Phase 4	2020-01-10	Suboxone treated patients present a unique challenge to providers during the perioperative period in terms of pain control. If the patient is taken off their prescribed suboxone 48 hours prior to the procedure, the opioid pain medication will function but the patient is exposed to the very medications originally responsible for their substance addiction. The discontinuation of suboxone can potentially lead to opioid addiction relapse in this situation (Anderson et al., 2017). If the patient remains on their suboxone, opioid pain medications can be ineffective or require very large dosages to control pain but the patient's risk of relapse may be lower (Anderson et al., 2017). Classic opioid pain medications prescribed by providers for post-operative pain control such as hydromorphone, morphine and fentanyl have lower affinity for the Mu 1 and 2 receptors when compared to buprenorphine. These medications are less effective or ineffective when given to a patient treated with Suboxone due to their inability to bind to the Mu receptor in the presence of buprenorphine. The only clinically used full agonist opioid with stronger affinity for the MU 1 and 2 receptors is sufentanil. In theory, sufentanil would be able to displace buprenorphine from the receptor and stimulate the receptor as a full agonist leading to predictable pain control. Through the Kappa receptor antagonism, buprenorphine may improve the treatment of opioid-induced hyperalgesia (Koppert W et al., 2005). Additional benefits may include buprenorphine's Kappa receptor antagonism may help in treating forms of depression and depression (Lalanne et al., 2014). At our institution, orthopedic trauma patients have a high incidence of suboxone use and make an ideal study population as they are often otherwise healthy. Our study compares opioid consumption in the perioperative period in patients taking suboxone on presentation to the operating room. The patients will randomized to receive conventional opioid based regimen versus buprenorphine and sufentanil based opioid regimen. The goal of the study is to determine if the combination of buprenorphine and sufentanil based pain control is superior to classic opioid treatment strategies in patients taking suboxone while presenting for orthopedic trauma surgery.
NCT02642874 ↗	Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients	Unknown status	Tanta University	Phase 3	2017-04-01	Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug. Methocarbamol is a central muscle relaxant used to treat skeletal muscle spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide range of safe and effective dosages.
NCT02831569 ↗	Japanese IP-TN Trial	Completed	SSP Co., Ltd.	Phase 3	2016-07-27	This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy of loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated with muscle strain. More than 90 patients will be screened to enroll approximately 80 patients in the trial. After giving written informed consent, patients will be enrolled in the trial. Patients who are considered eligible for the trial by the Investigator after consent and complete the trial procedures and assessments at Visit 1 will receive the trial medication and enter the open-label treatment period of 2 weeks. Patients who complete the open-label treatment period will enter the follow-up period of 1 week and complete the trial after confirmation at the last visit (or phone interview).
NCT02831569 ↗	Japanese IP-TN Trial	Completed	Boehringer Ingelheim	Phase 3	2016-07-27	This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy of loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated with muscle strain. More than 90 patients will be screened to enroll approximately 80 patients in the trial. After giving written informed consent, patients will be enrolled in the trial. Patients who are considered eligible for the trial by the Investigator after consent and complete the trial procedures and assessments at Visit 1 will receive the trial medication and enter the open-label treatment period of 2 weeks. Patients who complete the open-label treatment period will enter the follow-up period of 1 week and complete the trial after confirmation at the last visit (or phone interview).
NCT02665286 ↗	Orphenadrine and Methocarbamol for LBP	Completed	Montefiore Medical Center	Phase 4	2016-03-01	Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone
NCT02432456 ↗	Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients	Completed	Medical College of Wisconsin	Phase 4	2015-09-01	This study will evaluate the effectiveness of ketamine infusions in the management of acute pain resulting from broken ribs suffered following a blunt trauma. Half of patients will receive the institutional standard of care and a placebo infusion (no active medication). The other half of patients will receive the institutional standard of care and a ketamine infusion. All subjects and staff will be blinded as to whether they are receiving placebo or ketamine.

Clinical Trial Conditions for METHOCARBAMOL

Condition Name

Condition Name for METHOCARBAMOL
Intervention	Trials
Low Back Pain	2
Buprenorphine Dependence	1
Post Operative Pain	1
Chronic Pain	1

Condition MeSH

Condition MeSH for METHOCARBAMOL
Intervention	Trials
Fractures, Bone	2
Back Pain	2
Low Back Pain	2
Hernia, Ventral	1

Clinical Trial Locations for METHOCARBAMOL

Trials by Country

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Trials by Country for METHOCARBAMOL
Location	Trials
United States	6
Italy	2
Japan	1
Egypt	1

Trials by US State

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−

Trials by US State for METHOCARBAMOL
Location	Trials
Texas	1
Illinois	1
Minnesota	1
West Virginia	1
New York	1

Clinical Trial Progress for METHOCARBAMOL

Clinical Trial Phase

Clinical Trial Phase for METHOCARBAMOL
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	3
N/A	1

Clinical Trial Status

Clinical Trial Status for METHOCARBAMOL
Clinical Trial Phase	Trials
Not yet recruiting	3
Recruiting	3
Completed	3

Clinical Trial Sponsors for METHOCARBAMOL

Sponsor Name

Sponsor Name for METHOCARBAMOL
Sponsor	Trials
Hippocrates Research	1
Aziende Chimiche Riunite Angelini Francesco S.p.A	1
Medical College of Wisconsin	1

Sponsor Type

Sponsor Type for METHOCARBAMOL
Sponsor	Trials
Other	11
Industry	3

Methocarbamol: Clinical Trials, Market Analysis, and Projections

Introduction

Methocarbamol is a skeletal muscle relaxant commonly used to alleviate discomfort associated with acute, painful musculoskeletal conditions. This article delves into the recent clinical trials, market analysis, and future projections for methocarbamol, providing a comprehensive overview of its efficacy, market trends, and potential growth.

Clinical Trials and Efficacy

Acute Low Back Pain (ALBP)

Recent clinical trials have evaluated the efficacy of methocarbamol in treating acute low back pain. A systematic review published in 2024 analyzed three studies involving 405 ALBP patients, with 163 receiving methocarbamol. The results indicated that methocarbamol showed potential for improving pain outcomes at one week when combined with NSAIDs like Indomethacin or Naproxen. However, it was less effective than diazepam in the short-term management of pain, particularly at 30 and 60 minutes post-administration[1].

Another study conducted in Iran compared the efficacy of intravenous methocarbamol and diazepam in patients with acute low back pain. While both drugs reduced pain scores after 60 minutes, diazepam was slightly more effective but associated with a higher risk of drowsiness[4].

Mechanism of Action

Methocarbamol's mechanism of action is not fully understood but is believed to involve central nervous system depressant activity. It blocks spinal polysynaptic reflexes, decreases nerve transmission in spinal and supraspinal pathways, and prolongs the refractory period of muscle cells. This action does not affect muscle fiber contraction, motor end plates, or nerve fibers[5].

Market Analysis

Global Muscle Relaxant Market

The global muscle relaxant market is expected to grow significantly due to the increasing prevalence of musculoskeletal conditions and lower back pain. By 2037, the market is projected to reach USD 8.06 million, growing at a CAGR of 6.9% from 2025 to 2037. The neuromuscular blockers segment is anticipated to garner the largest revenue, driven by the growing number of patients with neuromuscular disorders[2].

Methocarbamol Tablets Market

The methocarbamol tablets market was valued at USD 1.2 billion in 2023 and is expected to reach USD 1.9 billion by 2031, growing at a CAGR of 5.8% from 2024 to 2031. This growth is driven by the rising incidence of musculoskeletal injuries and disorders, particularly among the elderly and active populations. The market expansion is also supported by the increasing availability of generic methocarbamol tablets and advancements in pharmaceutical production[3].

Market Segments and Trends

Application Segments

Methocarbamol tablets are categorized based on their applications, including muscle relaxation, pain relief, spasm treatment, back pain, and musculoskeletal disorders. The demand for methocarbamol is boosted by its efficacy in treating these conditions, especially in the context of rising sports-related injuries and an aging population[3].

Product Segments

The market is segmented by product type, including oral tablets, extended-release tablets, generic methocarbamol, combination tablets, and powder formulations. The availability of various formulations enhances treatment accessibility and contributes to market growth[3].

Geographical Segments

The methocarbamol market is analyzed across geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region's market size and growth prospects are influenced by local healthcare policies, population demographics, and the prevalence of musculoskeletal conditions[3].

Growth Drivers and Challenges

Growth Drivers

• Increasing Prevalence of Musculoskeletal Conditions: The global rise in musculoskeletal disorders, including lower back pain, muscle spasms, and other related conditions, drives the demand for methocarbamol.
• Aging Population: The aging population is more vulnerable to musculoskeletal issues, contributing to the growing need for muscle relaxants like methocarbamol.
• Advancements in Pharmaceutical Production: Improvements in pharmaceutical production, including the development of generic formulations, enhance treatment accessibility and affordability[2][3].

Challenges

• Limited Clinical Evidence: Despite its widespread use, there is a need for more rigorous prospective controlled studies to fully understand the efficacy and long-term effects of methocarbamol, especially when combined with other medications[1].
• Adverse Effects: Common adverse effects such as nausea and drowsiness, particularly when compared to other muscle relaxants like diazepam, can impact patient compliance and satisfaction[1][4].

Future Projections

Market Expansion

The methocarbamol market is expected to continue growing due to the increasing demand for effective muscle relaxants. The focus on research and development to improve therapeutic efficacy and reduce adverse effects will further accelerate market expansion[3].

Clinical Research

Future clinical trials should address the limitations of current studies by including larger sample sizes and control groups to better understand the specific implications of methocarbamol in various treatment scenarios. This will lead to a more comprehensive approach to its use in clinical settings[1].

Key Takeaways

• Efficacy in ALBP: Methocarbamol shows potential in improving pain outcomes for acute low back pain patients, especially when combined with NSAIDs.
• Market Growth: The global methocarbamol market is projected to grow significantly, driven by the increasing prevalence of musculoskeletal conditions and advancements in pharmaceutical production.
• Growth Drivers: The aging population, rising sports-related injuries, and improvements in generic formulations are key drivers of market growth.
• Challenges: There is a need for more rigorous clinical trials to fully understand the efficacy and long-term effects of methocarbamol.

FAQs

What is the primary use of methocarbamol?

Methocarbamol is primarily used as a skeletal muscle relaxant to alleviate discomfort associated with acute, painful musculoskeletal conditions.

How effective is methocarbamol in treating acute low back pain?

Methocarbamol shows potential in improving pain outcomes for acute low back pain patients, especially when combined with NSAIDs, although it may be less effective than diazepam in the short term.

What are the common adverse effects of methocarbamol?

Common adverse effects include nausea and drowsiness, with the latter being more pronounced when compared to other muscle relaxants like diazepam.

What drives the growth of the methocarbamol market?

The growth is driven by the increasing prevalence of musculoskeletal conditions, an aging population, and advancements in pharmaceutical production, including the availability of generic formulations.

What are the future projections for the methocarbamol market?

The market is expected to continue growing, with a projected value of USD 1.9 billion by 2031, driven by increasing demand and ongoing research to improve therapeutic efficacy.

Sources

1. Bahria Wided, Makhlouf Yasmine: "Effect of Methocarbamol on acute low back pain: A systematic review." F1000Research, 2024.
2. ResearchNester: "Muscle Relaxant Drugs Market Size & Share, Growth Forecasts 2037." ResearchNester, 2024.
3. MarketResearchIntellect: "Methocarbamol Tablets Market Size, Trends and Forecast." MarketResearchIntellect, 2024.
4. PubMed: "Methocarbamol versus diazepam in acute low back pain." PubMed, 2023.
5. DrugBank: "Methocarbamol: Uses, Interactions, Mechanism of Action." DrugBank.