Opalmon (limaprost) / Meiji Seika, Ono Pharmaceutical, Sumitomo Pharma, Sino Biopharm - LARVOL DELTA

The Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis (clinicaltrials.gov) - P=N/A | N=107 | Completed | Sponsor: Dong-A ST Co., Ltd. | Recruiting ➔ Completed

Trial completion • Musculoskeletal Diseases • Orthopedics

A Prospective, Observational Study of Limaprost Tablets in the Treatment of Degenerative Lumbar Spinal Stenosis (ChiCTR) - P=N/A | N=1200 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University o

New trial • Musculoskeletal Diseases • Orthopedics

The Effect of Comprehensive and Integrative Medical Services on Patients with Degenerative Lumbar Spinal Stenosis: A Randomized Controlled Study. (PubMed, Medicina (Kaunas)) - "All participants received SNRB plus pharmacotherapy (limaprost, pregabalin). In DLSS patients receiving SNRB and pharmacotherapy, adjunctive CIMS resulted in greater pain reduction over 12 weeks compared with standard care alone, without introducing new safety concerns. These findings support the clinical utility of CIMS as an effective adjunctive treatment option for DLSS."

Journal • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain

Use of pregabalin and limaprost in the conservative treatment of lumbar spinal stenosis: a systematic review of the current evidence. (PubMed, Eur J Clin Pharmacol) - "No agent demonstrated clear superiority in the treatment of LSS, though both pregabalin and limaprost showed significant within-group benefits. Pregabalin's greater side effect profile and cost may support preferential use of limaprost in LSS patients. Nevertheless, due to limited comparative trials and substantial heterogeneity in interventions and outcome measures, further high-quality studies are needed to elucidate this non-inferiority and inform clinical guidelines."

Journal • Review • Gastrointestinal Disorder • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain

Efficacy of JOINS Tablet for Lumbar Spinal Stenosis: Prospective, Randomized, Open-Label Clinical Trial. (PubMed, Medicina (Kaunas)) - "The control group was prescribed the usual spinal stenosis medications (Naproxen, Limaprost, and Pregabalin), while the test group was prescribed JOINS tablets in addition to the usual medications...At all follow-up periods, the functional outcomes did not show statistically significant differences between the test and control groups. The significant reduction in pain suggests that JOINS tablets may be an effective adjunct for pain relief, particularly in patients at high risk of adverse effects from long-term NSAID use."

Clinical • Journal • Back Pain • Inflammation • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain

The Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis (clinicaltrials.gov) - P=N/A | N=116 | Recruiting | Sponsor: Dong-A ST Co., Ltd. | N=243 ➔ 116 | Trial completion date: Oct 2025 ➔ Feb 2026 | Trial primary completion date: Aug 2025 ➔ Feb 2026

Enrollment change • Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Orthopedics

Letter to the Editor Regarding "Comparative Study on the Efficacy of Pregabalin Versus Limaprost in Patients With Lumbar Spinal Stenosis: A Prospective, Randomized Controlled Trial". (PubMed, World Neurosurg) - No abstract available

Journal • Musculoskeletal Diseases • Orthopedics

The Patient-Reported Outcomes of Postoperative Prostaglandin E1 Derivative in Lumbar Spine Surgery: A Randomized, Double-Blind, Controlled Trial. (PubMed, Global Spine J) - "No clinically significant differences were observed between groups for other patient-reported outcomes.ConclusionPostoperative limaprost did not result in a significant reduction in leg numbness compared to placebo. Nevertheless, limaprost may offer potential benefits in alleviating back pain following decompressive and fusion lumbar spine surgery."

Clinical • Journal • Back Pain • Musculoskeletal Pain • Orthopedics • Pain

Conservative and newer drug treatment for degenerative cervical myelopathy. (PubMed, J Clin Orthop Trauma) - "Riluzole did not replicate its promising animal results in human trials, using the modified Japanese Orthopaedic Association (mJOA) score as an outcome measure. Cerebrolysin is promising but needs more RCTs to define its role in the management algorithm. Limaprost Alfadex provided inconclusive evidence, however, is in an ongoing phase III trial...Anti-Fas ligand antibody has not been studied in humans but demonstrated benefit in animal models. Research should focus on large-scale RCTs for these drugs with careful attention to long-term effects, side effects, and finding the most effective doses."

Journal • CNS Disorders • Infectious Disease • Inflammation • Orthopedics • FASLG

A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Limaprost Tablets for Patients with Residual Paresthesia after Lumbar Fusion Surgery for Degenerative Lumbar Spinal Stenosis (ChiCTR) - P4 | N=200 | Recruiting | Sponsor: The Third Affiliated Hospital of Southern Medical University; The Third Affiliated Hospital of Southern Medical University

New P4 trial • Musculoskeletal Diseases • Orthopedics

The Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis (clinicaltrials.gov) - P=N/A | N=243 | Recruiting | Sponsor: Dong-A ST Co., Ltd.

New trial • Musculoskeletal Diseases • Orthopedics

Pharmacological Treatment of Degenerative Cervical Myelopathy: A Critical Review of Current Evidence. (PubMed, Neurospine) - "Riluzole exhibits effectiveness solely in rat models, but not in treating mild DCM in humans. Cerebrolysin emerges as a potential neuroprotective agent for myelopathy in animals but had contradictory results in clinical trials...Cilostazol, anti-Fas ligand antibody, and Jingshu Keli display promise in animal studies, while erythropoietin, granulocyte colony-stimulating factor and limaprost alfadex exhibit potential in both animal and human research...Current pharmacological efforts target ion channels, stem cell differentiation, inflammatory, vascular, and apoptotic pathways. The inherent nature and pathogenesis of DCM offer substantial prospects for developing neurodegenerative or neuroprotective therapies capable of altering disease progression, potentially delaying surgical intervention, and optimizing outcomes for those undergoing surgical decompression."

Journal • Review • CNS Disorders • FASLG

Overcoming the challenge of potent endogenous interferences in limaprost quantification: An innovative methodology combining differential mobility spectrometry with LC-MS/MS for ultra-high sensitivity, selectivity and significantly enhanced throughput. (PubMed, Talanta) - "This integration yields a method that is currently the most sensitive and features the shortest analytical time, making it the sole technique capable of meeting the requirements for limaprost pharmacokinetic and bioequivalence investigations. This method demonstrates robustness and is successfully employed in a pharmacokinetic investigation of limaprost in human subjects, underscoring that the combination of DMS with LC-MS/MS serves as an efficacious strategy for overcoming the challenges inherent in analyzing biological samples afflicted by multiple interferences."

Journal

Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection (clinicaltrials.gov) - P=N/A | N=104 | Recruiting | Sponsor: Seoul National University | Trial completion date: Aug 2023 ➔ Aug 2025 | Trial primary completion date: Jun 2023 ➔ Jun 2025

Combination therapy • Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Orthopedics

Comparative study on the efficacy of pregabalin versus limaprost in patients with lumbar spinal stenosis: A prospective, randomized controlled trial. (PubMed, World Neurosurg) - "Efficacy of pregabalin, limaprost in back and leg pain, ODI, EQ-5D, and sleep quality, but there was no significant difference between the two groups. Thus, it is advisable to prescribe based on individual drug responses and potential complications."

Journal • Back Pain • CNS Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Sleep Disorder

Limaprost and the Risk of Bleeding: A Self-Controlled Case Series Study. (PubMed, Neurospine) - "Our findings suggest that the risk of bleeding increased by 1.5-fold in periods of limaprost exposure compared to unexposed periods, with particularly higher risks observed during the first week after limaprost initiation, with concomitant drugs related to bleeding, and with a higher daily dose. A careful risk-benefit assessment is warranted when initiating limaprost, especially when administered with other medications or in higher daily doses."

Journal • Musculoskeletal Diseases • Orthopedics

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Nephrology • Urology

The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy (clinicaltrials.gov) - P3 | N=160 | Completed | Sponsor: Seoul National University Hospital | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Apr 2023

Surgery • Trial completion • Trial completion date

Clinical Efficacy of Neurotropin for Lumbar Spinal Stenosis with Low Back Pain. (PubMed, Pain Ther) - "Combined use of Neurotropin and limaprost showed an additional effect on walking speed compared with single drug administration. Neurotropin may contribute to the improvement of low back pain, walking speed/stride length, and standing balance."

Journal • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain

Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection (clinicaltrials.gov) - P=N/A | N=104 | Recruiting | Sponsor: Seoul National University | Trial completion date: Aug 2022 ➔ Aug 2023 | Trial primary completion date: May 2022 ➔ Jun 2023

Combination therapy • Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Orthopedics

Clinical Effectiveness of Conservative Treatments on Lumbar Spinal Stenosis: A Network Meta-Analysis. (PubMed, Front Pharmacol) - " Among the commonly used conservative treatments for the treatment of lumbar spinal stenosis, limaprost may have better efficacy in improving the Japanese Orthopaedic Association Score and decreasing the Oswestry Dysfunction Index, with a beneficial effect on decreasing the visual analog scale and improving the EuroQol Five Dimensions Questionnaire. Systematic Review Registration: website, identifier registration number."

Clinical • Retrospective data • Review • Musculoskeletal Diseases • Orthopedics • Pain

The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Seoul National University Hospital | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date

Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection (clinicaltrials.gov) - P=N/A | N=104 | Recruiting | Sponsor: Seoul National University | Not yet recruiting ➔ Recruiting | Initiation date: May 2021 ➔ Nov 2021

Combination therapy • Enrollment open • Trial initiation date • Musculoskeletal Diseases • Orthopedics

A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain. (PubMed, Aten Primaria) - "This SR provides clear evidence for lack of effectiveness of pregabalin and gabapentin for sciatica pain management. In view of this, its routine clinical use cannot be supported."

Adverse events • Journal • Retrospective data • Review • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain • Peripheral Neuropathic Pain

Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection (clinicaltrials.gov) - P=N/A; N=104; Not yet recruiting; Sponsor: Seoul National University

Clinical • Combination therapy • New trial • Musculoskeletal Diseases • Orthopedics