- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Clinical, Clinical protocol, P3 data, Journal, HEOR: Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost-utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study). (Pubmed Central) - Mar 23, 2022
P4
The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and community engagement activities. NCT04739995.
- |||||||||| Enrollment open: Psychobiological Mechanisms Underlying Chronic Pain (clinicaltrials.gov) - Feb 23, 2022
P=N/A, N=100, Recruiting,
LDN has no effect on QOL and fatigue in HGG patients during concurrent chemotherapy and radiation therapy. Not yet recruiting --> Recruiting
- |||||||||| Vimpat (lacosamide) / UCB, Daiichi Sankyo, Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Review, Journal: Topical Therapeutic Options in Corneal Neuropathic Pain. (Pubmed Central) - Feb 19, 2022
Newer therapies, including topical lacosamide and low-dose naltrexone are emerging therapeutic options that may also be considered. Summary: Corneal neuropathic pain with a significant peripheral component may be managed with a variety of topical therapeutic options.
- |||||||||| naltrexone / Generic mfg.
Journal: Naltrexone a potential therapeutic candidate for COVID-19. (Pubmed Central) - Feb 3, 2022
Clinical toxicity measurements may not be required for LDN since naltrexone was previously tested and is an approved drug by the FDA. Communicated by Ramaswamy H. Sarma.
- |||||||||| Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
EFFICACY OF LOW DOSE NALTREXONE IN PATIENTS WITH CROHN’S COLITIS AND ILEITIS () - Jan 28, 2022 - Abstract #CCCongress2022CCCongress_373;
Rectal images before starting LDN for CD (A) and 3 years of maintenance therapy with LDN (B) Figure 2. Ileal ulcers seen after the second surgery (A) and scar tissue seen at the ulcer sites at the time the patient with on infliximab, methotrexate, and LDN (B)
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Trial completion date, Trial primary completion date: LoDoNaVasc: Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (clinicaltrials.gov) - Jan 27, 2022
P2, N=36, Recruiting,
Ileal ulcers seen after the second surgery (A) and scar tissue seen at the ulcer sites at the time the patient with on infliximab, methotrexate, and LDN (B) Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Trial completion date, Trial primary completion date: Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy (clinicaltrials.gov) - Jan 19, 2022
P2, N=35, Recruiting,
Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 Trial completion date: Sep 2021 --> Sep 2023 | Trial primary completion date: Sep 2021 --> Sep 2023
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Clinical, Journal: Effect of Low-Dose Naltrexone on Egyptian Children with Intractable Epilepsy: A Case Series Study. (Pubmed Central) - Jan 11, 2022
Low-dose naltrexone (LDN) has been proposed as an immune modulator in multiple diseases and proved benefit especially in diseases with immune dysregulation. The purpose of this study is to demonstrate the effect of LDN in the treatment of children with intractable epilepsy and discuss its potential role in epileptogenesis process.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Clinical, Journal: What Do Primary Care Providers and Nurses Need to Know About Managing Chronic Pain? (Pubmed Central) - Nov 29, 2021
The case study outlines the success a patient found using alternative options other than opioid medication with lifestyle changes and a newer medication called low-dose Naltrexone (LDN). The purpose of this case study is to present a patient who has found success in managing chronic pain through alternative treatments and help the provider be able to educate patients on the importance of lifestyle changes to increase the prescribing and compliance of alternative treatment options.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Clinical, Review, Journal: Low-Dose Naltrexone Use for Patients with Chronic Regional Pain Syndrome: A Systematic Literature Review. (Pubmed Central) - Nov 29, 2021
The purpose of this case study is to present a patient who has found success in managing chronic pain through alternative treatments and help the provider be able to educate patients on the importance of lifestyle changes to increase the prescribing and compliance of alternative treatment options. There is a need for additional prospective and interventional studies addressing the use of low-dose naltrexone in the treatment of complex regional pain syndrome symptoms.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Journal: Prurigo excoriée treated with low dose naltrexone. (Pubmed Central) - Nov 29, 2021
She was commenced on low dose naltrexone (LDN), 3 mg nocte, and she became itch free within a few weeks. She reports that the LDN has had a beneficial impact on her quality of life.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Cytocom
Journal: Darier and Hailey-Hailey disease: update 2021. (Pubmed Central) - Nov 12, 2021
Of the systemic medications available for Darier disease, acitretin, which is approved for this purpose, has the best supporting evidence...Low-dose naltrexone produces more satisfactory results in Hailey-Hailey than Darier disease. The present CME article summarizes current knowledge of the two dermatoses, taking recent developments into account.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Cytocom
Review, Journal: Psychopharmacologic Therapies for Irritable Bowel Syndrome. (Pubmed Central) - Nov 6, 2021
The first-line (tricyclic antidepressants, serotonin noradrenaline reuptake inhibitors, selective serotonin reuptake inhibitors) and second-line (atypical antipsychotics, delta-ligand agents, low-dose naltrexone) neuromodulator treatment options are recommended when IBS-associated abdominal pain is of moderate or severe intensity and is persistent. To understand the implementation strategy, the multidimensional clinical profile as a template is used for presenting 3 case scenarios involving painful IBS and DGBI of varying complexity.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Cytocom
Preclinical, Journal: [Met]-enkephalin preserves diffusion metrics in EAE mice. (Pubmed Central) - Oct 28, 2021
Saline treated EAE mice had more demyelination and fewer oligodendrocytes than normal mice. Collectively, these data suggest that a panel of biomarkers including imaging, serum biomarker levels, and behavior correlate with progression of disease, and may begin to validate use of specific non-invasive markers for MS.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Cytocom
Review, Journal: Low-Dose Naltrexone Co-Treatment in the Prevention of Opioid-Induced Hyperalgesia. (Pubmed Central) - Oct 15, 2021
Additionally, it seeks to characterize the underlying mechanisms that enable opioid antagonist naltrexone to reduce OIH while still allowing opioids to act as an analgesic. The authors find that OIH is a prevalent condition, and in order to effectively combat it, clinicians and patients can benefit from an extended study on how naltrexone can be utilized as a treatment alongside opioids prescribed for pain management.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Trial completion date, Trial primary completion date: Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome (clinicaltrials.gov) - Oct 5, 2021
P2, N=60, Recruiting,
The authors find that OIH is a prevalent condition, and in order to effectively combat it, clinicians and patients can benefit from an extended study on how naltrexone can be utilized as a treatment alongside opioids prescribed for pain management. Trial completion date: Oct 2021 --> Mar 2022 | Trial primary completion date: Aug 2021 --> Mar 2022
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Trial completion date, Trial initiation date, Trial primary completion date, HEOR: INNOVA: Cost-utility and Physiological Effects of LDN in Patients With Fibromyalgia (clinicaltrials.gov) - Sep 27, 2021
P4, N=120, Not yet recruiting,
Trial completion date: Oct 2021 --> Mar 2022 | Trial primary completion date: Aug 2021 --> Mar 2022 Trial completion date: Dec 2024 --> Jul 2024 | Initiation date: Jul 2021 --> Nov 2021 | Trial primary completion date: Dec 2023 --> Jul 2023
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Trial completion date, Trial primary completion date: Low-dose Naltrexone for Bladder Pain Syndrome (clinicaltrials.gov) - Sep 23, 2021
P2, N=40, Recruiting,
Recruiting --> Active, not recruiting Trial completion date: Feb 2022 --> Feb 2023 | Trial primary completion date: Aug 2021 --> Aug 2022
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Cytocom
[VIRTUAL] 8M404: Alternative Therapies for the Management of Pain Syndromes (Room 6) - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_2651;
They will include up-to-date information about CBD's legal status in the U.S., guidance for counseling of patients regarding available CBD products, cautions about product quality, drug-drug interactions and suggested dosing. Learning Objectives: Review the scientific basis and current clinical evidence for the effects of cannabadiol in rheumatic diseases Discuss available products, safety and suggested dosing of cannabadiol and other alternative products for the treatment of pain syndromes Appraise additional alternative therapies available to treat pain syndromes, including low dose naltrexone, acupuncture and meditation
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Enrollment open: IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone (clinicaltrials.gov) - Sep 20, 2021
P4, N=44, Recruiting,
Learning Objectives: Review the scientific basis and current clinical evidence for the effects of cannabadiol in rheumatic diseases Discuss available products, safety and suggested dosing of cannabadiol and other alternative products for the treatment of pain syndromes Appraise additional alternative therapies available to treat pain syndromes, including low dose naltrexone, acupuncture and meditation Not yet recruiting --> Recruiting
- |||||||||| naltrexone / Generic mfg.
Journal, IO biomarker: Immunometabolic Modulatory Role of Naltrexone in BV-2 Microglia Cells. (Pubmed Central) - Sep 17, 2021
Not yet recruiting --> Recruiting By modulating the phenotypic features by metabolic switching of activated microglia, naltrexone was found to be an effective and powerful tool for immunometabolic reprogramming and could be a promising novel treatment for various neuroinflammatory conditions.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Cytocom
PHM-15 - How Low Can You Go? The Low-Down on Low Dose Analgesics (Gracia 1 / L3) - Sep 15, 2021 - Abstract #PAINWeek2021PAINWeek_232;
Three experienced clinicians will present rationale, evidence, and best practices on the use of these low-dose strategies. Learning Objectives: Summarize the rationale for microdosing as a strategy for initiation of buprenorphine Discuss low-dose methadone as an adjuvant analgesic for refractory pain management Describe the use of low-dose naltrexone as an alternative treatment for chronic pain Using a patient case, explain principles of unique low-dose management strategies
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