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Clinical Trial News

Psilocybin Shows Similar Efficacy to Escitalopram in Depression: Phase 2 Trial Follow-up

  • A 6-month follow-up of a phase 2 trial reveals that psilocybin shows similar effectiveness to escitalopram in treating moderate-to-severe major depressive disorder.
  • The study highlights the potential of psilocybin therapy as an alternative treatment paradigm for depression, warranting further investigation.
  • Researchers emphasize the need for varied treatment approaches due to the diverse nature of depression among individuals.
  • The findings are encouraging, especially alongside larger ongoing trials of psilocybin in the UK, Europe, and the US.

Relacorilant and Surgery Improve Hemostatic Markers in Cushing's Syndrome

  • A study shows that hypercoagulopathy, a complication in Cushing's Syndrome (CS), improves with both relacorilant treatment and surgery.
  • Relacorilant, a selective glucocorticoid receptor modulator (SGRM), demonstrated improvements in coagulation markers after 3-4 months of treatment.
  • Surgical intervention also led to improvements in coagulation markers within an average of 6 months post-operation in CS patients.
  • The study suggests relacorilant may offer a beneficial treatment option for CS patients, particularly those at high risk of VTE or not suitable for surgery.

Study to Evaluate CORT125134 in Participants With Cushing's Syndrome

NCT02804750CompletedPhase 2
Corcept Therapeutics
Posted 6/1/2016

A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas

NCT04308590CompletedPhase 3
Corcept Therapeutics
Posted 7/27/2020

Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

NCT03604198Active, Not RecruitingPhase 2
Corcept Therapeutics
Posted 5/7/2018

Atezolizumab and Durvalumab Combination Therapies Not Cost-Effective for ED-SCLC in Japan

  • A cost-effectiveness analysis in Japan reveals that atezolizumab and durvalumab, when combined with chemotherapy, are not cost-effective as first-line treatments for extensive-disease small-cell lung cancer (ED-SCLC).
  • The incremental cost-effectiveness ratios (ICERs) for atezolizumab and durvalumab combination therapies significantly exceeded the willingness-to-pay threshold of 15 million JPY per quality-adjusted life year (QALY).
  • Sensitivity analyses suggest that substantial price reductions for atezolizumab and durvalumab would be necessary to achieve cost-effectiveness, but such reductions are unlikely to be feasible.
  • The findings align with previous studies in the USA and China, indicating consistent economic challenges associated with immune checkpoint inhibitor combination treatments for ED-SCLC.

End-of-Dose Phenomena Observed in Multiple Sclerosis Patients on Ofatumumab

  • A study of 103 MS patients found that 34% experienced end-of-dose phenomena (EOD) with ofatumumab, impacting their quality of life.
  • EOD was associated with higher baseline disability, longer disease duration, and older age, highlighting the need for careful monitoring.
  • Fatigue, cognitive impairment, and gait difficulties were the most commonly reported EOD symptoms among patients on ofatumumab.
  • Compared to ocrelizumab, ofatumumab showed a lower incidence of the wearing-off effect in a separate study, suggesting potential differences in B-cell depletion.

A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants

NCT05701423Active, Not Recruiting
Biogen
Posted 2/8/2023

Psilocybin Shows Promise as Alternative to SSRIs for Depression Treatment

  • A recent study indicates that psilocybin, the active compound in magic mushrooms, offers comparable long-term benefits to escitalopram for treating depression.
  • Psilocybin outperformed escitalopram in enhancing psychosocial functioning, including a greater sense of meaning in life and improved social connectedness.
  • Researchers emphasize that psilocybin is still experimental and should only be administered in controlled environments due to potential risks.
  • Experts caution that not everyone is a candidate for psilocybin treatment, particularly those with a history of psychosis or bipolar disorder.

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

NCT03775200CompletedPhase 2
COMPASS Pathways
Posted 3/1/2019

Psilocybin for the Treatment of Cluster Headache

NCT02981173CompletedPhase 1
Yale University
Posted 12/5/2016

PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder

NCT04353921Terminated
Usona Institute
Posted 6/30/2020

Ozanimod Shows Sustained Reduction in Brain Atrophy in Relapsing Multiple Sclerosis

  • Long-term data from the DAYBREAK trial shows ozanimod treatment resulted in sustained reductions in brain volume loss (BVL) for up to 5 years in relapsing MS patients.
  • Patients on continuous ozanimod demonstrated stable and low rates of whole brain volume loss compared to those who switched from interferon-beta-1a.
  • Switching to ozanimod from interferon-beta-1a reduced rates of whole brain volume loss and reversed cortical grey matter volume loss trends.
  • After 72 months, ozanimod treatment showed a low adjusted annualized relapse rate, with a majority of patients remaining relapse-free.

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

NCT02576717CompletedPhase 3
Celgene
Posted 10/16/2015

Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

NCT02294058CompletedPhase 3
Celgene
Posted 12/3/2014

Stealth BioTherapeutics Presents Preclinical Data on Bevemipretide for AMD

  • Stealth BioTherapeutics presented preclinical data demonstrating bevemipretide's effective retinal delivery via topical ocular administration in age-related macular degeneration (AMD) models.
  • The study showed bevemipretide's protective effects, including mitigating retinal thickness reduction in rats exposed to bright light-induced retinal degeneration.
  • Bevemipretide improved the viability of iPSC-derived retinal pigment epithelial (RPE) cells from AMD patients and reduced mitochondrial reactive oxygen species (ROS) production.
  • Stealth BioTherapeutics plans to initiate clinical studies to further develop topical bevemipretide as a potential disease-modifying therapy for dry AMD.

ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

NCT06373731RecruitingPhase 3
Stealth BioTherapeutics Inc.
Posted 5/30/2024

Whole-Pelvis Radiation Improves Survival in Muscle-Invasive Bladder Cancer

  • A retrospective study of 809 patients with muscle-invasive bladder cancer found that whole-pelvis radiation therapy improved cancer-specific and overall survival.
  • Patients receiving whole-pelvis radiation were more likely to have node-positive disease and receive neoadjuvant or concurrent chemotherapy.
  • Multivariable analysis showed whole-pelvis radiation therapy was associated with improved cancer-specific survival (HR 0.66, p = 0.016) and overall survival (HR 0.68, p = 0.002).
  • The findings suggest pelvic lymph node irradiation may improve survival, but prospective validation is needed to confirm these results.

Phase 3 Gliofocus Trial Aims to Improve Outcomes in MGMT Unmethylated Glioblastoma with Niraparib

• The phase 3 Gliofocus trial (NCT06388733) is evaluating niraparib versus temozolomide in newly diagnosed MGMT unmethylated glioblastoma patients. • Preliminary data from a phase 0/2 trial showed a median overall survival of 20.3 months with niraparib plus radiotherapy, with favorable drug concentrations in brain tissue. • The Gliofocus trial aims to establish a clinically relevant overall survival benchmark of 18 months, improving both survival and quality of life for patients. • Researchers at the Ivy Brain Tumor Center are expediting clinical trial processes to bring new treatments to glioblastoma patients more efficiently.

Trial of Niraparib in Participants with Newly-diagnosed Glioblastoma and Recurrent Glioma

NCT05076513Active, Not RecruitingEarly Phase 1
Nader Sanai
Posted 10/29/2021

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

NCT06388733RecruitingPhase 3
Ivy Brain Tumor Center
Posted 6/19/2024

GPRC5D-Targeted Therapy Shows Promise in Multiple Myeloma Treatment

  • GPRC5D has emerged as a crucial target in multiple myeloma, offering new therapeutic avenues, especially before or as a bridge to BCMA-targeted therapies.
  • Talquetamab, a GPRC5D-directed therapy, has demonstrated efficacy in clinical trials like MonumenTAL-1 and MonumenTAL-3, showing potential in combination therapies.
  • Common toxicities associated with talquetamab, such as oral and skin-related issues, are generally manageable through dose adjustments and are less severe than those of bispecific antibodies.
  • GPRC5D-targeted treatments exhibit a reduced risk of infectious toxicity and have not been linked to significant cardiac, pulmonary, renal, or neuropathy-related adverse effects.

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma

NCT04555551Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 9/8/2020

Safety and Efficacy of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM

NCT05739188RecruitingPhase 1
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Posted 2/7/2023

A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

NCT05455320Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/13/2022

A Study of CAR-T Cells Targeting GPRC5D in the Treatment of r/r Multiple Myeloma

NCT05016778Active, Not RecruitingEarly Phase 1
Zhejiang University
Posted 6/8/2021

Study of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases

NCT05647512WithdrawnPhase 1
LaNova Medicines Limited
Posted 1/18/2023

A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)

NCT04557150Active, Not RecruitingPhase 1
Hoffmann-La Roche
Posted 11/11/2020

A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma

NCT04674813Active, Not RecruitingPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 2/24/2021

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04634552RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/1/2021

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