US company evaluates Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
Jina Pharmaceuticals Inc in collaboration with Novum Pharmaceutical Research Services , Lambda Therapeutic Research Ltd. and Intas Pharmaceuticals, Ltd. is starting a new clinical trial of Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients.
This study aims to evaluate the efficacy and safety of 8 mg endoxifen in the study population. As endoxifen represents a totally new class of drugs in the treatment of the bipolar disorder, it is essential to compare the drug against placebo to rule out the psychological influence upon study results. More so given the risks to patients and their communities from a medication whose efficacy has not been thoroughly evaluated against a placebo control. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products.
Protein Kinase C (PKC) plays a major role in the regulation of both pre and postsynaptic neurotransmission. Excessive activation of PKC results in symptoms related to bipolar disorder. PKC exists as a family of closely related subspecies, has a heterogeneous distribution in the brain (with particularly high levels in presynaptic nerve terminals), and plays a crucial role in the regulation of neuronal excitability, neurotransmitter release, regulation of synaptic plasticity and various forms of learning and memory. Research findings show that the PKC pathway can be used as a target for developing treatment strategies for bipolar disorder. Endoxifen exhibited activity in inhibiting the PKC activity.
In patients with acute bipolar mania, rapid reduction of symptoms is a key treatment goal; however, there is also a need for effective maintenance of effect treatment beyond the period of acute stabilization. The current study will evaluate the efficacy and safety of Endoxifen in Bipolar I Disorder patients against a control placebo arm.
The clinical trial started on March 23, 2020 and will continue throughout May 31, 2021.
The contacts and locations are the 16420 NW 59 Avenue, Miami, Florida, United States. For more details: https://ichgcp.net/clinical-trials-registry/NCT04315792
