Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar I Disorder

In brief

The present 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.

Key facts

Study ID: NCT04315792
Run by: Jina Pharmaceuticals Inc.
People needed: 124
Starts: 2020-08-03
Expected to finish: 2021-08-25
Last updated by the study team: 2024-09-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female patients, 18 to 65 (both inclusive) years of age willing to give written informed consent along with at least one first degree relative (the legally acceptable representative [LAR]) to participate in the study before initiating any study related procedures.
Patients must have a diagnosis of bipolar I disorder and currently display an acute manic episodes with or without mixed features according to DSM-5 criteria as judged by the Investigator.
Young Mania Rating Scale (YMRS) total score of > 20 and ≥4 on two of four core items (irritability, speech, content, disruptive/aggressive behavior) at screening and at randomization (baseline).
Score of >4 in Severity of illness criteria of Clinical Global Impressions- bipolar disorder (CGI-BP) Scale for overall illness at screening and at randomization (baseline).
Ready for voluntary hospitalization (along with the accompanying LAR if required and as advised by the Investigator) for the current manic episode 2 days prior to randomization up to 21 days of in-patient treatment period.
Last intake of the medication(s) for BPD should be 2-7 days prior to randomization depending upon the individual drug's plasma half-life.
Patient and / or LAR understand and agree to comply with all the study requirements.
Male patients of child begetting potential must be practicing adequate contraception.
Females of reproductive potential (which include girls who have entered puberty and all women who have a uterus and ovaries and have not completed menopause), must use anacceptable and effective method of avoiding pregnancy, starting at least four weeks before the first dose of study drug and continuing until at least one month after the last dose of study drug.
Subjects judged clinically not to be at serious suicide risk.

You may not qualify if…

Newly diagnosed patients and not having any suitable treatment exposure in the past for their bipolar mood disorder.
> 20% improvement in YMRS total scores between screening and randomization visits.
Patients who meet DSM-5 criteria for any psychiatric disorder other than Bipolar I Disorder with Acute Mania Episode with or without mixed features.
Patients with seizure disorder.
Obsessive compulsive disorder or any other co-morbid Axis I anxiety disorder
Patients with borderline or anti-social personality disorder of sufficient current severity to interfere with conduct of the study
Patients with classical premenopausal symptoms found at risk of developing intolerable hot flushes, irregular vaginal bleeding.
Use of the following medications:
Antihypertensive agents if stable dose has not been administered for at least 1 month before randomization
Antidepressants in the week (or a period of 5 half-lives of the drug) prior to randomization
Continuous daily or standing orders use of benzodiazepines during the month preceding screening (approximately 5 weeks prior to screening)
Potent cytochrome P450 (CYP) inducers and CYP2D6/CYP3A4 inhibitors 14 days prior to randomization
Depot antipsychotic medications within 1 dosing interval prior to randomization
Use of systemic estrogens 6 weeks prior to randomization
Patients currently on carbapenem agents
Any of the following laboratory abnormalities
Serum bilirubin ≥ 1.5 times ULN
Serum AST/ALT ≥ 2.5 times ULN
Serum TSH >10% above the ULN, regardless of treatment for hypothyroidism or hyperthyroidism
Serum triglyceride level > 2.5 times ULN
Patients with the following cardiac conditions are excluded:
Recent myocardial infarction (<12 months)
QTc prolongation (screening electrocardiogram with QTc >450 msec for men, QTc> 470 msec for women)
History of QTc prolongation or using concomitant medications (as judged by the Investigator) which prolong QTc interval
Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia

Where it is running

16420 NW 59 Avenue — Miami, Florida, United States

Full record on ClinicalTrials.gov

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