Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

NCT04315792 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 0791-17
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar I Disorder

Keywords

Endoxifen, Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy and establish superiority of endoxifen 8 mg against placebo in Bipolar I Disorder patients (Mean change in total YMRS score)

  Mean change in total YMRS score at Day 21 against baseline (in-patient setup)

  3 weeks

Secondary Outcomes (1)

• Evaluate the safety and tolerability of all the treatments among Bipolar I Disorder patients (treatment related adverse events)

  3 weeks

Study Arms (2)

Endoxifen Arm

EXPERIMENTAL

Endoxifen enteric-coated tablet (8 mg). Patients will continue treatment with their initial randomized medication for 3 weeks

Drug: Endoxifen

Placebo Arm

PLACEBO COMPARATOR

Placebo tablets of endoxifen. Patients will continue administration with their initial randomized medication for 3 weeks

Drug: Placebo oral tablet

Interventions

Endoxifen DRUG

Administration of Endoxifen for 3 weeks

Endoxifen Arm

Placebo oral tablet DRUG

Administration of Placebo for 3 weeks

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Jina Pharmaceuticals Inc.: lead
• Novum Pharmaceutical Research Services: collaborator
• Lambda Therapeutic Research Ltd.: collaborator

Study Sites (1)

16420 NW 59 Avenue

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

4-hydroxy-N-desmethyltamoxifen

Study Officials

• Theodore R Treese, MD

  Innovative Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 20, 2020
• Study Start: August 3, 2020
• Primary Completion: January 25, 2021
• Study Completion: August 25, 2021
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)