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Tests treatment safety and results for Bipolar Disorder Type I With Mania
Official title A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
ClinicalTrials.gov ID: NCT06929273
What this study is testing
What is KarXT?
KarXT is an investigational medicine, being studied as a potential treatment for bipolar disorder type i with mania.
Also referred to as BMS-986510, Xanomeline and trospium chloride.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Participants who participated in blinded compared with an inactive treatment study (CN0120036, CN0120037, or CN0120046): a. Participants must have...
- De novo participants who did not participate in blinded compared with an inactive treatment studies:
- Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and...
- Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
- Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
You likely can't join if
- Participants who participated in blinded compared with an inactive treatment study (CN0120036, CN0120037, or CN0120046): a. Discontinuation from any...
- De novo participants who did not participate in blinded compared with an inactive treatment studies:
- All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as...
- Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
- Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening...
- Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening...
See the full eligibility criteria
- Participants who participated in blinded compared with an inactive treatment study (CN0120036, CN0120037, or CN0120046): a. Participants must have completed treatment period of parent study.
- De novo participants who did not participate in blinded compared with an inactive treatment studies:
- Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI...
- Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
- Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
- Participants does not require hospitalization for acute mania.
- Participants who participated in blinded compared with an inactive treatment study (CN0120036, CN0120037, or CN0120046): a. Discontinuation from any KarXT parent studies.
- De novo participants who did not participate in blinded compared with an inactive treatment studies:
- All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.
- Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
- Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with...
- Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as...
- Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, Arizona, United States
- Bentonville, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Anaheim, California, United States
- Bellflower, California, United States
- Cerritos, California, United States
- Chino, California, United States
- Culver City, California, United States
- Garden Grove, California, United States
- La Habra, California, United States
- Montclair, California, United States
- Orange, California, United States
- Riverside, California, United States
- Santa Ana, California, United States
- Torrance, California, United States
- New Haven, Connecticut, United States
- Hallandale, Florida, United States
- Hialeah Gardens, Florida, United States
- Hollywood, Florida, United States
+ 130 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, Arizona, United States; Bentonville, Arkansas, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Anaheim, California, United States; Bellflower, California, United States and 144 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.