Trial studying safety and effects 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 oral medication being studied for the treatment of mania in Bipolar-I disorder.
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
- The study aims to determine how safe and tolerable KarXT is over a long period for people with mania or mixed mania in bipolar‑I disorder.
- Who it's for
- Adults with bipolar‑I disorder who are experiencing a manic episode or mixed features.
- What's involved
- Participants will take KarXT and attend regular clinic visits for safety monitoring and tests.
- Time commitment
- The study lasts many months, with scheduled visits for medication and safety assessments.
- 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 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.
- Participants does not require hospitalization for acute mania.
You likely can't join if
- All participants: 1\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history...
- Participants who participated in blinded compared with an inactive treatment study (CN0120036, CN0120037, or CN0120046): 1\.
- 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...
- Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the...
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.
- 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.
- All participants: 1\. 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 who participated in blinded compared with an inactive treatment study (CN0120036, CN0120037, or CN0120046): 1\. Discontinuation from any KarXT parent studies.
- 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 is enrolling
- Bentonville, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Anaheim, California, United States
- Bellflower, 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
- Torrance, California, United States
- New Haven, Connecticut, United States
- Boynton Beach, Florida, United States
- Hallandale, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Miami Springs, Florida, United States
+ 90 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, but 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?
This study is enrolling now at Bentonville, Arkansas, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Anaheim, California, United States; Bellflower, California, United States; Chino, California, United States and 104 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.