BridgeMD
Tests treatment safety and results for Schizophrenia
Official title An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
ClinicalTrials.gov ID: NCT05304767
What this study is testing
What is Xanomeline and Trospium Chloride Capsules?
Xanomeline and Trospium Chloride Capsules is an investigational medicine, given as an once-daily, being studied as a potential treatment for schizophrenia.
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, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily [BID]) in subjects with schizophrenia.
- Phase 3: a large, late-stage study
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
- Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012
- Subject has successfully completed the treatment period of Study KAR-012
- Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement)
- Subject has been compliant with their background antipsychotic drug in Study KAR-012 in the opinion of the Investigator and based on subject and...
- Subject is capable of providing signed Informed Consent Form before any study assessments will be performed
You likely can't join if
- Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment and/or Columbia-Suicide Severity Rating Scale...
- Subject answers "Yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without a specific plan) or Item 5 (active...
- Non-suicidal self-injurious behavior is not exclusionary
- Any clinically significant abnormalities, including any finding(s) from ECG, or laboratory test at Visit 6, and the physical examination, vital...
- Female subject is pregnant
- If, in the opinion of the Investigator (and/or Sponsor/ Medical Monitor), subject is unsuitable for enrollment in the study or subject has any...
See the full eligibility criteria
- Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012
- Subject has successfully completed the treatment period of Study KAR-012
- Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement)
- Subject has been compliant with their background antipsychotic drug in Study KAR-012 in the opinion of the Investigator and based on subject and informant reporting Note: people are required to remain on the same...
- Subject is capable of providing signed Informed Consent Form before any study assessments will be performed
- Subject resides in a stable living situation, in the opinion of the Investigator
- Subject has identified a reliable informant/caregiver willing and able to assist with study activities as needed throughout the subject's participation in the study. The informant can complete the study visits...
- Women of childbearing potential (WOCP), or men whose sexual partners are WOCP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle...
- Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment and/or Columbia-Suicide Severity Rating Scale (C-SSRS) as confirmed by the following:
- Subject answers "Yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without a specific plan) or Item 5 (active suicidal ideation with a specific plan and intent) on the C-SSRS
- Non-suicidal self-injurious behavior is not exclusionary
- Any clinically significant abnormalities, including any finding(s) from ECG, or laboratory test at Visit 6, and the physical examination, vital signs, at the EOT visit of Study KAR-012 that the Investigator, in...
- Female subject is pregnant
- If, in the opinion of the Investigator (and/or Sponsor/ Medical Monitor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator (and/or Sponsor /Medical...
- Risk of violent or destructive behavior as per Investigator's judgement
- people participating in another investigational drug or device trial or planning on participating in another clinical trial during the study
- History or high risk of urinary retention, gastric retention, or narrow angle glaucoma as evaluated by the Investigator
- Subject is taking, or plans to take while in the study, any prohibited concomitant medication
- For all male people only, any one of the following:
- History of bladder stones
- History of recurrent urinary tract infections
- Serum prostate specific antigen (PSA) \>10 ng/mL
- An International Prostate Symptom Score (IPSS) of 5 (almost always) on either item 1, 3, 5, or 6
- A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9 Note: IPSS will be required only for male people ≥ 45 years of age. people already enrolled in the study who do not have available PSA values from Study KAR-012 for...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Bellflower, California, United States
- Cerritos, California, United States
- Culver City, California, United States
- Garden Grove, California, United States
- La Habra, California, United States
- Lafayette, California, United States
- Lemon Grove, California, United States
- Los Angeles, California, United States
- Oceanside, California, United States
- Orange, California, United States
- Pico Rivera, California, United States
- Riverside, California, United States
- San Diego, California, United States
- Stanford, California, United States
- Torrance, California, United States
- Coral Gables, Florida, United States
- Hialeah, Florida, United States
+ 113 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 Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Anaheim, California, United States; Bellflower, California, United States; Cerritos, California, United States; Culver City, California, United States and 127 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.