Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

Recruiting · NCT07686263 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Who can take part

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:
Item 1 (P1; delusions)
Item 2 (P2; conceptual disorganization)
Item 3 (P3; hallucinatory behavior)
Item 6 (P6; suspiciousness/persecution)
Participant must have a CGI-S score of ≥ 4 at screening and Day -1
Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.

Exclusion criteria

Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
Participant must not have a history of treatment resistance to schizophrenia medications
Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

59 locations listed across 9 US states.

Pillar Clinical Research - Bentonville - Bentonville, Arkansas, United States
Pillar Clinical Research- Little Rock - Little Rock, Arkansas, United States
Local Institution - 0021 - Little Rock, Arkansas, United States
Local Institution - 0153 - Rogers, Arkansas, United States
Local Institution - 0190 - Anaheim, California, United States
Local Institution - 0040 - Bellflower, California, United States
Local Institution - 0188 - Chino, California, United States
Local Institution - 0032 - Culver City, California, United States
Local Institution - 0037 - Garden Grove, California, United States
Local Institution - 0068 - La Habra, California, United States
Local Institution - 0128 - Lemon Grove, California, United States
Local Institution - 0187 - Montclair, California, United States
Local Institution - 0151 - Orange, California, United States
Local Institution - 0030 - Pico Rivera, California, United States
Local Institution - 0185 - Redlands, California, United States
Local Institution - 0186 - Riverside, California, United States
Local Institution - 0193 - Torrance, California, United States
Research Centers of America ( Hollywood ) - Hollywood, Florida, United States
Local Institution - 0075 - Miami, Florida, United States
Local Institution - 0054 - Miami Lakes, Florida, United States
Local Institution - 0134 - Miami Springs, Florida, United States
Local Institution - 0195 - Oakland Park, Florida, United States
Local Institution - 0044 - West Palm Beach, Florida, United States
Atlanta Center for Medical Research - Atlanta, Georgia, United States
Local Institution - 0070 - Sandy Springs, Georgia, United States
Local Institution - 0189 - Savannah, Georgia, United States
Local Institution - 0067 - Chicago, Illinois, United States
Local Institution - 0056 - Chicago, Illinois, United States
Local Institution - 0192 - Gaithersburg, Maryland, United States
Local Institution - 0183 - Cincinnati, Ohio, United States
Local Institution - 0047 - Oklahoma City, Oklahoma, United States
Local Institution - 0049 - Austin, Texas, United States
Local Institution - 0194 - Dallas, Texas, United States
Pillar Clinical Research - Richardson - Richardson, Texas, United States
Local Institution - 0158 - Aalborg, Denmark
Local Institution - 0162 - Brno, Czechia
Local Institution - 0174 - Bucharest, Romania
Local Institution - 0106 - Bucharest, Romania
Local Institution - 0109 - Bucharest, Romania
Local Institution - 0143 - Buenos Aires, Argentina
Local Institution - 0094 - Cambridge, United Kingdom
Local Institution - 0002 - Córdoba, Argentina
Local Institution - 0014 - Klecany, Czechia
Local Institution - 0191 - Novi Iskar, Bulgaria
Local Institution - 0001 - Poznan, Poland
Local Institution - 0144 - Santiago del Estero, Argentina
Local Institution - 0167 - Valladolid, Spain
Local Institution - 0181 - Zamora, Spain
Local Institution - 0112 - Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0103 - Bucharest, Bucharest, Romania
Local Institution - 0105 - Bucharest, Bucharest, Romania
Local Institution - 0107 - Bucharest, Bucharest, Romania
Local Institution - 0110 - Bucharest, Bucharest, Romania
Local Institution - 0159 - Aarhus, Central Jutland, Denmark
Local Institution - 0175 - Río Cuarto, Córdoba Province, Argentina
Local Institution - 0182 - Hovedvejen 19, Frederiksberg, Denmark
Local Institution - 0123 - Warsaw, Masovian Voivodeship, Poland
Local Institution - 0122 - Bialystok, Podlaskie Voivodeship, Poland
Local Institution - 0157 - Glostrup, Region Sjælland, Denmark

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →