Study Details

Open

A study to test long-term safety of BI 425809 in people with schizophrenia who took part in a previous CONNEX study

The objective of this trial is to collect additional safety data in patients with cognitive impairment due to schizophrenia, who participated in and completed the 26-week treatment or matching placebo of one of the phase III clinical trial program for BI 425809 (trial # 1346-0011, 1346-0012, 1346-0013).

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

At each in-person visit, you will meet with a member of the study team to complete interviews and questionnaires. The study will also involve vital signs, blood draws, EKGs, and collecting urine samples. There will be 4 telephone visits, where subjects will be asked to review medications and adverse events. Participants must be willing to take the provided study medication everyday for the duration of the study.

Incentives

Information provided upon request. Payments will be received via a Visa gift card., gas reimbursement

In-person visits:
13

Phone or online visits:
4

Total length of participation:
52 weeks

Looking for Specific Volunteers

Able to participate:

Have a diagnosis of schizophrenia
Patients, who completed 26 weeks of treatment in the parent trial (BI 1346-0011, -0012, -0013)..
Must have a study partner, you interact with at least 1 time a week (in-person or telephone)

Not eligible if:

Participant who developed DSM5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial.
Any suicidal behavior and/ or suicidal ideation of type 5 based on the C-SSRS in parent trial and up to and including Visit 1.
Patients diagnosed with moderate or severe substance use disorder
Positive urine drug screen ≥ 3 times during the treatment period of trial 1346-0011, 1346-0012 or 1346-0013 based on central lab test.
Patients with an allergy to BI 425809 and/or any of the excipients (including serious lactose intolerance).

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

North Carolina Psychiatric Research Center
401 East Whitaker Mill Road, Raleigh, NC, USA

Additional Study Information

Principal Investigator

Fred Jarskog
Psychiatry - General

Study Type

Clinical or Medical
Interventional

Study Topics

Chronic Conditions
Mental and Emotional Health

IRB Number

23-1639