Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02892422
• Date of registration: 29/08/2016
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia Debut
• Scientific title: Interventional, Open-label, Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
• Date of first enrolment: August 2016
• Target sample size: 528
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02892422
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, Czechia, Estonia, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Ukraine, United States

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

Inclusion Criteria:

- For 16159A-patients

- The patient has completed Study 16159A.

- The patient is able to read and understand the Informed Consent Form.

- The patient has signed the Informed Consent Form specific for Study 16159B.

- The patient can potentially benefit from 52-week treatment with Lu AF35700 according
to the investigator's clinical judgement.

For 16323A-patients

- The patient has completed the dosing period of Study 16323A.

- The patient is able to read and understand the Informed Consent Form.

- The patient has signed the Informed Consent Form specific Study 16159B.

- The patient has a confirmed diagnosis of schizophrenia according to DSM-5™.

- The patient can potentially benefit from 52-week treatment with Lu AF35700 according
to the investigator's clinical judgement.

For Other Patients

- The patient has schizophrenia, diagnosed according to DSM-5™.

- The patient is a man or woman, aged =18 years.

- The patient has been prescribed oral antipsychotic treatment at the recommended dose
range as stated in the summary of product characteristics or equivalent label for 6
weeks prior to the Screening Visit.

- The patient has a PANSS total score =60 and =90 at Screening and Baseline Visits.

- The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score =4.

- The patient is in need of a change in the current antipsychotic treatment and,
according to the investigator's clinical judgement, the patient can potentially
benefit from a switch to another treatment including, but not limited to, any of the
following reasons:

- lack of adequate response to his or her current antipsychotic medication;

- poor tolerability to his or her current antipsychotic medication;

- unwillingness of the patient to adhere to his or her current antipsychotic
medication.

Exclusion Criteria:

- For 16159A-patients

- The patient has been diagnosed with a primary psychiatric disorder other than
schizophrenia during Study 16159A.

- The patient, in the opinion of the investigator, is at significant risk of suicide,
or: Answers "Yes" to any question on the Suicidal Behaviour section of the
Columbia-Suicide Severity Rating Scale (C-SSRS), OR Answers "Yes" to questions 4 and 5
on the Suicidal Ideation section of the C-SSRS

For 16323A-patients

- The patient has been diagnosed with a primary psychiatric disorder other than
schizophrenia during Study 16323A.

- The patient, in the opinion of the investigator, is at significant risk of suicide,
or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR
Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS

For Other Patients

- The patient has any current psychiatric disorder (DSM-5™ criteria) other than
schizophrenia established as the primary diagnosis.

- The patient is experiencing acute exacerbation of psychotic symptoms at the Screening
Visit, between the Screening and Baseline Visits or at the Baseline Visit.

- The patient is treated with clozapine at the time of the Screening Visit.

- The patient has a substance use disorder (except nicotine) which according to the
investigator's judgment may compromise the patient's ability to comply with the study
procedures, or preclude the benefits of the study medication.

- The patient, in the opinion of the investigator, is at significant risk of suicide,
or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR
Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS

Other protocol defined inclusion and exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Lu AF35700

Primary Outcome(s)

Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) [Time Frame: From dosing to end of study (57 weeks)]

Secondary ID(s)

16159B

2015-003284-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02892422