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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Lu AF35700

• Registration Number: NCT02892422
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.

Detailed Description

Safety study in patients with schizophrenia who have participated and completed a study investigating Lu AF35700 including Studies 16159A and 16323A. Or in patients with schizophrenia for whom a switch of antipsychotic treatment can be potentially beneficial according to the investigator's clinical judgement.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Primary Completion: 2019-10-10
• Study Completion: 2019-10-10
• Status Verified: 2020-09
• Results First Submitted: 2020-09-30
• Results First Submitted QC: 2020-09-30
• Last Update Submitted: 2020-09-30
• Results First Posted: 2020-10-26
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 528

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flexible-dose of Lu AF35700	Lu AF35700	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)	From dosing to end of study (57 weeks)	Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG)

Trial Locations

Locations (102)

US1018; 🇺🇸 Bellflower, California, United States

US1062; 🇺🇸 Costa Mesa, California, United States

US1463; 🇺🇸 Culver City, California, United States

US1399; 🇺🇸 Escondido, California, United States

US1104; 🇺🇸 Garden Grove, California, United States

US1114; 🇺🇸 National City, California, United States

US1459; 🇺🇸 Oceanside, California, United States

US1368; 🇺🇸 Orange, California, United States

US1391; 🇺🇸 San Bernardino, California, United States

US1392; 🇺🇸 Torrance, California, United States

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