Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms

NCT03929497 | Terminated Phase 2

• 1 other identifier: 17972B
• Study Type: interventional
• Target: 96
• Locations: 7 countries
• Sites: 30

Brief Summary

A study to evaluate the long-term safety and tolerability of flexible doses of Lu AF11167 in patients with schizophrenia during the 24-week treatment period

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Number of participants with Treatment-Emergent Adverse Events

  Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, BMI, waist, weight, ECG parameters)

  From baseline week 24

Secondary Outcomes (6)

• Change in Brief Negative Symptom Scale (BNSS) total score

  from baseline to Week 24

• Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score

  from baseline to Week 24

• Change in PANSS Negative subscale score

  from baseline to Week 24

• Change in CGI-SCH-S negative symptoms score

  from baseline to Week 24

• CGI-SCH-DC negative symptoms score

  at Week 24

Study Arms (1)

Lu AF11167

EXPERIMENTAL

Drug: Lu AF11167

Interventions

Lu AF11167 DRUG

Lu AF11167 - 2 or 4 mg/day; tablets, orally

Lu AF11167

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient completed Study 17972A.
• The patient and the patient's caregiver or identified responsible person is able to read and understand the Informed Consent Form.
• The patient has signed the Informed Consent Form specific for Study 17972B.
• The patient can potentially benefit from 24 weeks of treatment with Lu AF11167 according to the investigator's clinical judgment.

You may not qualify if:

• The patient has any current primary psychiatric disorder other than schizophrenia diagnosed during study 17972A
• The patient, in the opinion of the investigator, is at significant risk of suicide

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (30)

Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001)

Burgas, Bulgaria

Location

MHAT Dr. Hristo Stambolski (BG0007)

Kazanlak, Bulgaria

Location

First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010)

Novi Iskar, Bulgaria

Location

UMHAT Dr.Georgi Stranski EAD (BG0006)

Pleven, 5800, Bulgaria

Location

State Psychiatric Hospital - Sevlievo (BG0009)

Sevlievo, 5400, Bulgaria

Location

Medical Center INTERMEDICA (BG0003)

Sofia, Bulgaria

Location

DCC Mladost-M (BG0004)

Varna, 9000, Bulgaria

Location

Med Centre Medical plus (BG0008)

Varna, 9000, Bulgaria

Location

DCC Mladost-M Varna OOD (BG0005)

Varna, Bulgaria

Location

Mental Health Center-Vratsa EOOD (BG0002)

Vratsa, Bulgaria

Location

Marienthali Kliinik (EE0001)

Tallinn, Estonia

Location

OU Jaanson & Laane (EE0002)

Tartu, Estonia

Location

Office of Dr.Kirsten Hahn MD (DE0002)

Berlin, Germany

Location

Semmelweis Egyetem Neurologiai Klinika-Semmelweis University (HU0005)

Budapest, 1083, Hungary

Location

Bugat Pal Hospital (HU0008)

Gyöngyös, 3200, Hungary

Location

Dr Mathe es Tarsa Bt (HU0001)

Kalocsa, Hungary

Location

Javorszky Odon Hospital (HU0004)

Vác, Hungary

Location

Hospital Gintermuiza (LV0001)

Jelgava, Latvia

Location

Riga Centre Of Psychiatry And Addiction Disorders (LV0002)

Riga, Latvia

Location

Sigulda Hospital Outpatient Clinic (LV0006)

Sigulda, Latvia

Location

Syntonia Sp. z o.o. (PL0002)

Pruszcz Gdański, 83000, Poland

Location

Si Inpn Namsu (Ua0003)

Kharkiv, 61068, Ukraine

Location

Si Inpn Namsu (Ua0008)

Kharkiv, Ukraine

Location

Kherson Regional Psychiatric Hospital (UA0009)

Kherson, Ukraine

Location

Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005)

Kiev, Ukraine

Location

Regional Clinical Psychiatry Hospital of Kirovograd Regional Council, Donetsk National Medical University (UA0004)

Kropyvnytskyi, Ukraine

Location

"Kyiv Railway Clinical Hospital ¿1 of Branch ""Health Center"" of the Public joint stock company ""Ukrainian Railway"", psychoneurological department" (UA0007)

Kyiv, 1030, Ukraine

Location

Odessa Regional Medical Centre of Mental Health (UA0006)

Odesa, Ukraine

Location

Ukrainian Medical Stomatological Academy (UA0001)

Poltava, Ukraine

Location

Vinnitsa National Medical University (UA0002)

Vinnytsia, Ukraine

Location

Related Publications (1)

• Meyer-Lindenberg A, Nielsen J, Such P, Lemming OM, Zambori J, Buller R, der Goltz CV. A double-blind, randomized, placebo-controlled proof of concept study of the efficacy and safety of Lu AF11167 for persistent negative symptoms in people with schizophrenia. Eur Neuropsychopharmacol. 2022 Aug;61:4-14. doi: 10.1016/j.euroneuro.2022.05.009. Epub 2022 Jun 12.

  PMID: 35704951 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 26, 2019
• Study Start: April 22, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 14, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

PL (1); UA (9); DE (1); ES (2); HU (4); BU (10); LA (3)