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4 Diseases |  |
1 Trial |
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1 Trial |  |
25 News |  |
- || Lu AF11167 / Lundbeck
Clinical, Journal: 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. (Pubmed Central) - Aug 18, 2022
P2
Neither dose group showed significant improvements versus placebo on any of the secondary efficacy measures exploring effect of treatment on overall symptomology, negative symptoms, positive symptoms, or functioning. Administration of Lu AF11167 was safe and well tolerated and adverse events were not a major reason for withdrawal from the study.
- | Lu AF11167 / Lundbeck
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms (clinicaltrials.gov) - Sep 22, 2020
P2, N=96, Terminated, Sponsor: H. Lundbeck A/S
Administration of Lu AF11167 was safe and well tolerated and adverse events were not a major reason for withdrawal from the study. N=240 --> 96 | Trial completion date: Jul 2021 --> Sep 2020 | Enrolling by invitation --> Terminated | Trial primary completion date: Jul 2021 --> Sep 2020; Lack of efficacy based on the interim analysis in the 17972A study
- | Lu AF11167 / Lundbeck
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia (clinicaltrials.gov) - Sep 22, 2020
P2, N=168, Terminated, Sponsor: H. Lundbeck A/S
N=240 --> 96 | Trial completion date: Jul 2021 --> Sep 2020 | Enrolling by invitation --> Terminated | Trial primary completion date: Jul 2021 --> Sep 2020; Lack of efficacy based on the interim analysis in the 17972A study N=240 --> 168 | Trial completion date: Feb 2021 --> Sep 2020 | Recruiting --> Terminated | Trial primary completion date: Feb 2021 --> Aug 2020; Lack of efficacy based on interim analysis
- | Journal: Keeping up with the therapeutic advances in schizophrenia: a review of novel and emerging pharmacological entities. (Pubmed Central) - Aug 4, 2020
Most of these trial programs are still ongoing or have yielded mixed or even negative results. Thus, additional mechanisms of action and agents require study to improve schizophrenia outcomes for total/positive symptoms with reduced adverse effects, but also cognitive symptoms, negative symptoms, and treatment resistance, the areas of greatest need in schizophrenia currently.
- || Lu AF11167 / Lundbeck
Trial completion date, Trial primary completion date: Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia (clinicaltrials.gov) - Jun 9, 2020
P2, N=240, Recruiting, Sponsor: H. Lundbeck A/S
Thus, additional mechanisms of action and agents require study to improve schizophrenia outcomes for total/positive symptoms with reduced adverse effects, but also cognitive symptoms, negative symptoms, and treatment resistance, the areas of greatest need in schizophrenia currently. Trial completion date: Nov 2020 --> Feb 2021 | Trial primary completion date: Nov 2020 --> Feb 2021
- || Lu AF11167 / Lundbeck
Trial completion date, Trial primary completion date: Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms (clinicaltrials.gov) - Jun 9, 2020
P2, N=240, Enrolling by invitation, Sponsor: H. Lundbeck A/S
Trial completion date: Nov 2020 --> Feb 2021 | Trial primary completion date: Nov 2020 --> Feb 2021 Trial completion date: Dec 2020 --> Jul 2021 | Trial primary completion date: Dec 2020 --> Jul 2021
- || Lu AF11167 / Lundbeck
Trial completion: A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects (clinicaltrials.gov) - Apr 16, 2020
P1, N=33, Completed, Sponsor: H. Lundbeck A/S
Trial completion date: Dec 2020 --> Jul 2021 | Trial primary completion date: Dec 2020 --> Jul 2021 Recruiting --> Completed
- || Lu AF11167 / Lundbeck
Trial completion date, Trial primary completion date: Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia (clinicaltrials.gov) - Feb 17, 2020
P2, N=240, Recruiting, Sponsor: H. Lundbeck A/S
Recruiting --> Completed Trial completion date: May 2020 --> Nov 2020 | Trial primary completion date: May 2020 --> Nov 2020
- | Lu AF11167 / Lundbeck
New P1 trial: A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects (clinicaltrials.gov) - Sep 25, 2019
P1, N=33, Recruiting, Sponsor: H. Lundbeck A/S
- || Lu AF11167 / Lundbeck
Trial completion date, Trial primary completion date: Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms (clinicaltrials.gov) - May 24, 2019
P2, N=240, Enrolling by invitation, Sponsor: H. Lundbeck A/S
Trial completion date: May 2020 --> Nov 2020 | Trial primary completion date: May 2020 --> Nov 2020 Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020
- ||||| Lu AF11167 / Lundbeck
New P2 trial: Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms (clinicaltrials.gov) - Apr 25, 2019
P2, N=240, Enrolling by invitation, Sponsor: H. Lundbeck A/S
- ||||| Lu AF11167 / Lundbeck
New P2 trial: Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia (clinicaltrials.gov) - Jan 4, 2019
P2, N=240, Recruiting, Sponsor: H. Lundbeck A/S
- | Lu AF11167 / Lundbeck
Trial completion, Trial primary completion date: Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers. (clinicaltrials.gov) - Sep 21, 2015
P1, N=20, Completed, Sponsor: H. Lundbeck A/S
Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020 Recruiting --> Completed | Trial primary completion date: Sep 2015 --> Feb 2015
- Lu AF11167 / Lundbeck
Trial primary completion date: Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers. (clinicaltrials.gov) - Aug 21, 2015
P1, N=20, Recruiting, Sponsor: H. Lundbeck A/S
Recruiting --> Completed | Trial primary completion date: Sep 2015 --> Feb 2015 Trial primary completion date: Jun 2015 --> Sep 2015
- Lu AF11167 / Lundbeck
Trial primary completion date: Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers. (clinicaltrials.gov) - Apr 14, 2015
P1, N=20, Recruiting, Sponsor: H. Lundbeck A/S
Trial primary completion date: Jun 2015 --> Sep 2015 Trial primary completion date: Dec 2014 --> Jun 2015
- | Lu AF11167 / Lundbeck
Trial completion: Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167 (clinicaltrials.gov) - Mar 7, 2015
P1, N=28, Completed, Sponsor: H. Lundbeck A/S
Trial primary completion date: Dec 2014 --> Jun 2015 Recruiting --> Completed
- | Lu AF11167 / Lundbeck
Trial completion, Enrollment change: Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia (clinicaltrials.gov) - Feb 19, 2015
P1, N=47, Completed, Sponsor: H. Lundbeck A/S
Recruiting --> Completed Recruiting --> Completed | N=72 --> 47
- || Lu AF11167 / Lundbeck
Trial primary completion date: Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia (clinicaltrials.gov) - Nov 28, 2014
P1, N=72, Recruiting, Sponsor: H. Lundbeck A/S
Recruiting --> Completed | N=72 --> 47 Trial primary completion date: Oct 2014 --> Jan 2015
- | Lu AF11167 / Lundbeck
New P1 trial: Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167 (clinicaltrials.gov) - Oct 11, 2014
P1, N=28, Recruiting, Sponsor: H. Lundbeck A/S
- Lu AF11167 / Lundbeck
Enrollment open: Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167 (clinicaltrials.gov) - Oct 11, 2014
P1, N=28, Recruiting, Sponsor: H. Lundbeck A/S
Trial primary completion date: Oct 2014 --> Jan 2015 Not yet recruiting --> Recruiting
- ||| Lu AF11167 / Lundbeck
New P1 trial: Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia (clinicaltrials.gov) - Jul 28, 2014
P1, N=72, Recruiting, Sponsor: H. Lundbeck A/S
- | Lu AF11167 / Lundbeck
New P1 trial: Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers. (clinicaltrials.gov) - Jul 24, 2014
P1, N=20, Recruiting, Sponsor: H. Lundbeck A/S