Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Lu AF11167 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 96 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Interventional, Open-label, Flexible-dose, Long-term Safety Extension Study of Lu AF11167 in Patients With Schizophrenia |
Actual Study Start Date : | April 22, 2019 |
Actual Primary Completion Date : | September 1, 2020 |
Actual Study Completion Date : | September 14, 2020 |
Arm | Intervention/treatment |
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Experimental: Lu AF11167 |
Drug: Lu AF11167
Lu AF11167 - 2 or 4 mg/day; tablets, orally
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other in- and exclusion criteria may apply
Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com |
Tracking Information | |||||
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First Submitted Date ICMJE | April 24, 2019 | ||||
First Posted Date ICMJE | April 26, 2019 | ||||
Last Update Posted Date | September 23, 2020 | ||||
Actual Study Start Date ICMJE | April 22, 2019 | ||||
Actual Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of participants with Treatment-Emergent Adverse Events [ Time Frame: From baseline week 24 ] Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, BMI, waist, weight, ECG parameters)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms | ||||
Official Title ICMJE | Interventional, Open-label, Flexible-dose, Long-term Safety Extension Study of Lu AF11167 in Patients With Schizophrenia | ||||
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 | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Schizophrenia | ||||
Intervention ICMJE | Drug: Lu AF11167
Lu AF11167 - 2 or 4 mg/day; tablets, orally
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Study Arms ICMJE | Experimental: Lu AF11167
Intervention: Drug: Lu AF11167
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
96 | ||||
Original Estimated Enrollment ICMJE |
240 | ||||
Actual Study Completion Date ICMJE | September 14, 2020 | ||||
Actual Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Other in- and exclusion criteria may apply |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Bulgaria, Estonia, Germany, Hungary, Latvia, Poland, Ukraine | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03929497 | ||||
Other Study ID Numbers ICMJE | 17972B | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | H. Lundbeck A/S | ||||
Study Sponsor ICMJE | H. Lundbeck A/S | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | H. Lundbeck A/S | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |