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NCT03230864 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia
A Phase 3 study, sponsored by H. Lundbeck A/S.
- Terminated
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT03230864: Clinical Trial Phase 3 study, sponsored by H. Lundbeck A/S.
NCT03230864 is a Phase 3 study that was terminated before completion, run by H. Lundbeck A/S. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03230864, a Phase 3 study, was terminated before completion, sponsored by H. Lundbeck A/S.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study Summary
This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS)
Primary Outcome
PANSS total score administered by the investigator. It included a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A negative score indicates an improvement compared to Randomization.
Interventions
- DRUG Risperidone
- DRUG Olanzapine
- DRUG Lu AF35700
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2017-07-20 |
| Est. Completion | 2019-02-05 |
| Phase | Phase 3 |
Why NCT03230864 stopped before completion
NCT03230864 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Risperidone is the first listed.
NCT03230864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03230864 about?
NCT03230864 is a clinical study titled "Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia". This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS)
What is the current status of trial NCT03230864?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2017-07-20. Estimated completion is 2019-02-05.
What interventions are being tested in trial NCT03230864?
The interventions under investigation include: Risperidone (DRUG), Olanzapine (DRUG), Lu AF35700 (DRUG).
Who is sponsoring clinical trial NCT03230864?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03230864's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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