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NCT01874756 · ClinicalTrials.gov registry record · Phase 2
The Efficacy and Safety of a Selective Estrogen Receptor Beta Agonist (LY500307) for Negative Symptoms and Cognitive Impairment Associated With Schizophrenia
A Phase 2 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT01874756 is a Phase 2 study that was terminated before completion, run by Indiana University. The registered enrollment target is 95 participants.
The verdict
NCT01874756, a Phase 2 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
The primary objectives of this application are to determine if the selective ERβ agonist LY500307, when added to antipsychotic medications, improves negative and/or cognitive symptoms in patients with schizophrenia. The specific hypotheses to be tested are to determine if LY500307 is safe and well tolerated in this population and whether it elicits a sufficient efficacy signal to be advanced for further testing in schizophrenia. A two-stage Phase 1b/Phase 2a adaptive ("drop the inferior dose") experimental design is ongoing that combines three studies (clinical dose optimization, cortical target engagement confirmation and efficacy and safety assessment) into a single clinical trial. Stage 1 was conducted in year 1 and Stage 2 will be conducted in years 2 and 3. The goal of Stage 1 was to identify and advance the highest dose that did not demonstrate a safety signal and had target selectivity as determined by lack of TT suppression. This criteria was fulfilled at both doses, the larger of the two (75 mg/day dose) was advanced to Stage 2. Furthermore, there was no suggestion of ERα receptor activation (i.e., no pattern of TT decreases or feminization AEs) at either dose (25 mg/day and 75 mg/day). A third arm of 150 mg/day was added to Stage 2 for evaluation. Stage 2 results in the following three arms: placebo, 75 mg/day and 150 mg/day. The goals of Stage 2 are to further assess LY500307 doses for safety and target selectivity, confirm cortical target engagement and assess efficacy. Primary Aim 1: To determine if LY500307 demonstrates cortical target engagement as assessed by fMRI/N-back in frontal-parietal regions. Secondary measures of target engagement are fMRI episodic memory, Pseudo-Continuous Arterial Spin Labeling, Mismatch Negativity/evoked response potentials, Auditory Steady State Response, Auditory P300 and Quantitative EEG (QEEG). Primary Aim 2: To determine if LY500307 is superior to placebo for one or more of the primary efficacy endpoints: negative
Interventions
- DRUG Placebo
- DRUG LY500307 150mg
- DRUG LY500307 75mg
- DRUG LY500307 25mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2013-06 |
| Est. Completion | 2017-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01874756
The ClinicalTrials.gov registry entry for NCT01874756 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01874756 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01874756 about?
NCT01874756 is a clinical study titled "The Efficacy and Safety of a Selective Estrogen Receptor Beta Agonist (LY500307) for Negative Symptoms and Cognitive Impairment Associated With Schizophrenia". The primary objectives of this application are to determine if the selective ERβ agonist LY500307, when added to antipsychotic medications, improves negative and/or cognitive symptoms in patients with schizophrenia. The specific hypotheses to be tested are to determine if LY500307 is safe and well t...
What is the current status of trial NCT01874756?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2013-06. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01874756?
The interventions under investigation include: Placebo (DRUG), LY500307 150mg (DRUG), LY500307 75mg (DRUG), LY500307 25mg (DRUG).
Who is sponsoring clinical trial NCT01874756?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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