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Unknown

NBI-1117568 for Schizophrenia

Phase 2
Recruiting
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 6
Awards & highlights

Study Summary

This trial tests an experimental drug for schizophrenia to see if it's safe and effective.

Who is the study for?
Adults with schizophrenia who are currently experiencing a worsening of symptoms and need hospitalization can join. They must stop taking any disallowed medications, agree to stay in the hospital for the study, and follow all instructions. People using certain substances or with unstable health conditions, a risk of self-harm, or recent substance abuse issues cannot participate.Check my eligibility
What is being tested?
The trial is testing NBI-1117568's effectiveness and safety against a placebo in adults with schizophrenia during an acute episode. It's well-controlled: participants don't know if they're getting the real drug or placebo, nor do the researchers (double-blind).See study design
What are the potential side effects?
While specific side effects aren't listed here, typically antipsychotic drugs may cause drowsiness, restlessness, weight gain, dry mouth, blurred vision and constipation. The trial will monitor for these common reactions as well as any unique to NBI-1117568.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose Level DExperimental Treatment1 Intervention
Participant administered Dose Level D (6 weeks)
Group II: Dose Level CExperimental Treatment1 Intervention
Participant administered Dose Level C (6 weeks)
Group III: Dose Level BExperimental Treatment1 Intervention
Participant administered Dose Level B (6 weeks)
Group IV: Dose Level AExperimental Treatment1 Intervention
Participant administered Dose Level A (6 weeks)
Group V: Placebo SchedulePlacebo Group1 Intervention
Participant administered placebo (6 weeks)

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,538 Total Patients Enrolled
11 Trials studying Schizophrenia
1,740 Patients Enrolled for Schizophrenia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,364 Total Patients Enrolled
4 Trials studying Schizophrenia
1,060 Patients Enrolled for Schizophrenia

Media Library

NBI-1117568 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05545111 — Phase 2
Schizophrenia Research Study Groups: Dose Level C, Dose Level D, Placebo Schedule, Dose Level A, Dose Level B
Schizophrenia Clinical Trial 2023: NBI-1117568 Highlights & Side Effects. Trial Name: NCT05545111 — Phase 2
NBI-1117568 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05545111 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants enrolled in this experiment?

"Indeed, clinicaltrials.gov indicates that recruitment is in full swing for this medical trial which was posted on October 4th 2022. The last update to the study occurred on October 31st of the same year and they are now looking to enlist 213 patients from 5 different locations."

Answered by AI

Is eligibility for this research trial limited to individuals below the age of seventy?

"This clinical trial is only open to adults aged between 18 and 55. However, there are other trials targeting minors (up to 46) as well as seniors over 65-years old (165)."

Answered by AI

What is the prevalence of this study's implementation in North America?

"At the present moment, this medical trial is recruiting patients from five different sites. These places are located in DeSoto, Berlin and Lemon Grove as well as other locales - be sure to pick a centre closest to you for maximum convenience if you decide to take part."

Answered by AI

Are any new participants being admitted to this clinical trial?

"According to figures posted on clinicaltrials.gov, enrollment for this trial is ongoing and began on October 4th 2022. The most recent update was published at the end of that month."

Answered by AI

Is Dose Level D compliant with FDA standards?

"Given the lack of data on efficacy and presence of safety-related evidence, our team assigned Dose Level D a score of 2."

Answered by AI

Could I potentially qualify for enrollment in this experiment?

"The requirements for enrolment into this trial are strict: 213 individuals between 18 and 55 years old, diagnosed with schizophrenia, who have provided informed consent. In addition to these criteria, the admitted participants must be currently hospitalised due to an exacerbation or relapse of symptoms; any prohibited medications such as antipsychotics should be discontinued before joining the study."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Neurocrine Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
2022. "Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05545111.
All > Schizophrenia
~60 spots leftby Dec 2024
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