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Valbenazine for Schizophrenia

Neurocrine Clinical Site, Rogers, AR
SchizophreniaValbenazine - Drug
Eligibility
Any Age
All Sexes

Study Summary

This trial will evaluate whether valbenazine can improve symptoms of schizophrenia in patients who haven't responded well to antipsychotic treatment.

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Ziprasidone
1
SEP-363856
1
Dose Level A

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Baseline to week 10

Baseline to week 10
Change in CGI-S score from baseline to Week 10
Change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 10
Change in PANSS total score from baseline to Week 10
Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10
Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Ziprasidone
1
SEP-363856
2
Dose Level A

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

Vesicular monoamine transporter 2 (VMAT2) inhibitor
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

400 Total Participants · 2 Treatment Groups

Primary Treatment: Valbenazine · Has Placebo Group · Phase 3

Vesicular monoamine transporter 2 (VMAT2) inhibitor
Drug
Experimental Group · 1 Intervention: Valbenazine · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valbenazine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 10

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
71 Previous Clinical Trials
6,427 Total Patients Enrolled
11 Trials studying Schizophrenia
1,712 Patients Enrolled for Schizophrenia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
22 Previous Clinical Trials
2,261 Total Patients Enrolled
4 Trials studying Schizophrenia
981 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with schizophrenia by a medical professional using the DSM-5 guidelines.

Who else is applying?

What state do they live in?
Texas100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "I'm in a seemingly endless downward spiral with less and less hope for my existence."
How many prior treatments have patients received?
3+100.0%
References

Frequently Asked Questions

Has Valbenazine been cleared by the FDA?

"Valbenazine has received a 3 on Power's safety scale. This is due to the fact that this medication is currently in Phase 3 clinical trials, meaning that there are both supportive efficacy data and multiple rounds of safety data available." - Anonymous Online Contributor

Unverified Answer

Have other research groups conducted similar investigations before?

"Valbenazine has been under study since 2020. The first trial, sponsored by Neurocrine Biosciences, was conducted that year and involved 150 participants. After the initial success of this Phase 3 drug in 2020, there are now 3 active trials for Valbenazine across 52 cities in 2 countries." - Anonymous Online Contributor

Unverified Answer

Are there any Valbenazine-based treatments that have been looked into before?

"Valbenazine was first studied in 2020 at the Neurocrine Clinical Site. Since then, there have been 18300 completed trials with 3 more presently active and recruiting. Many of these latter trials are based out of Garden Grove, California." - Anonymous Online Contributor

Unverified Answer

Are there different research facilities conducting this study across the nation?

"There are presently 19 clinical trial sites for this medication, which can be found in Garden Grove, Lemon Grove, Las Vegas and 16 other cities. If you wish to enroll, it would be best to choose the location nearest you to reduce travel time commitments." - Anonymous Online Contributor

Unverified Answer

Are new participants being accepted for this research project?

"That is correct. The online clinicaltrials.gov registry confirms that, as of 6/27/2022, this study is still actively recruiting patients. 400 individuals are needed for the trial which has 19 enrolment sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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