All > Paid Studies Austin > Schizophrenia

LYN-005 Containing 15-mg Risperidone for Schizophrenia

Community Clinical Research, Inc., Austin, TX
Schizophrenia+1 More ConditionsRisperidone - Drug
Eligibility
18 - 64
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a long-acting pill form of a drug to treat mental health issues. It will assess the safety, efficacy, and how the body absorbs it.

Eligible Conditions
  • Schizophrenia
  • Schizoaffective Disorder

Treatment Effectiveness

Phase-Based Effectiveness

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

Similar Trials

1
Focused Ultrasound
1
Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg
1
CMTX-101 30 mg/kg

Study Objectives

5 Primary · 2 Secondary · Reporting Duration: up to Day 36

Week 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) to Week 5
Week 5
Number of Participants with Treatment Emergent Adverse Events (TEAEs) From Week 1 to Week 5
up to Day 36
Average Concentration Over the Dosing Interval (Cavg) at Week 5
Maximal Observed Concentration (Cmax) at Week 5
Minimum Observed Concentration (Cmin) at Week 1
Minimum Observed Concentration (Cmin) at Week 1 and Week 5
Minimum Observed Concentration (Cmin) at Week 5

Trial Safety

Phase-Based Safety

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

Similar Trials

1
Focused Ultrasound
1
Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg
1
CMTX-101 30 mg/kg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

LYN-005 Containing 15-mg Risperidone
1 of 2
LYN-005 Containing 45-mg Risperidone
1 of 2

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: LYN-005 Containing 15-mg Risperidone · No Placebo Group · Phase 3

LYN-005 Containing 15-mg RisperidoneExperimental Group · 2 Interventions: Risperidone, LYN-005 · Intervention Types: Drug, Drug
LYN-005 Containing 45-mg RisperidoneExperimental Group · 2 Interventions: Risperidone, LYN-005 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risperidone
2011
Completed Phase 4
~3570
LYN-005
2020
Completed Phase 2
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 36

Who is running the clinical trial?

Lyndra Inc.Lead Sponsor
5 Previous Clinical Trials
85 Total Patients Enrolled
1 Trials studying Schizophrenia
34 Patients Enrolled for Schizophrenia
Richard Scranton, MD, MPHPrincipal InvestigatorLyndra Therapeutics INC
2 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Schizophrenia
34 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age 18 - 64 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Does this experiment accommodate participants older than eighteen years?

"This trial has a lower age limit of 18 and an upper age boundary at 64, in accordance with the study's conditions for eligibility." - Anonymous Online Contributor

Unverified Answer

What are the prerequisites to becoming a participant in this research endeavor?

"To be eligible to participate in this trial, applicants must have schizophrenia and fall within the stipulated age range (18-64). Approximately 90 recruits are desired." - Anonymous Online Contributor

Unverified Answer

Do you still have slots available for participants in this experiment?

"Clinicaltrials.gov reveals that this medical investigation is still recruiting subjects; the trial was initially posted on April 1st 2023 and updated for the last time on April 13th 23rd." - Anonymous Online Contributor

Unverified Answer

Has the FDA approved a formulation of risperidone with 45-mg LYN-005?

"There is already existing clinical data that suggests the safety of LYN-005 Containing 45-mg Risperidone, so it received a rating of 3." - Anonymous Online Contributor

Unverified Answer

Could you provide a figure for the number of participants involved in this clinical experiment?

"To complete the trial, 90 participants who meet our inclusion criteria must be recruited. These volunteers can sign up at either Atlanta Center for Medical Research in Georgia or Uptown Research Institute in Illinois." - Anonymous Online Contributor

Unverified Answer

How many healthcare facilities are currently conducting this research initiative in the urban area?

"Patients are being recruited to this study at the Atlanta Center for Medical Research in Georgia, Uptown Research Institute in Illinois, and Hassman Research Institute in New Jersey. An additional 5 medical centres across America are also involved." - 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.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top