52-week Open Label Safety-Tolerability Study
Purpose
Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia
Condition
- Schizophrenia
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Provide ICF - Patients clinically stable PANSS </= 70 at screening - CGI-S </+ 3 at screening - Medically stable - BMI 18 -40 - Taking oral antipsychotic treatment for at least 30 days - Have stable living environment
Exclusion Criteria
- Sexually active M/F patients not willing to use highly effective contraception - Breast feeding - History of treatment resistance to schizophrenia medications - DSM-5 current diagnosis other than schizophrenia - Risk of suicidal behavior - History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open label study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other LB-102 |
An open label study |
|
Recruiting Locations
Chandler Clinical Trials
Chandler, Arizona 85224
Chandler, Arizona 85224
Pillar Clinical Research
Bentonville, Arkansas 72712
Bentonville, Arkansas 72712
Pillar Clinical Research
Little Rock, Arkansas 72204
Little Rock, Arkansas 72204
Woodland International Research Group
Little Rock, Arkansas 72211
Little Rock, Arkansas 72211
Advanced Research Center
Anaheim, California 92805
Anaheim, California 92805
Synapse Clinical Trials
Cerritos, California 90703
Cerritos, California 90703
ProScience Research Group
Culver City, California 90230
Culver City, California 90230
Synergy San Diego
San Diego, California 92064
San Diego, California 92064
Health Synergy Clinical Research
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
Accelerated Clinical Trial
Snellville, Georgia 30078
Snellville, Georgia 30078
Pillar Clinical Research
Chicago, Illinois 60641
Chicago, Illinois 60641
CenExel Gaithersburg
Gaithersburg, Maryland 20877
Gaithersburg, Maryland 20877
Arch Clinical Trials
St Louis, Missouri 63141
St Louis, Missouri 63141
Redbird Research
Las Vegas, Nevada 89119
Las Vegas, Nevada 89119
Neuro-Behavioral Clinical Research
New York, New York 11516
New York, New York 11516
Neuro-Behavioral Clinical Research
Canton, Ohio 44720
Canton, Ohio 44720
Adams Clinical
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Adams Clinical
DeSoto, Texas 75115
DeSoto, Texas 75115
Pillar Clinical Research
Richardson, Texas 75080
Richardson, Texas 75080
More Details
- Status
- Recruiting
- Sponsor
- LB Pharmaceuticals Inc.
Detailed Description
Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia who are experiencing inadequate response or who are having issues with side effects, general tolerability, or overall effectiveness of their current antipsychotic medication and desire to change medications, or who have completed their participation in current LB-102 clinical studies