Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LB-102 | Other | An open label study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LB-102 | Drug | LB-102 flexible dosing 50 mg - 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events. | Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate long term safety and tolerability | Evaluating the safety of treatment by number of adverse events | 52 weeks |
| Evaluate long term safety and tolerability | Evaluating the safety of treatment by change in vital signs, electrocardiogram (QTC), and weight/height for BMI |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Eramo, MD | Contact | 212-605-0300 | clinicaltrials@lbpharma.us | |
| Branislav Mancevski, MD | Contact | 212-605-0300 | clinicaltrials@lbpharma.us |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler Clinical Trials | Chandler | Arizona | 85224 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open label study
Not provided
Not provided
Not provided
Not provided
| 52 weeks |
| Evaluate long term safety and tolerability | Evaluating the safety of treatment by conducting physical examinations | 52 weeks |
| Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS) | Change in Positive and Negative Syndrome Scale (PANSS) from Baseline to end of treatment where a decrease in score likely indicate response to treatment whereas an increase in score may indicate a worsening of disease where an increase in the scale score may indicate a worsening of disease and decrease in score likely indicates response to treatment. | 52 weeks |
| Pillar Clinical Research | Bentonville | Arkansas | 72712 | United States |
|
| Pillar Clinical Research | Little Rock | Arkansas | 72204 | United States |
|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States |
|
| Advanced Research Center | Anaheim | California | 92805 | United States |
|
| Synapse Clinical Trials | Cerritos | California | 90703 | United States |
|
| ProScience Research Group | Culver City | California | 90230 | United States |
|
| CenExel | Culver City | California | 92845 | United States |
|
| Synergy San Diego | San Diego | California | 92064 | United States |
|
| CenExel | Hollywood | Florida | 33024 | United States |
|
| Segal Trials | Miami Lakes | Florida | 33063 | United States |
|
| Health Synergy Clinical Research | West Palm Beach | Florida | 33407 | United States |
|
| CenExel | Atlanta | Georgia | 30331 | United States |
|
| Accelerated Clinical Trial | Snellville | Georgia | 30078 | United States |
|
| Pillar Clinical Research | Chicago | Illinois | 60641 | United States |
|
| CenExel Gaithersburg | Gaithersburg | Maryland | 20877 | United States |
|
| Arch Clinical Trials | St Louis | Missouri | 63141 | United States |
|
| Redbird Research | Las Vegas | Nevada | 89119 | United States |
|
| Neuro-Behavioral Clinical Research | New York | New York | 11516 | United States |
|
| Neuro-Behavioral Clinical Research | Canton | Ohio | 44720 | United States |
|
| Adams Clinical | Philadelphia | Pennsylvania | 19104 | United States |
|
| Adams Clinical | DeSoto | Texas | 75115 | United States |
|
| Pillar Clinical Research | Richardson | Texas | 75080 | United States |
|
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided