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
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-951 | Experimental | ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-951 | Drug | powder for solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Infusion Site Reactions | Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale. | 28 Days |
| Number of Participants with Adverse Events | Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after discontinuation of study drug. | From first dose of study drug to 30 days after last dose of study drug (up to 2 months) |
| Percentage of Participants with Markedly Abnormal Vital Signs Values | Vital signs will be collected both supine and standing. | 28 days |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is an instrument designed to assess suicidal behavior and ideation. | 28 days |
| Percentage of Participants with Potentially Clinically Significant Laboratory Values | Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast. | 28 days |
| Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results | A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of Levodopa | Blood samples for pharmacokinetic assessment will be collected twice at each visit. | Days 1, 7, 14, 21, and 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Sun Health Res Inst /ID# 165840 | Sun City | Arizona | 85351 | United States | ||
| Loma Linda University /ID# 165592 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Loma Linda |
| California |
| 92354 |
| United States |
| Univ CA, Irvine Med Ctr /ID# 165594 | Orange | California | 92868 | United States |
| Compass Research /ID# 167329 | Orlando | Florida | 32806 | United States |
| Univ Kansas Med Ctr /ID# 166280 | Kansas City | Kansas | 66160 | United States |
| University of Kentucky Chandler Medical Center /ID# 164407 | Lexington | Kentucky | 40536 | United States |
| University of Louisville /ID# 164997 | Louisville | Kentucky | 40202 | United States |
| Washington University-School of Medicine /ID# 164412 | St Louis | Missouri | 63110 | United States |
| NYU Langone Medical Center /ID# 164924 | New York | New York | 10016-6402 | United States |
| University of Cincinnati /ID# 165142 | Cincinnati | Ohio | 45267-0585 | United States |
| Cleveland Clinic Foundation /ID# 164413 | Cleveland | Ohio | 44195 | United States |
| Neurology Consultants of Dallas /ID# 167116 | Dallas | Texas | 75251-3831 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided