A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson*s disease

Phase 3

Completed

Conditions: 10028037
paralysis agitans
shaking palsy

Registration Number: NL-OMON55829

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

Adult male or female subjects, 30 years of age or older at the time of
screening, with a diagnosis of idiopathic PD that is levodopa-responsive

Exclusion Criteria

Subjects judged by the investigator to be adequately controlled by current
therapy, that don't have recognizable/identifiable Off and On states (motor
fluctuations), and have less than 2.5 hours of Off time per day.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Percentage of subjects with adverse events (AEs) and serious adverse events<br /><br>(SAEs) during the study<br /><br>2. Percentage of subjects with AEs of special interest (AESIs) during the study<br /><br>3. Percentage of subjects with numeric grade equal to or higher than 5 and<br /><br>percentage of subjects with letter grade equal to or higher than D on the<br /><br>Infusion Site Evaluation Scale at any time during the study<br /><br>4. Change in clinical laboratory test data from Baseline to end of study<br /><br>5. Change in vital sign measurements from Baseline to end of study<br /><br>6. Change in electrocardiograms (ECGs) from Baseline to end of study</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change from Baseline to end of study for the following:<br /><br>1. Average normalized daily Off time and On times as assessed by the PD<br /><br>Diary<br /><br>2. PD symptoms as assessed by the Movement Disorder Society-Unified Parkinson's<br /><br>Disease Rating Scale (MDS-UPDRS) Parts I-IV (or the UPDRS Parts I-V in<br /><br>countries where a validated translation of the MDS-UPDRS is not available)<br /><br>3. Sleep symptoms as assessed by the PD Sleep Scale-2 (PDSS-2)<br /><br>4. Quality of life as assessed by the PD Questionnaire-39 items (PDQ-39)<br /><br>5. Health-related quality of life as assessed by the EuroQol 5-dimensions<br /><br>questionnaire (EQ-5D-5L)</p><br>