A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03374917|
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease (PD)||Drug: ABBV-951||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment|
|Actual Study Start Date :||April 18, 2018|
|Estimated Primary Completion Date :||February 25, 2019|
|Estimated Study Completion Date :||February 25, 2019|
ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks.
powder for solution
- Percentage of Participants with Infusion Site Reactions [ Time Frame: 28 Days ]Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.
- Number of Participants with Adverse Events [ Time Frame: From first dose of study drug to 30 days after last dose of study drug (up to 2 months) ]Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after discontinuation of study drug.
- Percentage of Participants with Markedly Abnormal Vital Signs Values [ Time Frame: 28 days ]Vital signs will be collected both supine and standing.
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 28 days ]The C-SSRS is an instrument designed to assess suicidal behavior and ideation.
- Percentage of Participants with Potentially Clinically Significant Laboratory Values [ Time Frame: 28 days ]Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.
- Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results [ Time Frame: 28 days ]A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.
- Plasma Concentrations of Levodopa [ Time Frame: Days 1, 7, 14, 21, and 28 ]Blood samples for pharmacokinetic assessment will be collected twice at each visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374917
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|United States, Arizona|
|Banner Sun Health Res Inst /ID# 165840||Recruiting|
|Sun City, Arizona, United States, 85351|
|United States, California|
|Loma Linda University /ID# 165592||Recruiting|
|Loma Linda, California, United States, 92354|
|Univ CA, Irvine Med Ctr /ID# 165594||Not yet recruiting|
|Orange, California, United States, 92868|
|United States, Florida|
|Compass Research /ID# 167329||Recruiting|
|Orlando, Florida, United States, 32806|
|United States, Kansas|
|Univ Kansas Med Ctr /ID# 166280||Recruiting|
|Kansas City, Kansas, United States, 66160|
|United States, Kentucky|
|University of Kentucky Chandler Medical Center /ID# 164407||Recruiting|
|Lexington, Kentucky, United States, 40536|
|University of Louisville /ID# 164997||Not yet recruiting|
|Louisville, Kentucky, United States, 40202|
|United States, Missouri|
|Washington University-School of Medicine /ID# 164412||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|NYU Langone Medical Center /ID# 164924||Recruiting|
|New York, New York, United States, 10016-6402|
|United States, Ohio|
|University of Cincinnati /ID# 165142||Not yet recruiting|
|Cincinnati, Ohio, United States, 45267-0585|
|Cleveland Clinic Foundation /ID# 164413||Recruiting|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|Neurology Consultants of Dallas /ID# 167116||Recruiting|
|Dallas, Texas, United States, 75231-3831|
|Study Director:||AbbVie Inc.||AbbVie|