Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Foslevodopa/foscarbidopa, ABBV-951, Levodopa (LD), Carbidopa (CD)
Brief summary
Parkinson's disease (PD) is a neurological condition, which means it affects the brain. This study will evaluate how ABBV-951 is absorbed under the skin of participants with PD when administered to arm, thigh and flank compared to the abdomen. ABBV-951 is an investigational drug being developed for the treatment of PD. Study doctors randomly assign participants to 1 of 4 groups, called treatment arms. Each treatment arm receives ABBV-951 administered in a different order in the arm, high, flank and abdomen. Approximately 12 adult participants over 30 years with a diagnosis of PD will be enrolled in approximately 10 sites in the United States. Participants will receive continuous (24hours/day) subcutaneous infusion of ABBV-951 for 2 consecutive days for each infusion site (arm, thigh, flank and abdomen), for a total duration of treatment up to 12 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will be confined at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Adverse events will be monitored throughout the study.
Interventions
DRUGABBV-951
Continuous Subcutaneous Infusion (CSCI)
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic Parkinson's disease (PD) that is Levodopa-responsive. * Must be taking a minimum of 400 mg/day of levodopa equivalents (LE) and be judged by the investigator to have motor symptoms inadequately controlled by current therapy. * Must have recognizable/identifiable Off and On states (motor fluctuations), and have a minimum daily average of 2.5 hours of Off time (with a minimum of 2 hours of Off time each day).
Exclusion criteria
\- History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD) | Up to 8 Days | Maximum observed plasma concentration (Cmax) of Levodopa (LD). |
| Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD | Up to 8 Days | Area under the plasma concentration-time curve (AUC) for the 24-hour interval of LD. |
| Minimum Observed Plasma Concentration (Cmin) of LD | Up to 8 Days | Minimum observed plasma concentration (Cmin) of LD. |
| Degree of Fluctuation (DFL) of LD | Up to 8 Days | DFL = (Cmax-Cmin)/(average plasma concentration). |
| Swing of LD | Up to 8 Days | Swing = (Cmax-Cmin)/Cmin. |
| Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD) | Up to 8 Days | Maximum observed plasma concentration (Cmax) of CD. |
| Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD | Up to 8 Days | Area under the plasma concentration-time curve (AUC) for the 24-hour interval of CD. |
| Minimum Observed Plasma Concentration (Cmin) of CD | Up to 8 Days | Minimum observed plasma concentration (Cmin) of CD. |
| Degree of Fluctuation (DFL) of CD | Up to 8 Days | DFL = (Cmax-Cmin)/(average plasma concentration). |
| Swing of CD | Up to 8 Days | Swing = (Cmax-Cmin)/Cmin. |
Countries
United States
Outcome results
None listed