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

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 - M15-741

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55829

Enrollment

Registered

2019-03-27

Start date

2019-12-19

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paralysis agitans shaking palsy

Interventions

ABBV-951 solution for infusion

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Secondary

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

Measure

Time frame

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

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Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)