Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease [M15-737]

An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease [M15-737]

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225358

Enrollment

Registered

2020-08-26

Start date

2020-09-23

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Parkinson's Disease

Interventions

ABBV-951 - Solution for continuous subcutaneous infusion (CSCI) - Foscarbidopa/Foslevodopa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Participants who have Parkinson's Disease and who have successfully completed the parent study M15-741. - Participants willing and able to comply with procedures required in the protocol.

Exclusion criteria

Exclusion criteria: - Participants, if judged by the investigator to be unsuitable candidates to continue to receive ABBV-951 for any reason.

Design outcomes

Primary

Measure	Time frame
safety 1.Percentage of Participants With Adverse Events (AE) An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study drug or device as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Adverse Events of Special Interest (AESI) - polyneuropathy, weight loss, hallucinations/psychosis, and somnolence will be monitored throughout the study. [Time Frame: Up To Week 114] 2.Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site"). [Time Frame: Up To Week 114] 3.Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs"). [Time Frame: Up To Week 114] 4.Change in Clinical Laboratory Test Data Number of participants with clinically significant change from baseline in laboratory parameters (hem	—

Measure

Time frame

safety 1.Percentage of Participants With Adverse Events (AE) An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study drug or device as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Adverse Events of Special Interest (AESI) - polyneuropathy, weight loss, hallucinations/psychosis, and somnolence will be monitored throughout the study. [Time Frame: Up To Week 114] 2.Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site"). [Time Frame: Up To Week 114] 3.Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs"). [Time Frame: Up To Week 114] 4.Change in Clinical Laboratory Test Data Number of participants with clinically significant change from baseline in laboratory parameters (hem

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Secondary

Measure	Time frame
efficacy 7.Average Normalized Daily "Off" Time Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary. [Time Frame: Up To Week 114] 8.Average Normalized Daily "On" Time Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary. [Time Frame: Up To Week 114] 9.Parkinson's Disease (PD) Symptoms Measurement PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV. The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability. [Time Frame: Up To Week 114] 10.Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39) Quality of life is assessed by the PD Questionnaire-39 items (PDQ-39). PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. Each item is scored on a 5-point scale. [Time Frame: Up To Week 114] 11.Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions Questionnaire (EQ-5D-5L) Health-related quality of life is assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L). EQ-5D-5L is a standardized instrument that consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue-scale (EQVAS). [Time Frame: Up To Week 114] 12.Cognitive Impairment Measurement Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, wi	—

Measure

Time frame

efficacy 7.Average Normalized Daily "Off" Time Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary. [Time Frame: Up To Week 114] 8.Average Normalized Daily "On" Time Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary. [Time Frame: Up To Week 114] 9.Parkinson's Disease (PD) Symptoms Measurement PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV. The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability. [Time Frame: Up To Week 114] 10.Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39) Quality of life is assessed by the PD Questionnaire-39 items (PDQ-39). PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. Each item is scored on a 5-point scale. [Time Frame: Up To Week 114] 11.Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions Questionnaire (EQ-5D-5L) Health-related quality of life is assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L). EQ-5D-5L is a standardized instrument that consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue-scale (EQVAS). [Time Frame: Up To Week 114] 12.Cognitive Impairment Measurement Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, wi

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Countries

Europe, Japan, North America, Oceania

Contacts

Public ContactPatients and HCP Contact

AbbVie G.K

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026