Clinical trial

An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease

Name

M20-098

Description

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia. Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.

Trial arms

Trial start

2021-02-18

Estimated PCD

2025-05-16

Trial end

2025-05-16

Status

Active (not recruiting)

Phase

Early phase I

Treatment

ABBV-951

Solution for continuous subcutaneous infusion (CSCI).

Arms:

ABBV-951

Other names:

Foscarbidopa, Foslevodopa

Size

118

Primary endpoint

Percentage of Participants with Adverse Event (AEs)

Up to Week 96

Percentage of Participants with AEs of Special Interest (AESIs)

Up to Week 96

Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale

Up To Week 96

Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale

Up To Week 96

Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Up To Week 96

Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)

Up To Week 96

Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)

Up To Week 96

Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.

Up to Week 96

Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed

Up to Week 96

Change From Baseline in Electrocardiograms (ECGs)

Up to Week 96

Eligibility criteria

Inclusion Criteria: - Completion of the parent study, Study M15-736 or Study M20-339. Exclusion Criteria: - Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 118, 'type': 'ACTUAL'}}

Updated at

2023-09-06

1 organization

1 product

1 indication

Product

ABBV-951

Indication

Parkinson's Disease

Organization

AbbVie