Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.

• Register: EUCTR
• Last refreshed on: 8 July 2024
• Main ID: EUCTR2019-004235-23-DK
• Date of registration: 22/06/2020
• Prospective Registration: Yes
• Primary sponsor: Abbvie Deutschland GmbH & Co. KG
• Public title: Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.
• Scientific title: 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.
• Date of first enrolment: 18/11/2020
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-004235-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, Denmark, Germany, Italy, Japan, Netherlands, Russian Federation, Sweden, United Kingdom, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject must be able to understand the nature of the study and have had the opportunity to have any questions answered by the investigator.
2. Subject, if judged by the investigator to have decision making capacity, must voluntarily sign and date an informed consent form approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to initiation of any study-specific procedures.
3. Subject completed ABBV-951 Study M15-741 (parent study).
4. Subject is willing and able to comply with procedures required in this protocol.
5. Subject is not considered by the investigator to be an unsuitable candidate to continue to receive ABBV-951 for any reason.
6. Subject confirms to not have suicidal ideation (as evidenced by answering "no" to Questions 4 or 5 on the suicidal ideation portion of the C-SSRS) at the Final Visit of the parent study.
7. If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least 1 protocol-specified method of birth control that is effective from D1 through at least 30 days after the end of the infusion of study drug. Subject is not pregnant, breastfeeding, or considering becoming pregnant or donating eggs during the study or within 30 days after the end of the infusion of study drug. If female of childbearing potential, subject must have a negative urine pregnancy test on D1.
8. If male and sexually active with a female partner(s) of childbearing potential, subject must agree to practice protocol-specified contraception. Subject is not considering fathering a child or donating sperm during the study or within 30 days after the end of the infusion of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion criteria:
1. Subject has received an investigational product other than ABBV-951 within a time period equal to 5 half-lives, if known, or within 6 weeks, whichever is longer, prior to study drug administration.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Parkinson's Disease
MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Foslevodopa
Current Sponsor code: A-1591706.0
Other descriptive name: Levodopa-4'-Monophosphate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 240-
INN or Proposed INN: Foscarbidopa
Current Sponsor code: A-1610308.0
Other descriptive name: Carbidopa-4'-Monophosphate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 12.0-

Primary Outcome(s)

Main Objective: To assess the local and systemic safety and tolerability of continued
ABBV-951 treatment delivered as a CSCI for 24 hours daily.

Secondary Objective: N/A

Primary end point(s): 1. Percentage of subjects with adverse events (AEs) and 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 the end of study
5. Change in vital sign measurements from Baseline to the end of study
6. Change in electrocardiograms (ECGs) from Baseline to the end of study

Timepoint(s) of evaluation of this end point: 1. At each remote assessment and clinic visit.
2. At each remote assessment and clinic visit
3. Collected at each clinic visit
4. Collected at each clinic visit
5. Collected at each clinic visit
6. Collected at each clinic visit

Secondary Outcome(s)

Secondary end point(s): Change from Baseline to the 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
3. Quality of life as assessed by the PD Questionnaire-39 items (PDQ-39)
4. Health-related quality of life as assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L)
5. Cognitive impairment as assessed by the Mini-Mental State Examination (MMSE)

Timepoint(s) of evaluation of this end point: All secondary endpoints are collected at each clinic visit.

Secondary ID(s)

2019-004235-23-NL

M15-737

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 18/11/2020
Contact: