Parkinson's DiseasePhase 1NCT05094050
Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease
A Phase 1 study testing ABBV-951 in people with Parkinson's Disease, run by AbbVie at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- ABBV-951
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Jan 2022to 17 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Colorado Hospital /ID# 229974
Aurora, Colorado, 80045
Parkinson Disease Movement Disorders Clinic /ID# 245791
Austin, Texas, 78746
Rush University Medical Center /ID# 229983
Chicago, Illinois, 60612
Texas Movement Disorder Specialists /ID# 238607
Georgetown, Texas, 78628-4126
Baylor College of Medicine - Baylor Medical Center /ID# 239631
Houston, Texas, 77030-3411
Vanderbilt University Medical Center /ID# 230255
Nashville, Tennessee, 37232-0011
Carolina Phase 1, LLC /ID# 239836
Raleigh, North Carolina, 27612-8106
University of Utah Health Care /ID# 241219
Salt Lake City, Utah, 84132
The Movement Disorder Clinic of Oklahoma /ID# 238610
Tulsa, Oklahoma, 74136-6378
Georgetown University Hospital /ID# 230224
Washington D.C., District of Columbia, 20007
About this study
Official title: Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients
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.
Read more
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.
- Conditions
- Parkinson's Disease
- Being tested
- ABBV-951
- Keywords
- Parkinson's Disease, Foslevodopa/foscarbidopa, ABBV-951, Levodopa (LD), Carbidopa (CD)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-951Drug
Also called Foslevodopa/foscarbidopa
Continuous Subcutaneous Infusion (CSCI)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: ABBV-951 | Experimental | Participants will receive ABBV-951 for 2 consecutive days in the abdomen (Period 1), flank (Period 2), arm (Period 3) and thigh (Period 4). Receives: Drug: ABBV-951 |
| Arm 2: ABBV-951 | Experimental | Participants will receive ABBV-951 for 2 consecutive days in the arm (Period 1), abdomen (Period 2), thigh (Period 3) and flank (Period 4). Receives: Drug: ABBV-951 |
| Arm 3: ABBV-951 | Experimental | Participants will receive ABBV-951 for 2 consecutive days in the thigh (Period 1), arm (Period 2), flank (Period 3) and abdomen (Period 4). Receives: Drug: ABBV-951 |
| Arm 4: ABBV-951 | Experimental | Participants will receive ABBV-951 for 2 consecutive days in the flank (Period 1), thigh (Period 2), abdomen (Period 3) and arm (Period 4). Receives: Drug: ABBV-951 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD)
Maximum observed plasma concentration (Cmax) of Levodopa (LD).
Measured: Up to 8 Days
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD
Area under the plasma concentration-time curve (AUC) for the 24-hour interval of LD.
Measured: Up to 8 Days
Minimum Observed Plasma Concentration (Cmin) of LD
Minimum observed plasma concentration (Cmin) of LD.
Measured: Up to 8 Days
Degree of Fluctuation (DFL) of LD
DFL = (Cmax-Cmin)/(average plasma concentration).
Measured: Up to 8 Days
Swing of LD
Swing = (Cmax-Cmin)/Cmin.
Measured: Up to 8 Days
Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD)
Maximum observed plasma concentration (Cmax) of CD.
Measured: Up to 8 Days
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD
Area under the plasma concentration-time curve (AUC) for the 24-hour interval of CD.
Measured: Up to 8 Days
Minimum Observed Plasma Concentration (Cmin) of CD
Minimum observed plasma concentration (Cmin) of CD.
Measured: Up to 8 Days
Degree of Fluctuation (DFL) of CD
DFL = (Cmax-Cmin)/(average plasma concentration).
Measured: Up to 8 Days
Swing of CD
Swing = (Cmax-Cmin)/Cmin.
Measured: Up to 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start18 Jan 2022
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094050
- Sponsor's protocol ID
- M20-339
- Status last verified
- Mar 2023
- First submitted
- 20 Oct 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT05094050
- Acronym / sponsor ID
- M20-339
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Foslevodopa/foscarbidopa, ABBV-951, Levodopa (LD), Carbidopa (CD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: ABBV-951 | Experimental | Drug: ABBV-951Participants will receive ABBV-951 for 2 consecutive days in the abdomen (Period 1), flank (Period 2), arm (Period 3) and thigh (Period 4). |
| Arm 2: ABBV-951 | Experimental | Drug: ABBV-951Participants will receive ABBV-951 for 2 consecutive days in the arm (Period 1), abdomen (Period 2), thigh (Period 3) and flank (Period 4). |
| Arm 3: ABBV-951 | Experimental | Drug: ABBV-951Participants will receive ABBV-951 for 2 consecutive days in the thigh (Period 1), arm (Period 2), flank (Period 3) and abdomen (Period 4). |
| Arm 4: ABBV-951 | Experimental | Drug: ABBV-951Participants will receive ABBV-951 for 2 consecutive days in the flank (Period 1), thigh (Period 2), abdomen (Period 3) and arm (Period 4). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-951Also: Foslevodopa/foscarbidopaContinuous Subcutaneous Infusion (CSCI) | Drug | Arm 1: ABBV-951, Arm 2: ABBV-951, Arm 3: ABBV-951, Arm 4: ABBV-951 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD)
Time frame: 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
Time frame: 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
Time frame: Up to 8 Days
Minimum observed plasma concentration (Cmin) of LD.
Degree of Fluctuation (DFL) of LD
Time frame: Up to 8 Days
DFL = (Cmax-Cmin)/(average plasma concentration).
Swing of LD
Time frame: Up to 8 Days
Swing = (Cmax-Cmin)/Cmin.
Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD)
Time frame: 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
Time frame: 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
Time frame: Up to 8 Days
Minimum observed plasma concentration (Cmin) of CD.
Degree of Fluctuation (DFL) of CD
Time frame: Up to 8 Days
DFL = (Cmax-Cmin)/(average plasma concentration).
Swing of CD
Time frame: Up to 8 Days
Swing = (Cmax-Cmin)/Cmin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-951 in people with Parkinson's Disease, run by AbbVie at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD) (time frame: Up to 8 Days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.