Parkinson's Disease (PD)Phase 1NCT03374917
A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment
A Phase 1 study testing ABBV-951 in people with Parkinson's Disease (PD), run by AbbVie at 12 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD). Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson's Disease (PD)
- 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
- 20 participants
- Where
- 12 sitesUnited States
- Study dates
- 18 Apr 2018to 4 Mar 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with a diagnosis of definite idiopathic Parkinson's disease (PD) that is levodopa-responsive according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.
- Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before enrollment in this study.
- Subject is judged inadequately controlled on current therapy in the opinion of the Investigator and must experience a minimum of 2.5 hours of "off" time per day prior to Enrollment.
- Subjects with a MMSE score greater than or equal to 24 and considered by the Investigator to not have dementia.
Who cannot join
- Subjects with clinically significant electrocardiogram (ECG) values.
- History of significant skin conditions or disorders that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
- Receipt of an investigational product within at least 6 weeks prior to study drug administration.
- Subjects with moderate to severe kidney disease.
- Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.
- Patient/caregiver that cannot demonstrate proper use of the devices (drug pump and wearable device) will not be allowed to participate.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Cincinnati /ID# 165142
Cincinnati, Ohio, 45267-0585
Cleveland Clinic Foundation /ID# 164413
Cleveland, Ohio, 44195
Neurology Consultants of Dallas /ID# 167116
Dallas, Texas, 75251-3831
Univ Kansas Med Ctr /ID# 166280
Kansas City, Kansas, 66160
University of Kentucky Chandler Medical Center /ID# 164407
Lexington, Kentucky, 40536
Loma Linda University /ID# 165592
Loma Linda, California, 92354
University of Louisville /ID# 164997
Louisville, Kentucky, 40202
NYU Langone Medical Center /ID# 164924
New York, New York, 10016-6402
Univ CA, Irvine Med Ctr /ID# 165594
Orange, California, 92868
Compass Research /ID# 167329
Orlando, Florida, 32806
Washington University-School of Medicine /ID# 164412
St Louis, Missouri, 63110
Banner Sun Health Res Inst /ID# 165840
Sun City, Arizona, 85351
About this study
Official title: An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).
- Conditions
- Parkinson's Disease (PD)
- Being tested
- ABBV-951
- Keywords
- carbidopa, levodopa
- 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
powder for solution
| Study group | Role | What they receive |
|---|---|---|
| ABBV-951 | Experimental | ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks. Receives: Drug: ABBV-951 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Infusion Site Reactions
Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.
Measured: 28 Days
Number of Participants with Adverse Events
Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after discontinuation of study drug.
Measured: From first dose of study drug to 30 days after last dose of study drug (up to 2 months)
Percentage of Participants with Markedly Abnormal Vital Signs Values
Vital signs will be collected both supine and standing.
Measured: 28 days
Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an instrument designed to assess suicidal behavior and ideation.
Measured: 28 days
Percentage of Participants with Potentially Clinically Significant Laboratory Values
Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.
Measured: 28 days
Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results
A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.
Measured: 28 days
Secondary outcomes (1)
Plasma Concentrations of Levodopa
Blood samples for pharmacokinetic assessment will be collected twice at each visit.
Measured: Days 1, 7, 14, 21, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start18 Apr 2018
- Primary completion4 Mar 2019
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT03374917
- Sponsor's protocol ID
- M15-739
- Status last verified
- Nov 2024
- First submitted
- 8 Dec 2017
- Last updated
- 12 Nov 2024
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment
- ClinicalTrials.gov ID
- NCT03374917
- Acronym / sponsor ID
- M15-739
- Conditions
- Parkinson's Disease (PD)
- Keywords
- carbidopa, levodopa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 15 Dec 2017 (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.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABBV-951 | Experimental | Drug: ABBV-951ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject with a diagnosis of definite idiopathic Parkinson's disease (PD) that is levodopa-responsive according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.
- Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before enrollment in this study.
- Subject is judged inadequately controlled on current therapy in the opinion of the Investigator and must experience a minimum of 2.5 hours of "off" time per day prior to Enrollment.
- Subjects with a MMSE score greater than or equal to 24 and considered by the Investigator to not have dementia.
Key exclusion criteria (6 listed)
- Subjects with clinically significant electrocardiogram (ECG) values.
- History of significant skin conditions or disorders that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
- Receipt of an investigational product within at least 6 weeks prior to study drug administration.
- Subjects with moderate to severe kidney disease.
- Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.
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-951powder for solution | Drug | ABBV-951 |
Primary outcome
Percentage of Participants with Infusion Site Reactions
Time frame: 28 Days
Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.
Number of Participants with Adverse Events
Time frame: From first dose of study drug to 30 days after last dose of study drug (up to 2 months)
Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after discontinuation of study drug.
Percentage of Participants with Markedly Abnormal Vital Signs Values
Time frame: 28 days
Vital signs will be collected both supine and standing.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 28 days
The C-SSRS is an instrument designed to assess suicidal behavior and ideation.
Percentage of Participants with Potentially Clinically Significant Laboratory Values
Time frame: 28 days
Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.
Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results
Time frame: 28 days
A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.
1 secondary outcome
Plasma Concentrations of Levodopa
Time frame: Days 1, 7, 14, 21, and 28
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 12 Nov 2024.
- 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
12 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 (PD), run by AbbVie at 12 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 4 inclusion and 6 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Percentage of Participants with Infusion Site Reactions (time frame: 28 Days). The study lists 6 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 12 Nov 2024.