Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT04750226

Acronym / sponsor ID

M20-098

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's Disease, PD, ABBV-951, Levodopa/Carbidopa (LD/CD), Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

118 participants (actual)

Lead sponsor

AbbVieIndustry (pharma, biotech, devices)

Study start

18 Feb 2021 (actual)

Primary completion

27 Apr 2026 (actual)

Study completion

27 Apr 2026 (actual)

First posted

11 Feb 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.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

30 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Percentage of Participants with Adverse Event (AEs)

   Time frame: Up to Week 96

   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 this treatment. An 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above.

2. Percentage of Participants with AEs of Special Interest (AESIs)

   Time frame: Up to Week 96

   AESIs are defined as AEs from "special situations," such as accidental or intentional overdose, medication error, occupational or accidental exposure, off-label use, drug abuse, drug misuse, or drug withdrawal, all which must be reported whether associated with an AE or not.

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

   Time frame: Up To Week 96

   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").

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

   Time frame: Up To Week 96

   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").

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

   Time frame: Up To Week 96

   C-SSRS is a systematically administered instrument designed to assess suicidal behavior and ideation, track and assess all suicidal events, and assess the lethality of attempts. Any participant who has suicidal behavior or suicidal ideation with plan since the last C-SSRS completed, will be evaluated immediately by the investigator.

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

   Time frame: Up To Week 96

   The QUIP-RS is a brief, self-completed or rater-administered rating scale to assess the severity of symptoms of impulse control disorders (ICDs) and related behaviors reported to occur in PD. The QUIP-RS uses a 5-point Likert scale that requires individuals to rate the severity of each symptom based on its frequency.

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

   Time frame: Up To Week 96

   Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is a brief 30-point questionnaire, administered by a trained rater, that provides a quantitative measure of cognitive status in adults and is used widely to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time, to follow the course of changes in a patient over time, and to document response to treatment.

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

   Time frame: Up to Week 96

   Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed..

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

   Time frame: 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.

10. Change From Baseline in Electrocardiograms (ECGs)

    Time frame: Up to Week 96

    12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.

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 1 Jun 2026.
• Derived from this study: PubMed 40402298Soileau M, Kumar R, Parab A, Brion T, White K, Yan CH, Shah MB, Kukreja P, Facheris MF, Shewale A, Aldred J. Patients' experience with and perspectives on long-term use of continuous subcutaneous infusion of foslevodopa/foscarbidopa in Parkinson's disease. J Neurol. 2025 May 22;272(6):416. doi: 10.1007/s00415-025-13123-y.
• Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Related trials for Parkinson's Disease (PD)

• Active, not recruitingPhase 1/2

  Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease

  Parkinson Disease (PD)

• Active, not recruitingObservational study

  Adaptive DBS to Offset STN Dysregulation During Exercise in PD

  Parkinson Disease

• Not yet recruiting

  Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.

  Stroke, Parkinson's Disease (PD)

• RecruitingObservational study

  Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation

  Parkinson Disease

• Not yet recruiting

  Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.

  Parkinson Disease

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.

52 sites in 2 countries: see every site and its status.