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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004235-23 | EudraCT Number |
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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. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741.
ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide.
Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily 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 clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-951 | Experimental | Participants will receive ABBV-951 solution by continuous subcutaneous infusion (CSCI), at the discretion of the investigator, for up to 96 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-951 | Drug | Solution for continuous subcutaneous infusion (CSCI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AE) | 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 the treatment. The investigator assesses the relationship of each event to the use of the study drug or device as either reasonable possibility or no reasonable possibility. A serious adverse event (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 participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Adverse Events of Special Interest (AESI) - polyneuropathy, weight loss, hallucinations/psychosis, and somnolence will be monitored throughout the study. | Up To Week 96 |
| Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale | 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"). | Up To Week 96 |
| Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale | 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"). | Up To Week 96 |
| Change in Clinical Laboratory Test Data | Number of participants with clinically significant change from baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis) will be reported throughout the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Normalized Daily "Off" Time | Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary. | Up To Week 96 |
| Average Normalized Daily "On" Time | Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary. |
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Inclusion Criteria:
Exclusion Criteria:
- Participants, if judged by the investigator to be unsuitable candidates to continue to receive ABBV-951 for any reason.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 215597 | Birmingham | Alabama | 35233 | United States | ||
| Banner Sun Health Research Institute /ID# 215579 |
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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Up To Week 96 |
| Change in Vital Signs Measurements | Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study. | Up To Week 96 |
| Change From Baseline in Electrocardiograms (ECGs) | Change from baseline in 12-lead ECGs on heart rate, RR interval, PR interval, QRS duration, and QT interval will be monitored throughout the study. | Up To Week 96 |
| Up To Week 96 |
| Parkinson's Disease (PD) Symptoms Measurement | PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV. The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability. | Up To Week 96 |
| Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39) | Quality of life is assessed by the PD Questionnaire-39 items (PDQ-39). PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. Each item is scored on a 5-point scale. | Up To Week 96 |
| Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L) | Health-related quality of life is assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L). EQ-5D-5L is a standardized instrument that consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue-scale (EQVAS). | Up To Week 96 |
| Cognitive Impairment Measurement | Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function. | Up To Week 96 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| University of Colorado Hospital /ID# 215625 | Aurora | Colorado | 80045 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 215412 | Boca Raton | Florida | 33486 | United States |
| Indiana Clinical Research Cent /ID# 216490 | Indianapolis | Indiana | 46202 | United States |
| Univ Kansas Med Ctr /ID# 215624 | Kansas City | Kansas | 66160 | United States |
| Washington University-School of Medicine /ID# 215472 | St Louis | Missouri | 63110 | United States |
| Dartmouth-Hitchcock Medical Center /ID# 216834 | Lebanon | New Hampshire | 03756 | United States |
| M3 Wake Research - Raleigh /ID# 215596 | Raleigh | North Carolina | 27612-8106 | United States |
| Legacy Medical Group - Neurology /ID# 215536 | Portland | Oregon | 97232-2003 | United States |
| Baylor College of Medicine /ID# 215401 | Houston | Texas | 77030 | United States |
| Central Texas Neurology Consul /ID# 217013 | Round Rock | Texas | 78681 | United States |
| Univ Texas HSC San Antonio /ID# 215400 | San Antonio | Texas | 78229-3901 | United States |
| Booth Gardner Parkinson's Care Center /ID# 215535 | Kirkland | Washington | 98034-3029 | United States |
| Inland Northwest Research /ID# 215533 | Spokane | Washington | 99202-1342 | United States |
| Concord Repatriation General Hospital /ID# 215943 | Concord | New South Wales | 2139 | Australia |
| Westmead Hospital /ID# 215941 | Westmead | New South Wales | 2145 | Australia |
| Duplicate_Royal Adelaide Hospital /ID# 215940 | Adelaide | South Australia | 5000 | Australia |
| The Alfred Hospital /ID# 215942 | Melbourne | Victoria | 3004 | Australia |
| Perron Institute /ID# 215944 | Nedlands | Western Australia | 6009 | Australia |
| Universitair Ziekenhuis Leuven /ID# 215684 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Duplicate_Algemeen Ziekenhuis Sint-Jan Brugge /ID# 215686 | Bruges | West-Vlaanderen | 8000 | Belgium |
| Duplicate_Groupe Sante CHC - Clinique du MontLegia /ID# 215685 | Liège | 4000 | Belgium |
| University of Calgary /ID# 215369 | Calgary | Alberta | T2N 4Z6 | Canada |
| Clinique Neuro Levis /ID# 215371 | Lévis | Quebec | G6W 0M5 | Canada |
| Bispebjerg and Frederiksberg Hospital /ID# 215391 | Copenhagen NV | Capital Region | 2400 | Denmark |
| Aarhus Universitetshospital - Skejby /ID# 215392 | Aarhus | Central Jutland | 8200 | Denmark |
| Odense University Hospital /ID# 215390 | Odense | Region Syddanmark | 5000 | Denmark |
| Universitaetsklinikum Ulm /ID# 215405 | Ulm | Baden-Wurttemberg | 89081 | Germany |
| curiositas ad sanum /ID# 215404 | Haag i.OB | Bavaria | 83527 | Germany |
| Kliniken Beelitz GmbH /ID# 215403 | Beelitz-Heilstätten | 14547 | Germany |
| IRCCS Centro Neurolesi Bonino Pulejo /ID# 215422 | Messina | 98124 | Italy |
| Azienda Ospedale-Universita Padova /ID# 215421 | Padova | 35128 | Italy |
| National Hospital Organization Asahikawa Medical Center /ID# 218762 | Asahikawa-shi | Hokkaido | 070-8644 | Japan |
| Duplicate_Osaka University Hospital /ID# 217415 | Suita-shi | Osaka | 565-0871 | Japan |
| National Center of Neurology and Psychiatry /ID# 218763 | Kodaira-shi | Tokyo | 187-8551 | Japan |
| St. Antonius Ziekenhuis, Locatie Utrecht /ID# 215396 | Utrecht | 3543 AZ | Netherlands |
| Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 218869 | Saint Petersburg | Sankt-Peterburg | 197101 | Russia |
| City Clinical Hospital #40 /ID# 218870 | Sestroretsk | Sankt-Peterburg | 197706 | Russia |
| Complejo Hospitalario Universitario A Coruña /ID# 215426 | A Coruña | A Coruna | 15006 | Spain |
| Hospital General Universitario de Elche /ID# 215425 | Elche | Alicante | 03203 | Spain |
| Hospital Universitari de Bellvitge /ID# 215427 | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Santa Creu i Sant Pau /ID# 215429 | Barcelona | 08041 | Spain |
| Hospital Universitario Virgen de las Nieves /ID# 215431 | Granada | 18014 | Spain |
| Hospital Universitario Virgen del Rocio /ID# 215428 | Seville | 41013 | Spain |
| Skane University Hospital Lund /ID# 215385 | Lund | Skåne County | 224 84 | Sweden |
| Karolinska Universitetssjukhuset - Huddinge /ID# 215386 | Huddinge | Stockholm County | 141 57 | Sweden |
| Sahlgrenska Universitetssjukhuset /ID# 215387 | Gothenburg | Västra Götaland County | 413 46 | Sweden |
| Derriford Hospital and the Royal Eye Infirmary /ID# 217390 | Plymouth | Devon | PL6 8DH | United Kingdom |
| Kings College Hospital NHS Foundation Trust /ID# 217388 | London | Greater London | SE5 9RS | United Kingdom |
| NHS Tayside /ID# 217389 | Dundee | Scotland | DD2 1UB | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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