A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

NCT03781167 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M15-7412018-002144-85
• Study Type: interventional
• Target: 244
• Locations: 13 countries
• Sites: 65

Brief Summary

The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD). This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's Disease (PD); ABBV-951; Levodopa/Carbidopa

Outcome Measures

Primary Outcomes (50)

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. 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. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

  From first dose of study drug until 30 days following last dose of study drug (up to 480 days)

• Number of Participants With Adverse Events of Special Interest

  Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug.

  From first dose of study drug until 30 days following last dose of study drug (up to 480 days)

• Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale

  Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria \> 2 or \> C was recorded as an adverse event (AE).

  Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52

• Hematocrit (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Hemoglobin (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Neutrophils (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Lymphocytes (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Monocytes (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Absolute Platelet Count (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Creatinine (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Sodium (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Potassium (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Calcium (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Uric Acid (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Albumin (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Glucose (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Magnesium (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Homocysteine (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, and 52

• Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, and 52

• Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, and 52

• pH (Urinalysis): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Specific Gravity (Urinalysis): Change From Baseline to End of Study

  Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

  Baseline, Weeks 6, 26, 39, and 52

• Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study

  Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.

  Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)

• Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study

  Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.

  Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)

• Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study

  Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.

  Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)

• Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study

  12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

  Baseline, Day 1 (postdose), Weeks 6 and 52

• Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study

  12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

  Baseline, Day 1 (postdose), Weeks 6 and 52

• Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study

  12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

  Baseline, Day 1 (postdose), Weeks 6 and 52

• Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study

  12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

  Baseline, Day 1 (postdose), Weeks 6 and 52

• Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study

  12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

  Baseline, Day 1 (postdose), Weeks 6 and 52

• Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study

  12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

  Baseline, Day 1 (postdose), Weeks 6 and 52

• Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study

  12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

  Baseline, Day 1 (postdose), Weeks 6 and 52

Secondary Outcomes (10)

• Average Daily Normalized "Off" Time: Change From Baseline to End of Study

  Baseline, Weeks 1, 6, 13, 26, 39, and 52

• Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study

  Baseline, Weeks 1, 6, 13, 26, 39, and 52

• Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study

  Baseline, Weeks 1, 6, 13, 26, 39, and 52

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study

  Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study

  Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52

Study Arms (2)

ABBV-951 Low Dose Subgroup

EXPERIMENTAL

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.

Drug: ABBV-951

ABBV-951 High Dose Subgroup

EXPERIMENTAL

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.

Drug: ABBV-951

Interventions

ABBV-951 DRUG

Solution for continuous subcutaneous infusion (CSCI)

Also known as: Foslevodopa/Foscarbidopa

ABBV-951 High Dose Subgroup; ABBV-951 Low Dose Subgroup

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive
• Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

You may not qualify if:

• Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study
• Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason

Sponsors & Collaborators

• AbbVie: lead

Study Sites (65)

University of Alabama at Birmingham - Main /ID# 207996

Birmingham, Alabama, 35233, United States

Location

Banner Sun Health Res Inst /ID# 208811

Sun City, Arizona, 85351, United States

Location

The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126

Fountain Valley, California, 92708, United States

Location

University of Colorado Hospital /ID# 207968

Aurora, Colorado, 80045, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677

Boca Raton, Florida, 33486, United States

Location

Northwestern University Feinberg School of Medicine /ID# 208812

Chicago, Illinois, 60611-2927, United States

Location

Indiana Clinical Research Cent /ID# 207952

Indianapolis, Indiana, 46202, United States

Location

Univ Kansas Med Ctr /ID# 208963

Kansas City, Kansas, 66160, United States

Location

University of Kentucky Chandler Medical Center /ID# 207603

Lexington, Kentucky, 40536, United States

Location

Massachusetts General Hospital /ID# 207993

Boston, Massachusetts, 02114, United States

Location

Health Partners /ID# 207950

Saint Paul, Minnesota, 55130-2400, United States

Location

University of Missouri /ID# 209043

Columbia, Missouri, 65203, United States

Location

Washington University-School of Medicine /ID# 207525

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center /ID# 207972

Lebanon, New Hampshire, 03756, United States

Location

Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 209784

Raleigh, North Carolina, 27612, United States

Location

Legacy Medical Group - Neurology /ID# 208031

Portland, Oregon, 97232-2003, United States

Location

Prisma Health Cancer Institute-Faris Road /ID# 207650

Greenville, South Carolina, 29605-4255, United States

Location

Neurology Consultants of Dallas - LBJ Fwy /ID# 207619

Dallas, Texas, 75243-1188, United States

Location

Baylor College of Medicine /ID# 207620

Houston, Texas, 77030-4202, United States

Location

Central Texas Neurology Consul /ID# 216918

Round Rock, Texas, 78681, United States

Location

Univ Texas HSC San Antonio /ID# 208958

San Antonio, Texas, 78229-3901, United States

Location

Booth Gardner Parkinson's Care Center /ID# 208026

Kirkland, Washington, 98034-3029, United States

Location

Inland Northwest Research /ID# 208122

Spokane, Washington, 99202-1342, United States

Location

Medical College of Wisconsin /ID# 207999

Milwaukee, Wisconsin, 53226-3522, United States

Location

Concord Repatriation General Hospital /ID# 207628

Concord, New South Wales, 2139, Australia

Location

Westmead Hospital /ID# 207633

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital /ID# 207634

Adelaide, South Australia, 5000, Australia

Location

Alfred Health /ID# 207632

Melbourne, Victoria, 3004, Australia

Location

Perron Institute /ID# 207627

Nedlands, Western Australia, 6009, Australia

Location

Universitair Ziekenhuis Leuven /ID# 209058

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Sint-Jan Brugge /ID# 208178

Bruges, 8000, Belgium

Location

Groupe Sante CHC - Clinique du MontLegia /ID# 208177

Liège, 4000, Belgium

Location

University of Calgary - Movement Disorders Clinic /ID# 207342

Calgary, Alberta, T2N 4N1, Canada

Location

Centre de Recherche St-Louis /ID# 207344

Québec, Quebec, G1W 4R4, Canada

Location

Bispebjerg and Frederiksberg Hospital /ID# 207669

Copenhagen NV, Capital Region, 2400, Denmark

Location

Aarhus University Hospital /ID# 207668

Aarhus N, Central Jutland, 8200, Denmark

Location

Odense University Hospital /ID# 207871

Odense C, Region Syddanmark, 5000, Denmark

Location

Universitaetsklinikum Ulm /ID# 208602

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Kliniken Beelitz GmbH /ID# 208600

Beelitz-Heilstätten, 14547, Germany

Location

InnKlinikum Haag /ID# 208601

Haag, 83527, Germany

Location

IRCCS Centro Neurolesi Bonino Pulejo /ID# 207975

Messina, 98124, Italy

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 207955

Milan, 20133, Italy

Location

Azienda Ospedaliera di Padova /ID# 208077

Padua, 35128, Italy

Location

National Hospital Organization Asahikawa Medical Center /ID# 210914

Asahikawa-shi, Hokkaido, 070-8644, Japan

Location

National Hospital Organization Utano National Hospital /ID# 210912

Kyoto, Kyoto, 616-8255, Japan

Location

Osaka University Hospital /ID# 210913

Suita-shi, Osaka, 565-0871, Japan

Location

Juntendo University Hospital /ID# 210915

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

National Center of Neurology and Psychiatry /ID# 210911

Kodaira-shi, Tokyo, 187-8551, Japan

Location

Erasmus Medisch Centrum /ID# 208168

Rotterdam, South Holland, 3015 GD, Netherlands

Location

St. Antonius Ziekenhuis /ID# 208529

Nieuwegein, 3435 CM, Netherlands

Location

Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 216303

Saint Petersburg, Sankt-Peterburg, 197101, Russia

Location

City Clinical Hospital #40 /ID# 216301

Sestroretsk, Sankt-Peterburg, 197706, Russia

Location

Hospital General Universitario de Elche /ID# 209777

Elche, Alicante, 03203, Spain

Location

Hospital Universitario de Bellvitge /ID# 209539

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario A Coruna - CHUAC /ID# 212147

A Coruña, 15006, Spain

Location

Hospital Santa Creu i Sant Pau /ID# 208240

Barcelona, 08041, Spain

Location

Hospital Universitario Virgen de las Nieves /ID# 208242

Granada, 18014, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 208241

Madrid, 28034, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 208239

Seville, 41013, Spain

Location

Skane University Hospital Lund /ID# 207811

Lund, Skåne County, SE 221 41, Sweden

Location

Centrum for neurologi /ID# 207716

Stockholm, Stockholm County, 113 65, Sweden

Location

Sahlgrenska University Hospital /ID# 207718

Gothenburg, Västra Götaland County, 413 46, Sweden

Location

NHS Tayside /ID# 209242

Dundee, Scotland, DD2 1UB, United Kingdom

Location

King's College Hospital NHS Foundation Trust /ID# 208413

London, SE5 9RS, United Kingdom

Location

University Hospital Plymouth NHS Trust /ID# 208447

Plymouth, PL6 5FP, United Kingdom

Location

Related Publications (3)

• Pahwa R, Aldred J, Soileau MJ, Standaert DG, Fung VSC, Kimber T, Malaty IA, Santos-Garcia D, Carroll C, Henriksen T, Parab A, Yan CH, Facheris MF, Spiegel A, Harmer L, Zamudio J, Chaudhuri KR. Improvement in Motor Consistency and Stability with Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease: Post Hoc Analysis of Two Phase 3 Clinical Trials. Neurol Ther. 2025 Dec;14(6):2491-2506. doi: 10.1007/s40120-025-00827-6. Epub 2025 Oct 4.

  PMID: 41045349 DERIVED

• Chaudhuri KR, Facheris MF, Bergmans B, Bergquist F, Criswell SR, Jia J, Kukreja P, Mukai Y, Spiegel AM, Gupta R, Bergmann L, Pahwa R. Improved Sleep Correlates with Improved Quality of Life and Motor Symptoms with Foslevodopa/Foscarbidopa. Mov Disord Clin Pract. 2024 Jul;11(7):861-866. doi: 10.1002/mdc3.14018. Epub 2024 Mar 11.

  PMID: 38465885 DERIVED

• Aldred J, Freire-Alvarez E, Amelin AV, Antonini A, Bergmans B, Bergquist F, Bouchard M, Budur K, Carroll C, Chaudhuri KR, Criswell SR, Danielsen EH, Gandor F, Jia J, Kimber TE, Mochizuki H, Robieson WZ, Spiegel AM, Standaert DG, Talapala S, Facheris MF, Fung VSC. Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. Neurol Ther. 2023 Dec;12(6):1937-1958. doi: 10.1007/s40120-023-00533-1. Epub 2023 Aug 26.

  PMID: 37632656 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: April 29, 2019
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

JP (5); GB (3); IT (3); CA (2); NL (2); US (24); RU (2); ES (7); AU (5); DK (3); BE (3); DE (3); SE (3)