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

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease

ClinicalTrials.gov ID

NCT03781167

Acronym / sponsor ID

M15-741

Conditions

Parkinson's Disease (PD)

Keywords

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

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

244 participants (actual)

Lead sponsor

AbbVieIndustry (pharma, biotech, devices)

Study start

29 Apr 2019 (actual)

Primary completion

17 Aug 2022 (actual)

Study completion

17 Aug 2022 (actual)

First posted

19 Dec 2018 (actual)

Results

Posted 23 Oct 2023

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

Non-randomised

Intervention model

Single group

Masking

None (open label)

Number of arms

2

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. Number of Participants With Adverse Events

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

   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.

2. Number of Participants With Adverse Events of Special Interest

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

   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.

3. 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

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

   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).

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

   Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

   Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

   Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

   Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

   Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

   Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

    Time frame: Baseline, Weeks 6, 26, 39, and 52

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

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

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

    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.

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

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

    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.

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

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

    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.

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

    Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52

    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.

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

    Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52

    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.

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

    Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52

    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.

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

    Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52

    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.

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

    Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52

    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.

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

    Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52

    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.

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

    Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52

    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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 41984314Henriksen T, Martinez-Castrillo JC, Huisman MHB, Dhanani S, Peckham E, Aldred J, Bergmann L, Shah MB, Gupta R, Kukreja P, Parra JC, Fung VSC. Foslevodopa/Foscarbidopa Subcutaneous Infusion Safety and Efficacy in Patients with and Without Prior Deep Brain Stimulation. Adv Ther. 2026 Jun;43(6):2736-2751. doi: 10.1007/s12325-026-03579-3. Epub 2026 Apr 15.
• Derived from this study: PubMed 41045349Pahwa 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.
• Derived from this study: PubMed 38465885Chaudhuri 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.
• Derived from this study: PubMed 37632656Aldred 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.
• Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

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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.

65 sites in 13 countries: see every site and its status.