Trial Outcomes & Findings for Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease (NCT NCT01479127)

Last Updated: 2016-04-21

Results Overview

AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

During the Run-in period (up to approximately 28 days)

Results posted on

2016-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Levodopa-carbidopa Intestinal Gel Following a 28-day Run-in Period where participants are switched from prior anti-Parkinson's disease (PD) medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel \[LCIG\]), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Overall Study STARTED	8
Overall Study Started LCIG	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levodopa-carbidopa Intestinal Gel n=8 Participants Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Age, Continuous	65.4 years STANDARD_DEVIATION 6.19 • n=5 Participants
Age, Customized < 65 years	4 participants n=5 Participants
Age, Customized >/= 65 years	4 participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the Run-in period (up to approximately 28 days)

Population: Full safety sample: participants who had at least one dose of oral levodopa-carbidopa study drug in the Run-in Period.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=8 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period AE	7 participants	—
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period AE at least possibly related to study drug/device	5 participants	—
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period Severe AE	0 participants	—
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period SAE	0 participants	—
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period AE leading to discontinuation of study drug	1 participants	—
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period SAE at least possibly drug or drug device-related	0 participants	—
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period AE of special interest	0 participants	—
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period AE caused by study drug	5 participants	—
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period AE caused by devices	NA participants Not applicable to Run-in Period.	—
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period AE caused by NJ tube insertion	NA participants Not applicable to Run-in Period.	—
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period Fatal AE	0 participants	—

PRIMARY outcome

Timeframe: From NJ placement to end of ABT-SLV187 Treatment Period (Day 21) +30 days

Population: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=6 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period AE	4 participants	—
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period AE at least possibly related to study drug/device	3 participants	—
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period Severe AE	1 participants	—
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period SAE	1 participants	—
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period AE leading to discontinuation of study drug	1 participants	—
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period SAE at least possiby drug or drug device-related	1 participants	—
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period AE of special interest	2 participants	—
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period AE caused by study drug	3 participants	—
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period AE caused by devices	0 participants	—
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period AE caused by NJ tube insertion	1 participants	—
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period Fatal AE	0 participants	—

PRIMARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

M=male, F=female, MCV=mean corpuscular volume, MCH=mean corpuscular hemoglobin, MCHC=mean corpuscular hemoglobin concentration.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=6 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS Hematocrit [%]: 39.8 M / 33.4 F	3 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS Hematocrit [%]: 51.8 M / 44.9 F	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS Hemoglobin [g/dL]: 13.5 M / 11.3 F	3 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS Hemoglobin [g/dL]: 17.6 M / 15.2 F	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS RBC Count [*10^4/µL]: 427 M / 376 F	3 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS RBC Count [*10^4/µL]: 570 M / 500 F	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS WBC Count [/µL]: 3900 M / 3500 F	1 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS WBC Count [/µL]: 9800 M / 9100 F	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS Neutrophils [%]: 40.0	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS Neutrophils [%]: 74.0	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS Lymphocytes [%]: 18.0	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS Lymphocytes [%]: 59.0	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS Monocytes [%]: 0.0	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS Monocytes [%]: 8.0	1 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS Basophils [%]: 0.0	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS Basophils [%]: 2.0	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS Eosinophils [%]: 0.0	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS Eosinophils [%]: 6.0	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS Platelet count [*10^4/µL]: 13.1 M / 13.0 F	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS Platelet count [*10^4/µL]: 36.2 M/ 36.9 F	1 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS MCV [FL]: 82.7 M / 79.0 F	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS MCV [FL]: 101.6 M / 100.0 F	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS MCH [Pg]: 28 M / 26.3 F	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS MCH [Pg]: 34.6 M / 34.3 F	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period Low PCS MCHC [%]: 31.6 M / 30.7 F	1 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period High PCS MCHC [%]: 36.6 M / 36.6 F	0 participants	—

PRIMARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

M=male, F=female, γ-GTP=gamma-glutamyl transpeptidase.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=6 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Blood urea nitrogen [mg/dL]: 6	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Blood urea nitrogen [mg/dL]: 20	1 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low Creatinine [mg/dL]: 0.61 M / 0.47 F	2 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High Creatinine [mg/dL]: 1.04 M / 0.79 F	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Total bilirubin [mg/dL]: 0.2	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Total bilirubin [mg/dL]: 1.0	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Alanine aminotransferase [U/L]: 5	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Alanine aminotransferase [U/L]: 40	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Aspartate aminotransferase [U/L]: 10	1 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Aspartate aminotransferase [U/L]: 40	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Alkaline phosphatase [U/L]: 115	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Alkaline phosphatase [U/L]: 359	1 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS γ-GTP [U/L]: 0	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS γ-GTP [U/L]: 70 M / 30 F	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Sodium [mEq/L]: 136	1 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Sodium [mEq/L]: 147	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Potassium [mEq/L]: 3.6	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Potassium [mEq/L]: 5.0	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Calcium [mg/dL]: 8.7	3 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Calcium [mg/dL]: 10.1	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Chloride [mEq/L]: 98	1 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Chloride [mEq/L]: 109	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Magnesium [mg/dL]: 1.8	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Magnesium [mg/dL]: 2.6	1 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Inorganic Phosphors [mg/dL]: 2.4	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Inorganic Phosphors [mg/dL]: 4.3	1 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Uric acid [mg/dL]: 3.7 M / 2.5 F	2 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Uric acid [mg/dL]: 7 M / 7.0 F	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Total cholesterol [mg/dL]: 150	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Total cholesterol [mg/dL]: 219	2 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Total protein [g/dL]: 6.7	5 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Total protein [g/dL]: 8.3	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Albumin [g/dL]: 4.0	3 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Albumin [g/dL]: 5.0	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Glucose [mg/dL]: 70	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Glucose [mg/dL]: 109	1 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Triglycerides [mg/dL]: 50	1 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Triglycerides [mg/dL]: 149	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Creatine kinase [U/L]: 57 M / 32 F	1 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Creatine kinase [U/L]: 197 M / 180 F	3 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Bicarbonate [mEq/L]: 22	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Bicarbonate [mEq/L]: 29	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period Low PCS Lactate dehydrogenase [U/L]: 115	0 participants	—
Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period High PCS Lactate dehydrogenase [U/L]: 245	1 participants	—

PRIMARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

M=male, F=female

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=6 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period Low PCS Vitamin B6 pyridoxamine [ng/mL]: </= 0.6	0 participants	—
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period Low PCS Vitamin B6 pyridoxal [ng/mL]: 6.0 M/4.0 F	4 participants	—
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period High PCS Vitamin B6 pyridoxal [ng/mL]: 40 M / 19 F	1 participants	—
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period Low PCS Vitamin B6 pyridoxine [ng/mL]: </= 3.0	0 participants	—
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period Low PCS Vitamin B12 [pg/mL]: 180	1 participants	—
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period High PCS Vitamin B12 [pg/mL]: 914	0 participants	—
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period Low PCS Homocysteine [nmol/mL]: 3.7	0 participants	—
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period High PCS Homocysteine [nmol/mL]: 13.5	4 participants	—
Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period Low PCS Folic acid [ng/mL]: < 3.1	1 participants	—

PRIMARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=6 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period High PCS Specific gravity: 1.030	0 participants	—
Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period Low PCS Specific gravity: 1.002	0 participants	—
Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period Low PCS pH: 4.5	0 participants	—
Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period High PCS pH: 8.0	1 participants	—
Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period High PCS Protein: > trace	0 participants	—
Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period High PCS Glucose: > trace	0 participants	—
Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period High PCS Occult blood: > negative	0 participants	—
Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period High PCS Ketone: > negative	0 participants	—

PRIMARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

↓=decrease, ↑=increase, BL=baseline, temp.=temperature, SBP=systolic blood pressure, Sup.=supine, Sta.=standing, DBP=diastolic blood pressure.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=6 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period Low PCS Weight [kg]: ≥7% ↓ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period High PCS Weight [kg]: ≥7% ↑ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period High PCS Body temp. [⁰C]: ≥38.8 and ≥1.1 ↑ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period Low PCS SBP Sup. [mmHg]: ≤90 and >30 ↓ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period High PCS SBP Sup. [mmHg]: ≥180 and >40 ↑ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period Low PCS SBP Sta. [mmHg]: ≤90 and >30 ↓ from BL	1 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period High PCS SBP Sta. [mmHg]: ≥180 and >40 ↑ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period Low PCS SBP Orthostatic [mmHg]: ↓ of ≥30 in SBP	1 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period Low PCS DBP Sup. [mmHg]: ≤50 and >30 ↓ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period High PCS DBP Sup. [mmHg]: ≥105 and >30 ↑ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period Low PCS DBP Sta. [mmHg]: ≤50 and >30 ↓ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period High PCS DBP Sta. [mmHg]: ≥105 and >30 ↑ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period Low PCS DBP Orthostatic [mmHg]: ↓ of ≥20 in DBP	1 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period Pulse rate [bpm]: ≤50 and >30 ↓ from BL	0 participants	—
Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period Pulse rate [bpm]: ≥120 and >30 ↑ from BL	0 participants	—

PRIMARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

High potentially clinically significant Bazett's heart rate-corrected QT interval (QTcB) values were: 450 msec for males / 470 msec for females.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=6 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Results During the ABT-SLV187 Treatment Period	0 participants	—

PRIMARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.

Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and Treatment Response Scale (TRS) under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia. The average of the neurologists' evaluations was calculated as a percentage of ratings in the "Normal" state (ie, "mild OFF" to "ON with mild dyskinesia") on the TRS I (total 10 assessments per day).

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "Normal" State on the Treatment Response Scale (TRS) I	15.33 percentage of ratings Standard Deviation 14.26	—

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.

Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and TRS under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia for TRS I, with the addition of Tremor at Rest and Postural Stability for TRS II. The average of the 3 neurologists' evaluations was calculated as a percentage of ratings in the "Normal" state (ie, "mild OFF" to "ON with mild dyskinesia"), the "Off" state ("moderate OFF" to "severe OFF"), and the "Dyskinesia" state ("ON with moderate dyskinesia" to "ON with severe dyskinesia") on the TRS I or II.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "OFF" and "Dyskinesia" States on the TRS I and the "Normal," "OFF," and "Dyskinesia" States on the TRS II TRS I "OFF" state	-15.33 percentage of ratings Standard Deviation 13.04	—
Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "OFF" and "Dyskinesia" States on the TRS I and the "Normal," "OFF," and "Dyskinesia" States on the TRS II TRS I "Dyskinesia" state	0.00 percentage of ratings Standard Deviation 4.71	—
Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "OFF" and "Dyskinesia" States on the TRS I and the "Normal," "OFF," and "Dyskinesia" States on the TRS II TRS II "Normal" state	14.67 percentage of ratings Standard Deviation 18.65	—
Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "OFF" and "Dyskinesia" States on the TRS I and the "Normal," "OFF," and "Dyskinesia" States on the TRS II TRS II "OFF" state	-15.33 percentage of ratings Standard Deviation 18.65	—
Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "OFF" and "Dyskinesia" States on the TRS I and the "Normal," "OFF," and "Dyskinesia" States on the TRS II TRS II "Dyskinesia" state	0.67 percentage of ratings Standard Deviation 1.49	—

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.

For each half hour period during 3 consecutive days prior to each assessment of the diary, participants (and/or their caregivers) entered into a diary whether they were asleep, in the ON motor state or in the OFF motor state in the following 5 grades: asleep, OFF, ON (no dyskinesia \[D\]), ON with non-troublesome dyskinesia (NTD), ON with troublesome dyskinesia (TD). ON time is when PD symptoms are well controlled by the drug. OFF time is when PD symptoms are not adequately controlled by the drug. Dyskinetic time is time with involuntary muscle movement. The ON or OFF times were calculated as the average of 3 daily times from the diaries. w/o = without, w/ = with

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment Daily OFF time	-1.02 hours Standard Deviation 3.73	—
Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment Daily ON time w/o D + time w/ NTD	0.76 hours Standard Deviation 3.61	—
Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment Daily ON time w/o D + time w/ NTD + time w/ TD	1.02 hours Standard Deviation 3.73	—

SECONDARY outcome

Timeframe: Baseline (Day -1), Endpoint (Day 21)

Population: Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.

Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the video under blinded conditions using the following assessments: Tremor at Rest (UPDRS item #20), Finger Taps (UPDRS #23), Rapid Alternating Movement of Hands (UPDRS #25), Arising from Chair (UPDRS #27), Gait (UPDRS #29), Postural Stability (UPDRS #30), Body Bradykinesia and Hypokinesia (UPDRS #31), and Dyskinesia (evaluated with the Goetz Dyskinesia Rating Scale). The UPDRS score is the sum of the answers to individual questions, each of which are measured on a 5-point scale (0-4), with higher scores associated with more disability. The Goetz Dyskinesia Rating Scale is a 5-point scale of the severity of dyskinesias, from 0 (absent) to 4 (violent dyskinesias).

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Tremor at rest, Baseline	0.00 units on a scale Standard Deviation 0.00	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Tremor at rest, Endpoint	0.00 units on a scale Standard Deviation 0.00	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Finger taps, Baseline	0.40 units on a scale Standard Deviation 0.55	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Finger taps, Endpoint	0.40 units on a scale Standard Deviation 0.55	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Rapid alternating movement of hands, Baseline	1.00 units on a scale Standard Deviation 0.00	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Rapid alternating movement of hands, Endpoint	0.60 units on a scale Standard Deviation 0.55	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Arising from chair, Baseline	0.10 units on a scale Standard Deviation 0.22	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Arising from chair, Endpoint	0.00 units on a scale Standard Deviation 0.00	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Gait, Baseline	0.60 units on a scale Standard Deviation 0.55	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Gait, Endpoint	0.60 units on a scale Standard Deviation 0.55	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Postural stability, Baseline	1.60 units on a scale Standard Deviation 0.55	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Postural stability, Endpoint	1.10 units on a scale Standard Deviation 0.89	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Body bradykinesia and hypokinesia, Baseline	1.00 units on a scale Standard Deviation 0.00	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Body bradykinesia and hypokinesia, Endpoint	0.80 units on a scale Standard Deviation 0.27	—
Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia Dyskinesia, Baseline	0.90 units on a scale Standard Deviation 0.55	—

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score ranges from 0-176, with 176 representing the worst (total) disability, and 0 no disability. The Part I Score is the sum of the answers to the 4 questions related to Mentation, Behavior and Mood, and ranges from 0-16. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. The Part IV Score is the sum of the answers to the 11 questions related to Complications of Therapy, and ranges from 0-23. The Part IV dyskinesia subscore ranges from 0-12. For each part of the UPDRS, higher scores are associated with more disability.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores Total score	-0.60 units on a scale Standard Deviation 7.70	—
Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores Part I	0.20 units on a scale Standard Deviation 0.45	—
Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores Part II	0.60 units on a scale Standard Deviation 4.93	—
Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores Part II (Off-time)	-2.20 units on a scale Standard Deviation 6.54	—
Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores Part III	-1.40 units on a scale Standard Deviation 4.56	—
Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores Part IV subscore of dyskinesia	2.20 units on a scale Standard Deviation 2.39	—

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients, including Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort, as well as a Summary Index Total Score. Scores for each are on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores Total score	1.26 units on a scale Standard Deviation 5.48	—
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores Domain: Mobility	10.00 units on a scale Standard Deviation 20.16	—
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores Domain: Activities of daily living	-0.83 units on a scale Standard Deviation 14.25	—
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores Domain: Emotional well-being	-8.33 units on a scale Standard Deviation 12.84	—
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores Domain: Stigma	1.25 units on a scale Standard Deviation 10.27	—
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores Domain: Social support	-5.00 units on a scale Standard Deviation 6.85	—
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores Domain: Cognition	-5.00 units on a scale Standard Deviation 13.55	—
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores Domain: Communication	1.67 units on a scale Standard Deviation 20.75	—
Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores Domain: Bodily discomfort	8.33 units on a scale Standard Deviation 30.62	—

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.

Participant's ON and OFF states staged according to the Modified Hoehn and Yahr criteria, an 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. ON time is when PD symptoms are well controlled by the drug. OFF time is when PD symptoms are not adequately controlled by the drug.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Modified Hoehn and Yahr Staging at Baseline and End of Treatment ON state staging, Baseline	2.5 units on a scale Interval 2.5 to 3.0	—
Modified Hoehn and Yahr Staging at Baseline and End of Treatment ON state staging, Endpoint	3.0 units on a scale Interval 2.0 to 3.0	—
Modified Hoehn and Yahr Staging at Baseline and End of Treatment OFF state staging, Baseline	4.0 units on a scale Interval 4.0 to 4.0	—
Modified Hoehn and Yahr Staging at Baseline and End of Treatment OFF state staging, Endpoint	4.0 units on a scale Interval 2.0 to 4.0	—

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.

The Schwab and England scale was used to rate the subject's activities of daily living by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%).

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Schwab and England Activities of Daily Living Scale at Baseline and End of Treatment Endpoint	80.0 units on a scale Interval 70.0 to 90.0	—
Schwab and England Activities of Daily Living Scale at Baseline and End of Treatment Baseline	80.0 units on a scale Interval 50.0 to 80.0	—

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.

The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Baseline: Normal	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Baseline: Borderline ill	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Baseline: Mildly ill	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Baseline: Moderately ill	2 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Baseline: Markedly ill	3 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Baseline: Severely ill	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Baseline: Among the most extremely ill	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Endpoint: Normal	1 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Endpoint: Borderline ill	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Endpoint: Mildly ill	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Endpoint: Moderately ill	3 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Endpoint: Markedly ill	1 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Endpoint: Severely ill	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-S, Endpoint: Among the most extremely ill	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-I: Very much improved	1 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-I: Much improved	3 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-I: Minimally improved	1 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-I: No change	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-I: Minimally worse	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-I: Much worse	0 participants	—
Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment CGI-I: Very much worse	0 participants	—

SECONDARY outcome

Timeframe: Baseline (Day -1): pre-dose; 15, 30, 45, 60 mins post-morning dose; every 30 mins thereafter for 12 hrs. Day 21: pre-dose; 15, 30, 45, 60 mins post-infusion; every 30 mins from hrs 1 to 12 post-infusion; every 2 hrs from 12 to 16 hrs post-infusion.

Population: Pharmacokinetic (PK) sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.

Tmax of levodopa, carbidopa, and its metabolite 3-O-methyldopa (3-OMD) after administration of oral L/C tablets and intra-jejunal administration of ABT-SLV187.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel n=5 Participants Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187 Levodopa	3.0 hours Standard Deviation 3.5	1.0 hours Standard Deviation 0.50
Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187 Carbidopa	7.8 hours Standard Deviation 2.8	4.5 hours Standard Deviation 4.2
Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187 3-OMD	11 hours Standard Deviation 0.76	11 hours Standard Deviation 0.79

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.

Cmax, Cavg, Cmin, and Cmin (2-12 hours) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). Cmin values for levodopa and carbidopa during the 16 hours of infusion were observed either at time 0 or 15 min after start of the infusion and were a result of drug washout prior to establishment of infusion.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel n=5 Participants Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cmax: Levodopa	5.96 µg/mL Standard Deviation 0.77	4.38 µg/mL Standard Deviation 1.15
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cmax: Carbidopa	0.128 µg/mL Standard Deviation 0.03	0.273 µg/mL Standard Deviation 0.07
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cmax: 3-OMD	9.27 µg/mL Standard Deviation 2.17	11.7 µg/mL Standard Deviation 1.25
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cavg: Levodopa	2.37 µg/mL Standard Deviation 0.26	2.87 µg/mL Standard Deviation 0.66
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cavg: Carbidopa	0.079 µg/mL Standard Deviation 0.02	0.172 µg/mL Standard Deviation 0.04
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cavg: 3-OMD	7.36 µg/mL Standard Deviation 1.93	9.80 µg/mL Standard Deviation 1.23
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cmin: Levodopa	0.268 µg/mL Standard Deviation 0.43	0.061 µg/mL Standard Deviation 0.03
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cmin: Carbidopa	0.014 µg/mL Standard Deviation 0.02	0.016 µg/mL Standard Deviation 0.01
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cmin: 3-OMD	5.67 µg/mL Standard Deviation 1.60	7.78 µg/mL Standard Deviation 0.63
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cmin (2-12 hours): Levodopa	0.734 µg/mL Standard Deviation 0.43	2.38 µg/mL Standard Deviation 0.77
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cmin (2-12 hours):Carbidopa	0.050 µg/mL Standard Deviation 0.02	0.130 µg/mL Standard Deviation 0.04
Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Cmin (2-12 hours): 3-OMD	5.72 µg/mL Standard Deviation 1.53	8.14 µg/mL Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.

AUC0-12 and AUC0-16 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel n=5 Participants Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-12: Levodopa	28.4 µg*h/mL Standard Deviation 3.08	34.4 µg*h/mL Standard Deviation 7.95
The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-12: Carbidopa	0.94 µg*h/mL Standard Deviation 0.18	2.07 µg*h/mL Standard Deviation 0.52
The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-12: 3-OMD	88.3 µg*h/mL Standard Deviation 23.1	118 µg*h/mL Standard Deviation 14.7
The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-16: Levodopa	NA µg*h/mL Standard Deviation NA AUC0-16 for oral levodopa-carbidopa tablets was not assessed.	46.7 µg*h/mL Standard Deviation 10.7
The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-16: Carbidopa	NA µg*h/mL Standard Deviation NA AUC0-16 for oral levodopa-carbidopa tablets was not assessed.	2.80 µg*h/mL Standard Deviation 0.666
The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-16: 3-OMD	NA µg*h/mL Standard Deviation NA AUC0-16 for oral levodopa-carbidopa tablets was not assessed.	165 µg*h/mL Standard Deviation 21.2

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.

AUC0-12/Dose0-12 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). AUC0-16/Dose0-16 of levodopa, carbidopa, and 3-OMD after administration of intra-jejunal administration of ABT-SLV187 (Day 21).

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel n=5 Participants Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-12/Dose0-12: 3-OMD	0.112 µg*h/mL/mg Standard Deviation 0.029	0.113 µg*h/mL/mg Standard Deviation 0.022
AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-16/Dose0-16: Levodopa	NA µg*h/mL/mg Standard Deviation NA AUC0-16/Dose0-16 not applicable after administration of the oral L/C tablets (Day -1).	0.035 µg*h/mL/mg Standard Deviation 0.007
AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-12/Dose0-12: Levodopa	0.036 µg*h/mL/mg Standard Deviation 0.008	0.032 µg*h/mL/mg Standard Deviation 0.006
AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-12/Dose0-12: Carbidopa	0.012 µg*h/mL/mg Standard Deviation 0.003	0.008 µg*h/mL/mg Standard Deviation 0.001
AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-16/Dose0-16: Carbidopa	NA µg*h/mL/mg Standard Deviation NA AUC0-16/Dose0-16 not applicable after administration of the oral L/C tablets (Day -1).	0.008 µg*h/mL/mg Standard Deviation 0.001
AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 AUC0-16/Dose0-16: 3-OMD	NA µg*h/mL/mg Standard Deviation NA AUC0-16/Dose0-16 not applicable after administration of the oral L/C tablets (Day -1).	0.125 µg*h/mL/mg Standard Deviation 0.025

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.

Degree of Fluctuation (calculated as \[Cmax - Cmin\] / Cavg)) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel n=5 Participants Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Levodopa	2.1 ratio Standard Deviation 0.59	0.38 ratio Standard Deviation 0.16
Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 Carbidopa	0.97 ratio Standard Deviation 0.20	0.78 ratio Standard Deviation 0.25
Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 3-OMD	0.48 ratio Standard Deviation 0.10	0.35 ratio Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.

M/P (AUC0-12) after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=5 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel n=5 Participants Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Ratio of Metabolite 3-OMD to Levodopa (M/P [AUC0-12]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187	3.11 ratio Standard Deviation 0.71	3.53 ratio Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)

Population: ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.

Outcome measures

Outcome measures
Measure	Oral Levodopa/Carbidopa Tablet n=6 Participants During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)	Levodopa-carbidopa Intestinal Gel Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period Any PQC	2 participants	—
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period Any PQC related to an AE	0 participants	—
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period Any serious PQC	0 participants	—
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period Any PQC leading to discontinuation of study drug	0 participants	—
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period Any PQC by pump	0 participants	—
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period Any PQC by NJ-tube insertion	2 participants	—
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period Any PQC by adapter	0 participants	—
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period Any PQC by cassettes	1 participants	—
Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period Without any PQCs	4 participants	—

Adverse Events

Oral Levodopa-carbidopa Tablets

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Levodopa-carbidopa Intestinal Gel

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Levodopa-carbidopa Tablets n=8 participants at risk A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).	Levodopa-carbidopa Intestinal Gel n=6 participants at risk Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Psychiatric disorders Somatic hallucination	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Psychiatric disorders Delusion	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Psychiatric disorders Hallucination, auditory	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).

Other adverse events

Additional Information

Global Medical Information

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	Oral Levodopa-carbidopa Tablets n=8 participants at risk A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).	Levodopa-carbidopa Intestinal Gel n=6 participants at risk Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks. The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Gastrointestinal disorders Constipation	37.5% 3/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Gastrointestinal disorders Nausea	25.0% 2/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Gastrointestinal disorders Stomatitis	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Gastrointestinal disorders Vomiting	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
General disorders Intentional medical device removal by patient	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
General disorders Malaise	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
General disorders Pain	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
General disorders Thirst	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Infections and infestations Otitis externa	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Injury, poisoning and procedural complications Contusion	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Injury, poisoning and procedural complications Excoriation	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Injury, poisoning and procedural complications Fall	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	33.3% 2/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Injury, poisoning and procedural complications Tooth fracture	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Musculoskeletal and connective tissue disorders Neck pain	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Nervous system disorders Amnesia	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Nervous system disorders Dizziness	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Nervous system disorders Dyskinesia	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	33.3% 2/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Nervous system disorders Hypoaesthesia	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Nervous system disorders ON and OFF phenomenon	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Nervous system disorders Parkinson's disease	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Psychiatric disorders Anxiety	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Psychiatric disorders Depressed mood	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Psychiatric disorders Hallucination	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Psychiatric disorders Insomnia	37.5% 3/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Psychiatric disorders Rapid eye movements sleep abnormal	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	0.00% 0/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).
Vascular disorders Orthostatic hypotension	12.5% 1/8 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).	16.7% 1/6 • AEs: from the time of first study drug administration in the Run-in Period to 30 days following completion or discontinuation of study drug administration (up to 79 days). SAEs from the time of Screening (up to 93 days).