Clinical trial NCT01479127: Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
Official title: An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Parkinson's Disease
Keywords: Levodopa-carbidopa intestinal gel
Advanced Parkinson's disease
Severe motor fluctuations
Dyskinesia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Abbott Japan Co.,Ltd
First posted: 2011-11-24
Enrollment: 8
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the safety, tolerability, pharmacokinetics and efficacy of ABT-SLV187 in advanced Parkinson's disease (PD) patients with severe motor complications. The complications of medical devices for the naso-jejunum (NJ) infusion system of ABT-SLV187 will also be investigated.


Eligibility criteria: Inclusion Criteria:

* Idiopathic PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank criteria
* PD stage corresponds to 4 or 5 in the 'off' state according to the modified Hoehn \& Yahr (H \& Y) classification of disease severity
* Levodopa-responsive subjects demonstrate some identifiable 'ON response' established by observation by Investigator and demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
* Undergone surgery for the treatment of PD
* Contraindications to levodopa
* Subjects with any neurological deficit that may interfere with the study assessments

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period
timeFrame: During the Run-in period (up to approximately 28 days)
measure: Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period
timeFrame: From NJ placement to end of ABT-SLV187 Treatment Period (Day 21) +30 days
measure: Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Results During the ABT-SLV187 Treatment Period
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the "Normal" State on the Treatment Response Scale (TRS) I
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Secondary outcomes:
measure: 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
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia
timeFrame: Baseline (Day -1), Endpoint (Day 21)
measure: Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: 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
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Modified Hoehn and Yahr Staging at Baseline and End of Treatment
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Schwab and England Activities of Daily Living Scale at Baseline and End of Treatment
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187
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.
measure: 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
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: 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
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: 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
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
measure: Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period
timeFrame: Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Japan Co., Ltd
name: Yukihiro Kumamoto, MS
role: STUDY_DIRECTOR
References: