Phase 2
Completed N=8
Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
Advanced Parkinson's Disease
Source: ClinicalTrials.gov NCT01479127 ↗
Enrolled (actual)
8
Serious AEs
7.1%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period — 7; 5; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period |
7; 5; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period |
4; 3; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period |
3; 0; 3; 0; 3; 0 | — |
| PRIMARY Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period |
0; 1; 2; 0; 0; 0 | — |
| PRIMARY Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period |
0; 4; 1; 0; 1; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Results During the ABT-SLV187 Treatment Period |
— | — |
| PRIMARY 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 | 0.074 |
| SECONDARY 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 |
-15.33; 0.00; 14.67; -15.33; 0.67 | 0.058 |
| SECONDARY Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment |
-1.02; 0.76; 1.02 | 0.574 |
| SECONDARY Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia |
0.00; 0.00; 0.40; 0.40; 1.00; 0.60 | 0.500 |
| SECONDARY Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores |
-0.60; 0.20; 0.60; -2.20; -1.40; 2.20 | 0.870 |
| SECONDARY 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 |
1.26; 10.00; -0.83; -8.33; 1.25; -5.00 | 0.636 |
| SECONDARY Modified Hoehn and Yahr Staging at Baseline and End of Treatment |
2.5; 3.0; 4.0; 4.0 | 1.000 |
| SECONDARY Schwab and England Activities of Daily Living Scale at Baseline and End of Treatment |
80.0; 80.0 | 0.125 |
| SECONDARY Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment |
0; 0; 0; 2; 3; 0 | — |
| SECONDARY Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187 |
3.0; 1.0; 7.8; 4.5; 11; 11 | — |
| SECONDARY 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 |
5.96; 4.38; 0.128; 0.273; 9.27; 11.7 | — |
| SECONDARY 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 |
28.4; 34.4; 0.94; 2.07; 88.3; 118 | — |
| SECONDARY AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 |
0.036; 0.032; 0.012; 0.008; 0.112; 0.113 | — |
| SECONDARY Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187 |
2.1; 0.38; 0.97; 0.78; 0.48; 0.35 | — |
| SECONDARY 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; 3.53 | — |
| SECONDARY Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period |
2; 0; 0; 0; 0; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01479127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.