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

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

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221657

Enrollment

Registered

2011-11-22

Start date

2011-11-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Parkinson's disease

Interventions

investigational material(s) Generic name etc : ABT-SLV187 INN of investigational material : Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational mater

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank criteria 2.Parkinson's disease stage corresponds to 4 or 5 in the OFF state according to the modified Hoehn & Yahr (H & Y) classification of disease severity 3.Levodopa-responsive and 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

Exclusion criteria: 1.Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism 2.Undergone surgery for the treatment of PD 3.Contraindications to levodopa 4.Subjects with any neurological deficit that may interfere with the study assessments

Design outcomes

Primary

Measure	Time frame
1.Incident of adverse events during the ABT-SLV187 treatment period 2.Change from baseline in clinical laboratory test during the ABT-SLV187 treatment period 3.Change from baseline in vital signs during the ABT-SLV187 treatment period 4.Change from baseline in electrocardiogram (ECG) parameters during the ABT-SLV187 treatment period	—

Secondary

Measure	Time frame
1.Change from baseline to the end of the ABT-SLV187 treatment period in Treatment Response Scale (I) 2.Change from baseline to the end of the ABT-SLV187 treatment period in Treatment Response Scale (II) 3.Change from baseline to the end of the ABT-SLV187 treatment period in Video Scoring of Unified Parkinson's Disease Rating Scale items 4.Change from baseline to the end of the ABT-SLV187 treatment period in Unified Parkinson's Disease Rating Scale total score and subscores 5.Change from baseline to the end of the ABT-SLV187 treatment period in mean daily "OFF" time on the Parkinson's Disease Diary Summary statistics including a 95% confidence interval, Change from baseline 6.Change from baseline to the end of the ABT-SLV187 treatment period in Japanese version of Parkinson's Disease Questionnaire 39 total score and domain scores 7.Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa during the ABT-SLV treatment period 8.Incidence of product quality complaints during the ABT-SLV treatment period	—

Measure

Time frame

1.Change from baseline to the end of the ABT-SLV187 treatment period in Treatment Response Scale (I) 2.Change from baseline to the end of the ABT-SLV187 treatment period in Treatment Response Scale (II) 3.Change from baseline to the end of the ABT-SLV187 treatment period in Video Scoring of Unified Parkinson's Disease Rating Scale items 4.Change from baseline to the end of the ABT-SLV187 treatment period in Unified Parkinson's Disease Rating Scale total score and subscores 5.Change from baseline to the end of the ABT-SLV187 treatment period in mean daily "OFF" time on the Parkinson's Disease Diary Summary statistics including a 95% confidence interval, Change from baseline 6.Change from baseline to the end of the ABT-SLV187 treatment period in Japanese version of Parkinson's Disease Questionnaire 39 total score and domain scores 7.Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa during the ABT-SLV treatment period 8.Incidence of product quality complaints during the ABT-SLV treatment period

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Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026