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

This study has been completed.
Sponsor:
Collaborator:
Abbott Japan Co.,Ltd
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01479127
First received: September 26, 2011
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Advanced Parkinson�s Disease
Drug: ABT-SLV187
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Incident of adverse events during the ABT-SLV187 treatment period [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Number of subjects with treatment-emergent adverse events by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term overall and by severity and relationship to study drug. Number of subjects with serious adverse events and with adverse events leading to discontinuation by MedDRA system organ class and preferred term.

  • Change from baseline in clinical laboratory test during the ABT-SLV187 treatment period [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Mean and mean change from baseline in hematology, clinical chemistry, urinalysis variables and scatoscopy

  • Change from baseline in vital signs during the ABT-SLV187 treatment period [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Mean and mean changes from baseline in blood pressure, pulse rate, body weight, body temperature and ECG parameters

  • Change from baseline in electrocardiogram (ECG) parameters during the ABT-SLV187 treatment period [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Mean and mean changes from baseline in ECG parameters


Secondary Outcome Measures:
  • Change from baseline to the end of the ABT-SLV187 treatment period in Treatment Response Scale (I) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Summary statistics including a 95% confidence interval, Change from baseline

  • Change from baseline to the end of the ABT-SLV187 treatment period in Treatment Response Scale (II) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Summary statistics including a 95% confidence interval, Change from baseline

  • Change from baseline to the end of the ABT-SLV187 treatment period in Video Scoring of Unified Parkinson's Disease Rating Scale items [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Summary statistics including a 95% confidence interval, Change from baseline

  • Change from baseline to the end of the ABT-SLV187 treatment period in mean daily "OFF" time on the Parkinson's Disease Diary [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Summary statistics including a 95% confidence interval, Change from baseline

  • Change from baseline to the end of the ABT-SLV187 treatment period in Unified Parkinson's Disease Rating Scale total score and subscores [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Summary statistics including a 95% confidence interval, Change from baseline

  • 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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Summary statistics including a 95% confidence interval, Change from baseline

  • Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa during the ABT-SLV treatment period [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Maximum plasma concentration (Cmax), time of Cmax (Tmax), area under the plasma concentration-time curve (AUC), minimum observed plasma concentration (Cmin), average plasma concentration (Cav)

  • Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa during the oral levodopa-carbidopa run-in period [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Maximum plasma concentration (Cmax), time of Cmax (Tmax), area under the plasma concentration-time curve (AUC), minimum observed plasma concentration (Cmin), average plasma concentration (Cav)

  • Incidence of product quality complaints during the ABT-SLV treatment period [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Frequency of product quality complaints


Enrollment: 6
Study Start Date: October 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levodopa-carbidopa intestinal gel
Usually 2-6 ml/hour (40-120 mg levodopa/hour), dose will be individually optimized for each subject based on the subject's symptoms
Drug: ABT-SLV187
IV, See Arm Description section
Other Name: ABT-SLV187, Duodopa

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank criteria
  • 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
  • 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

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479127

Locations
Japan
Site Reference ID/Investigator# 56425
Ehime, Japan
Site Reference ID/Investigator# 72033
Kyoto, Japan
Site Reference ID/Investigator# 56422
Tokyo, Japan
Site Reference ID/Investigator# 56423
Tokyo, Japan
Site Reference ID/Investigator# 56424
Wakayama, Japan
Sponsors and Collaborators
Abbott
Abbott Japan Co.,Ltd
Investigators
Study Director: Yukihiro Kumamoto, MS Abbott Japan Co.,Ltd
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01479127     History of Changes
Other Study ID Numbers: M12-925
Study First Received: September 26, 2011
Last Updated: September 17, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Advanced Parkinson's Disease
Severe motor fluctuations
Dyskinesia
Levodopa-carbidopa intestinal gel

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 20, 2014