Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
NCT ID: NCT01479127
Last Updated: 2016-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
8 participants
INTERVENTIONAL
2011-10-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Levodopa-carbidopa intestinal gel
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 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.
ABT-SLV187
Oral Levodopa/Carbidopa
Tablet; contains 100 mg levodopa and 10 mg carbidopa
Infusion Pump: CADD-Legacy® 1400 Pump
General infusion pump, manufactured by Smiths Medical (US)
NJ-Tube: Silicon ED Tube
Device used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan)
Adaptor: Hakko Adaptor
Accessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)
Interventions
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ABT-SLV187
Oral Levodopa/Carbidopa
Tablet; contains 100 mg levodopa and 10 mg carbidopa
Infusion Pump: CADD-Legacy® 1400 Pump
General infusion pump, manufactured by Smiths Medical (US)
NJ-Tube: Silicon ED Tube
Device used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan)
Adaptor: Hakko Adaptor
Accessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* Undergone surgery for the treatment of PD
* Contraindications to levodopa
* Subjects with any neurological deficit that may interfere with the study assessments
30 Years
99 Years
ALL
No
Sponsors
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Abbott Japan Co.,Ltd
INDUSTRY
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Yukihiro Kumamoto, MS
Role: STUDY_DIRECTOR
AbbVie Japan Co., Ltd
Related Links
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Related Info
Other Identifiers
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M12-925
Identifier Type: -
Identifier Source: org_study_id
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