Conditions: Advanced Parkinson's Disease
Keywords: Levodopa-carbidopa intestinal gel Advanced Parkinson's disease Severe motor fluctuations Dyskinesia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: ABT-SLV187 intervention 2: Oral Levodopa/Carbidopa intervention 3: Infusion Pump: CADD-Legacy® 1400 Pump intervention 4: NJ-Tube: Silicon ED Tube intervention 5: Adaptor: Hakko Adaptor
Intervention descriptions: intervention 1: None intervention 2: Tablet; contains 100 mg levodopa and 10 mg carbidopa intervention 3: General infusion pump, manufactured by Smiths Medical (US) intervention 4: Device used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan) intervention 5: Accessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)

Protocol document: