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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Advanced Parkinson's Disease

Treatments: Device: NJ-Tube: Silicon ED Tube; Drug: Oral Levodopa/Carbidopa; Device: Adaptor: Hakko Adaptor; Drug: ABT-SLV187; Device: Infusion Pump: CADD-Legacy® 1400 Pump

Study type: Interventional

Funder types: Industry

Identifiers

NCT01479127

M12-925

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 30 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Levodopa-carbidopa intestinal gel

Experimental group

Description:

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.

Treatment:

Drug: Oral Levodopa/Carbidopa

Device: Infusion Pump: CADD-Legacy® 1400 Pump

Drug: ABT-SLV187

Device: NJ-Tube: Silicon ED Tube

Device: Adaptor: Hakko Adaptor