Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

AbbVie

Status and phase: Completed; Phase 3

Conditions: Advanced Parkinson's Disease

Treatments: Device: J-tube; Device: CADD-Legacy® 1400 ambulatory infusion pump; Drug: Levodopa-carbidopa intestinal gel; Device: PEG tube

Study type: Interventional

Funder types: Industry

Identifiers

NCT00335153

2006-005186-18 (EudraCT Number)

S187.3.004

Details and patient eligibility

About

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.

Full description

The study was composed of a screening period followed by 3 sequential on-treatment periods, as follows:

• Screening Period (up to 28 days): determination of eligibility and discontinuation of antiparkinsonian disease medications other than levodopa-carbidopa immediate release (LC-oral) prior to nasojejunal (NJ) tube placement.
• NJ Test Period (2 to 14 days): first hospitalization period, Baseline assessments, placement of NJ tube, and optimization of levodopa-carbidopa intestinal gel (LCIG) treatment via NJ tube and infusion pump (participant was hospitalized for NJ tube placement but hospitalization was not required for entire duration of LCIG treatment optimization).
• PEG-J Period (2 to 14 days): second hospitalization period; placement of PEG-J tube; further optimization of LCIG treatment.
• Post PEG-J Long-Term Treatment Period (Day 28 to Day 378): LCIG administration via a permanent PEG-J tube and infusion pump, with dosage adjusted according to clinical condition.

Enrollment: 354 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
• Levodopa-responsive with severe motor fluctuations
• Recognizable off and on state (motor fluctuations) confirmed by diary

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 (such as narrow angle glaucoma)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

354 participants in 1 patient group

Levodopa-Carbidopa Intestinal Gel (LCIG)

Experimental group

Description:

All participants were to receive LCIG, via the NJ tube during the nasojejunal (NJ) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Treatment:

Device: J-tube

Device: CADD-Legacy® 1400 ambulatory infusion pump

Device: PEG tube

Drug: Levodopa-carbidopa intestinal gel