26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease

Phase 1

• Conditions: on-motor symptoms in advanced Parkinson's disease; MedDRA version: 19.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-004865-26-SE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-25
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Subject must have a minimum PDSS-2 total score of 18 at Baseline assessment.
2. Subject must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria. See Appendix C for UKPDS.
3. Subject demonstrates persistent motor fluctuations in spite of individually optimized treatment.
4. The subject's Parkinson's disease is levodopa-responsive.
5. Subject has had optimal treatment with available anti-PD medication and their motor symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of levodopa and/or other antiparkinsonian medication. This will be based on the Investigator's clinical judgment.
6. Subject and/or if applicable, their care-partner must be able to complete the Subject Dosing Diary and must be able to demonstrate the ability to operate, manipulate and care for the infusion pump and tubing.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

1. Subject's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g., Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD.
2. Subject has undergone neurosurgery for the treatment of Parkinson's disease.
3. Subject has any neurological deficit that might interfere with the study assessments (e.g., hemiparesis).
4. Known hypersensitivity to levodopa, carbidopa or radiopaque material.
5. Subject has contraindications to levodopa, (e.g., narrow angle glaucoma, malignant melanoma).
6. Subject experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g., pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation) as judged by the Investigator.
7. Subject has discontinued apomorphine continuous infusion for the treatment of Parkinson's disease less than three months prior to screening visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to examine the effect of LCIG relative to that of OMT on non motor symptoms associated with advanced Parkinson's disease.;Secondary Objective: To assess the effect of LCIG relative to that of OMT on the motor symptoms/motor complications, safety, tolerability and health-related outcome measures.;Primary end point(s): Non-Motor Symptoms Scale (NMSS) Total Score and the Modified Parkinson's Disease Sleep Scale (PDSS-2) Total Score.;Timepoint(s) of evaluation of this end point: Baseline, Week 6, Week 12, Week 26