A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)
Advanced Parkinson's Disease
About this trial
This is an interventional treatment trial for Advanced Parkinson's Disease focused on measuring levodopa-carbidopa intestinal gel, levodopa, carbidopa, Advanced Parkinson's Disease, Non-Motor Symptom Scale NMSS, Parkinson's Disease Sleep Scale PDSS-2, efficacy
Eligibility Criteria
Inclusion Criteria:
- Participant(s) must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria.
- Participant(s) demonstrates persistent motor fluctuations in spite of individually optimized treatment.
- The participant's Parkinson's disease is levodopa-responsive.
- Participant(s) has had optimized 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.
- Male or female participant(s) must be at least 30 years of age.
- Minimum Parkinson's Disease Sleep Scale 2 (PDSS-2) total score of 18 at Baseline assessment.
Exclusion Criteria:
- Participant'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.
- Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.
- Known hypersensitivity to levodopa, carbidopa or radiopaque material.
- Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma).
- Participant(s) 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 Principal Investigator.
Sites / Locations
- Parkinson's and Movement /ID# 161596
- Boca Raton Regional Hospital /ID# 200056
- University of Florida Neurolog /ID# 168699
- Parkinson's Disease Treatment Center of Southwest Florida /ID# 168085
- Rush University Medical Center /ID# 168088
- St. Luke's Health System /ID# 168706
- Central Texas Neurology Consul /ID# 168087
- Inland Northwest Research /ID# 200113
- Westmead Hospital /ID# 136575
- Royal Adelaide Hospital /ID# 136577
- Royal Melbourne Hospital /ID# 136780
- Goulburn Valley Hospital /ID# 164202
- University of Alberta /ID# 136586
- The Ottawa Hospital /ID# 139341
- Toronto Western Hospital /ID# 136585
- Central Hospital Bremerhaven /ID# 136573
- 251 Airforce General Hospital /ID# 160594
- Mediterraneo Hospital /ID# 208042
- A.O. Univ. Ospedali Riuniti /ID# 135964
- Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 136789
- A.O.U. Ospedali Riuniti di Fog /ID# 136792
- A.O.U. Policlinico G. Martino /ID# 136790
- Ospedale S.Maria della Miseri /ID# 160609
- Azienda Sanitaria Locale di /ID# 160608
- Azienda Policlinico Umberto I /ID# 201223
- Severance Hospital /ID# 163019
- Seoul National University Hospital /ID# 162990
- Asan Medical Center /ID# 163018
- Hospital Universitario de Bellvitge /ID# 136579
- CHU Insular-Materno Infantil /ID# 136783
- Hospital Clinic de Barcelona /ID# 137689
- Hospital Santa Creu i Sant Pau /ID# 136581
- Hospital Puerta del Mar /ID# 157977
- Hospital Universitario Virgen de las Nieves /ID# 136583
- Hospital Universitario Ramon y Cajal /ID# 136784
- Hospital Universitario Virgen del Rocio /ID# 145624
- Hospital Universitario y Politecnico La Fe /ID# 136722
- Karolinska Univ Sjukhuset /ID# 135961
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Optimized Medical Treatment (OMT)
Levodopa-Carbidopa Intestinal Gel (LCIG)
Participants randomized to continue OMT remain on their current optimized regimen. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG.
Participants randomized to LCIG at an individually optimized dose (after NJ and/or PEG-J placement), in accordance with the LCIG approved product label for countries participating in the study. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion is expected to run over a period of 16 consecutive hours each day. Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG.