An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson’s Disease – INSIGHTS Study
Gel (LCIG) relative to that of OMT on non-motor symptoms associated with Parkinson’s disease
1. Participant(s) must have a diagnosis of idiopathic Parkinson’s disease according to
the United Kingdom Parkinson’s Disease Society (UKPDS) Brain Bank Criteria.
2. Participant(s) demonstrates persistent motor fluctuations in spite of individually
3. The participant’s Parkinson’s disease is levodopa-responsive.
4. 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.
5. Male or female participant(s) must be at least 30 years of age.
1. 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.
2. Participant(s) has undergone neurosurgery for the treatment of Parkinson’s disease.
3. Known hypersensitivity to levodopa, carbidopa or radiopaque material.
4. Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma,
5. 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
- Parkinson’s and Movement /ID# 161596, Fountain Valley, California, United States, 92708