Have you or your loved ones been diagnosed with advanced parkinson's disease?
You may be eligible to participate in a advanced parkinson's disease clinical trial.
Have you or your loved ones been diagnosed with advanced parkinson's disease? You may be eligible to participate in a advanced parkinson's disease clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Advanced Parkinson's Disease Clinical Trial in Foggia
Have you or your loved ones been diagnosed with advanced parkinson's disease?
You may be eligible to participate in a advanced parkinson's disease clinical trial.
Have you or your loved ones been diagnosed with advanced parkinson's disease? You may be eligible to participate in a advanced parkinson's disease clinical trial.
Active not recruiting
Male & Female
30 Years +
The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.
Details for the study
Brief Title
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)
Official Title
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
Brief Summary
The primary objective of this study is to examine the effect of LCIG relative to that of OMT <br /> on NMS associated with PD.
Detailed Description
The study will consist of 3 sequential parts:
Part 1: Screening period. The screening period will consist of 3 visits, Visit 1 (V1), Visit
2 ([V2] [optional]) and the Randomization Visit (V3) in which the participant will be
assessed to determine eligibility. The duration of the Screening Period can be between 30 to
67 days to accommodate the required procedures, training and collection of diaries, and to
allow for stabilization of anti-PD medications and medications to treat NMS. All anti-PD
medications and medications to treat NMS are required to be stable for a minimum of 30 days
prior to randomization.
Part 2: Treatment period. Those participants randomized to OMT at the end of V3 will remain
on their current optimized regimen. The day after randomization will be considered Day 1 of
their treatment period and participants will have study visits at the end of Weeks 2, 6, 12,
and 26. All participants randomized to the LCIG group should have all anti-PD medications,
with the exception of levodopa formulations, tapered off within 14 days after randomization.
Optional nasojujunal (NJ) and/or percutaneous endoscopic gastrostomy with a jejunal tube
(PEG-J) placement will then occur. After that, the participant may begin initiation and
titration of LCIG infusion to be adjusted to obtain the optimal clinical response. The day of
initial NJ or PEG-J placement will be considered Day 1 for participants in the LCIG group.
Study visits happen at the end of Weeks 2, 6, 12, and 26.
Part 3: Extension/Transition Period. Eligible participants who complete the 26 week study may
continue into the Extension Period of the study. Participants in the LCIG arm will have study
drug dispensation every 4 weeks and will have study visits every 6 months. Participants from
the OMT arm will undergo the NJ (optional) and PEG-J procedures, titration, plus have visits
at 2 weeks, 6 weeks, 3 months and 6 months post NJ or PEG-J. Participants will then continue
to receive study drug every 4 weeks and will have study visits every 6 months until Duodopa
is commercially available. Transition to a Post-Trial Access protocol will be possible if
Duodopa does not become commercially available in a location.
Treatments and/or Procedures
Nasojejunal NJ tube
optional prior to PEG-J placement
Optimized medical treatment
Oral, sublingual or transdermal anti-PD medications and medications to treat NMS per Investigator discretion and/or in accordance with approved product label of the prescribed medications.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Change From Baseline to Week 26 in the NMSS Total Score
The NMSS consists of 30 questions in 9 domains (cardiovascular/falls, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, GI tract, urinary, sexual function, miscellaneous). Score of each question is calculated by multiplying severity*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Total score is the sum of 9 domains, and ranges from 0 to 360, with a lower value indicating a more desirable outcome. Repeated-measure analysis.
Primary
Change From Baseline to Week 26 in the Modified PDSS-2 Total Score
The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Repeated measure analysis.
Secondary
Change From Baseline to Week 26 in Parkinson's Disease Questionnaire (PDQ-8) Summary Index Score
The PDQ-8 is a disease-specific instrument designed to measure aspects of health relevant to PD. Eight question including the mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort are assessed on a 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable). Summary index score is the sum of each question divided by 32 and multiplied by 100. Scores range from 0 to 100 with lower values desirable.
Secondary
Clinical Global Impression of Change (CGI-C) Final Score
CGI-C score is a clinician's impression of a subject's change in status on a 7-point scale (1 = very much improved, 2 = much improved, 3 = minimally Improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse). Scores range from 1 to 7, with lower score desirable.
Secondary
Change From Baseline at Week 26 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score
UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease of 42 total questions. Part I (Questions 1 - 4), Part II (Questions 5 - 17), Part III (Questions 18 - 31), and Part IV (Questions 32 - 42). Questions 35 - 38 and 40 - 42 are 2-point (0 and 1), all other questions are 5-point (0 - 4). Part II scores range from 0 to 52 with lower value desirable.
Secondary
Change From Baseline to Week 26 in the NMSS Domain Scores
The NMSS consists of 30 questions in 9 domains. Score of each question is calculated by multiplying severity*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Cardiovascular/falls scores range from 0 - 24 with lower value desirable. Sleep/fatigue scores range from 0 - 48 with lower value desirable. Mood/cognition scores range from 0 - 72 with lower value desirable. Perceptual problems/hallucinations scores range from 0 - 36 with lower value desirable. Attention/memory scores range from 0 - 36 with lower value desirable. Gastrointestinal tract scores range from 0 - 36 with lower value desirable. Urinary scores range from 0 - 36 with lower value desirable. Sexual function scores range from 0 - 24 with lower value desirable. Miscellaneous scores range from 0 - 48 with lower value desirable. Repeated-measure analysis.
Secondary
Change From Baseline at Week 26 in UPDRS Parts I, III, and IV Score
UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease of 42 total questions. Part I (Questions 1 - 4), Part II (Questions 5 - 17), Part III (Questions 18 - 31), and Part IV (Questions 32 - 42). Questions 35 - 38 and 40 - 42 are 2-point (0 and 1), all other questions are 5-point (0 - 4). Part I is the sum of Questions 1 - 4; scores range from 0 to 16 with lower value desirable. Part III is the sum of Questions 18 - 31 (Questions 20 - 26 apply to multiple body parts, resulting in 27 answers total); scores range from 0 to 108 with lower value desirable. Part IV is the sum of Questions 32 - 42; scores range from 0 to 23 with lower value desirable.
Secondary
Change From Baseline at Week 26 in Parkinson's Anxiety Scale (PAS) Total Score
PAS is a 12-item scale developed specifically to measure severity in anxiety in Parkinson's disease for the following items: Feeling anxious or nervous; Feeling tense or stressed; Being unable to relax; Excessive worrying about everyday matters; Fear of something bad, or even the worst, happening; Panic or intense fear; Shortness of breath; Heart palpitations or heart beating fast; Fear of losing control; Social situations; Public settings; Specific objects or situations. Severity for each item is rated as: 0, Never; 1 Rarely; 2, Sometimes; 3, Often; 4, Nearly always. Total score is the sum of the12 item scores, with a range of 0 to 48; a lower value is desirable.
Secondary
Change From Baseline at Week 26 in Geriatric Depression Scale (GDS-15) Score
The GDS-15 is a short, self-report reliable and valid screening instrument for depression in the elderly of 15 yes/no questions: 1) Satisfied with life 2) Dropped many activities and interests 3) Life is empty 4) Often get bored 5) In good spirits most of the time 6) Afraid that something bad is going to happen 7) Feel happy most of the time 8) Often feel helpless 9) Prefer to stay at home, rather than going out and doing things 10) Feel that have more problems with memory than most 11) Think it is wonderful to be alive now 12) Feel worthless 13) Feel full of energy 14) Situation is hopeless 15) Most subjects are better off. Answers of 'yes' to questions 2, 3, 4, 6, 8, 9, 10, 12, 14, 15 are scored 1 point. Answers of 'no' to questions 1, 5, 7, 11, 13 are scored 1 point. The 15 items are summed and scores range from 0 - 15 with lower value desirable.
Secondary
Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score
The KPPS score is a clinical PD-specific pain scale of 14 items addressing the following 7 domains: musculoskeletal pain, chronic pain, fluctuation-related pain, nocturnal pain, orofacial pain, neuropathic pain, radicular pain. Each domain item is scored by severity (0, none to 3, very severe) multiplied by frequency (0, never to 4, all the time) resulting in a subscore of 0 - 12 (with lower value desirable), the sum of the 14 items gives the total score with a range from 0 to 168 with lower value desirable.
Secondary
Patient Global Impression of Change (PGIC) Final Score
The PGIC is a 7-point response scale. The participant was asked by the Investigator or qualified designee to rate their change in status using the following 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. PGIC score ranges from 1 to 7 with lower score desirable.
Secondary
Change From Baseline to Week 26 in the Modified PDSS-2 Domain Scores
The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Repeated measure analysis.
Study Criteria
Inclusion Criteria: 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 optimized treatment. 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. 6. Minimum Parkinson's Disease Sleep Scale 2 (PDSS-2) total score of 18 at Baseline assessment. Exclusion Criteria: 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, malignant melanoma). 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 Principal Investigator.