Clinical Trial: 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)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Subj

Brief Summary: The primary objective of this study is to examine the effect of Levodopa-Carbidopa Intestinal Gel (LCIG) relative to that of OMT on non-motor symptoms associated with Parkinson's disease (PD).

Detailed Summary:
Sponsor: AbbVie

Current Primary Outcome:

• Change in the Non-Motor Symptoms Scale (NMSS) Total Score [ Time Frame: Week 0-26 ]
  Examine the effect of Levodopa-Carbidopa Intestinal Gel (LCIG) relative to that of Optimized Medical Treatment (OMT) on non-motor symptoms associated with advanced Parkinson's Disease (PD) as assessed by the Non-Motor Symptoms Scale (NMSS) Total Score
• Change in the Modified Parkinson's Disease Sleep Scale (PDSS-2) Total Score [ Time Frame: Week 0-26 ]
  Examine the effect of Levodopa-Carbidopa Intestinal Gel (LCIG) relative to that of Optimized Medical Treatment (OMT) on non-motor symptoms associated with advanced Parkinson's Disease (PD) as assessed by the Modified Parkinson's Disease Sleep Scale (PDSS-2) Total Score

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score [ Time Frame: Week 0-26 ]
  An investigator-used rating tool to follow the longitudinal course of Parkinson's disease
• Change in Clinical Global Impression of Change (CGI-C) Score [ Time Frame: Week 0-26 ]
  Clinician's rating scale for assessing Global Improvement or Change
• Change in Patient Global Impression of Change (PGIC) Score [ Time Frame: Week 0-26 ]
  7-point response scale
• Change in Parkinson's Disease Questionnaire (PDQ-8) Score [ Time Frame: Week 0-26 ]
  Disease-specific instrument designed to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.
• Change in Parkinson's Anxiety Scale (PAS) Score [ Time Frame: Week 0-26 ]
  Scale developed specifically to measure severity in anxiety in Parkinson's Disease
• Change in Geriatric Depression Scale (GDS-15) Score [ Time Frame: Week 0-26 ]
  A short, self-report reliable and valid screening instrument for depression in the elderly
• Change in King's PD Pain Scale Score [ Time Frame: Week 0-26 ]
  Clinical PD specific pain scale developed with a focus on sub classification of nociceptive pain and neuropathic pain
• Change in Montreal Cognitive Assessment (MoCA) Score [ Time Frame: Week 0-26 ]
  Screening tool to assess mild cognitive impairment in the general population, often used in clinical settings to study cognition in PD
• Change in Mini-Mental State Examination (MMSE) Score [ Time Frame: Week 0-26 ]
  30 point questionnaire that provides a quantitative measure of cognitive mental status in adults
• Change in Sleep Attack Questionnaire (SAQ) Score [ Time Frame: Week 0-26 ]
  Assessment used to monitor for possible development of sleep attacks
• Change in 12-lead electrocardiogram (ECG) [ Time Frame: Week 0-26 ]
  ECGs will be recorded after laying down for at least 5 minutes and will be recorded while completely stationary, without talking, laughing, deep breathing or swallowing during the time of recording.
• Number of Participants with Adverse Events [ Time Frame: Week 0-26 ]
  All negative changes in health during the study will be treated and recorded during the study.
• Minnesota Impulsive Disorders Interview (MIDI) [ Time Frame: Week 0-26 ]
  The MIDI is used to monitor for development of intense impulsive behavior.
• Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Week 0-26 ]
  The C-SSRS is a systematically administered instrument designed to assess suicidal behavior and ideation.

Original Secondary Outcome:

• Change in Neurological Exam [ Time Frame: Week 0-26 ]
  A Neurological Examination including light touch and pinprick sensation, vibratory sensation, deep tendon reflexes, and strength assessments will be performed
• Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score [ Time Frame: Week 0-26 ]
  An investigator-used rating tool to follow the longitudinal course of Parkinson's disease
• Change in Clinical Global Impression of Change (CGI-C) Score [ Time Frame: Week 0-26 ]
  Clinician's rating scale for assessing Global Improvement or Change
• Change in Patient Global Impression of Change (PGIC) Score [ Time Frame: Week 0-26 ]
  7-point response scale
• Change in Parkinson's Disease Questionnaire (PDQ-8) Score [ Time Frame: Week 0-26 ]
  Disease-specific instrument designed to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.
• Change in Parkinson's Anxiety Scale (PAS) Score [ Time Frame: Week 0-26 ]
  Scale developed specifically to measure severity in anxiety in Parkinson's Disease
• Change in Geriatric Depression Scale (GDS-15) Score [ Time Frame: Week 0-26 ]
  A short, self-report reliable and valid screening instrument for depression in the elderly
• Change in King's PD Pain Scale Score [ Time Frame: Week 0-26 ]
  Clinical PD specific pain scale developed with a focus on sub classification of nociceptive pain and neuropathic pain
• Change in Montreal Cognitive Assessment (MoCA) Score [ Time Frame: Week 0-26 ]
  Screening tool to assess mild cognitive impairment in the general population, often used in clinical settings to study cognition in PD
• Change in Mini-Mental State Examination (MMSE) Score [ Time Frame: Week 0-26 ]
  30 point questionnaire that provides a quantitative measure of cognitive mental status in adults
• Change in Sleep Attack Assessment Score [ Time Frame: Week 0-26 ]
  Assessment used to monitor for possible development of sleep attacks
• Change in 12-lead electrocardiogram (ECG) [ Time Frame: Week 0-26 ]
  ECGs will be recorded after laying down for at least 5 minutes and will be recorded while completely stationary, without talking, laughing, deep breathing or swallowing during the time of recording
• Number of Participants with Adverse Events [ Time Frame: Week 0-26 ]
  All negative changes in health during the study will be treated and recorded during the study.

Information By: AbbVie

Dates:
Date Received: September 11, 2015
Date Started: September 2015
Date Completion: November 2018
Last Updated: April 10, 2017
Last Verified: April 2017