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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02549092
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : May 13, 2019
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Advanced Parkinson's Disease Drug: ABT-SLV187 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 9, 2015
Estimated Primary Completion Date : January 2, 2020
Estimated Study Completion Date : January 2, 2020

Arm Intervention/treatment
Active Comparator: Optimized Medical Treatment
26 Week Period
Drug: ABT-SLV187
Dose levels will be individually optimized.

Experimental: ABT-SLV187
26 Week Period
Drug: ABT-SLV187
Dose levels will be individually optimized.

Primary Outcome Measures :
  1. 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

  2. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in Patient Global Impression of Change (PGIC) Score [ Time Frame: Week 0-26 ]
    7-point response scale

  4. Minnesota Impulsive Disorders Interview (MIDI) [ Time Frame: Week 0-26 ]
    The MIDI is used to monitor for development of intense impulsive behavior.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. Change in Sleep Attack Questionnaire (SAQ) Score [ Time Frame: Week 0-26 ]
    Assessment used to monitor for possible development of sleep attacks

  11. 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

  12. 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

  13. 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

  14. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02549092

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Contact: ABBVIE CALL CENTER 847.283.8955

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Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie Identifier: NCT02549092     History of Changes
Other Study ID Numbers: M12-927
2014-004865-26 ( EudraCT Number )
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
levodopa-carbidopa intestinal gel
Advanced Parkinson's Disease
Non-Motor Symptom Scale NMSS
Parkinson's Disease Sleep Scale PDSS-2
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists