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Trial record 3 of 17 for:    LCIG

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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02549092
First received: September 11, 2015
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Advanced Parkinson's Disease
Drug: ABT-SLV187
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 88
Study Start Date: September 2015
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-SLV187
26 Week Period
Drug: ABT-SLV187
Dose levels will be individually optimized.
Active Comparator: Optimized Medical Treatment
26 Week Period
Drug: ABT-SLV187
Dose levels will be individually optimized.

  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02549092

Contacts
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

Locations
Australia
Site Reference ID/Investigator# 136577 Recruiting
Adelaide, Australia, 5000
Principal Investigator: Site Reference ID/Investigator# 136577, MD         
Site Reference ID/Investigator# 135962 Withdrawn
Melbourne, Australia, 3004
Site Reference ID/Investigator# 136780 Recruiting
Parkville, Australia, 3050
Principal Investigator: Site Reference ID/Investigator# 136780, MD         
Site Reference ID/Investigator# 136575 Recruiting
Westmead, Australia, 2145
Principal Investigator: Site Reference ID/Investigator# 136575, MD         
Canada
Site Reference ID/Investigator# 136586 Recruiting
Edmonton, Canada, T6G 2G3
Principal Investigator: Site Reference ID/Investigator# 136586, MD         
Site Reference ID/Investigator# 139341 Recruiting
Ottawa, Canada, K1Y 4E9
Principal Investigator: Site Reference ID/Investigator# 139341, MD         
Site Reference ID/Investigator# 136585 Recruiting
Toronto, Canada, M5T 2S8
Principal Investigator: Site Reference ID/Investigator# 136585, MD         
Germany
Site Reference ID/Investigator# 135958 Recruiting
Berlin, Germany, 12203
Principal Investigator: Site Reference ID/Investigator# 135958, MD         
Site Reference ID/Investigator# 136758 Recruiting
Berlin, Germany, 13088
Principal Investigator: Site Reference ID/Investigator# 136758, MD         
Site Reference ID/Investigator# 136573 Recruiting
Bremerhaven, Germany, 27474
Principal Investigator: Site Reference ID/Investigator# 136573, MD/PhD         
Site Reference ID/Investigator# 136839 Withdrawn
Cologne, Germany, 50937
Site Reference ID/Investigator# 136574 Recruiting
Dresden, Germany, 01374
Principal Investigator: Site Reference ID/Investigator# 136574, MD         
Site Reference ID/Investigator# 136777 Recruiting
Duesseldorf, Germany, 40225
Principal Investigator: Site Reference ID/Investigator# 136777, MD         
Site Reference ID/Investigator# 136571 Recruiting
Ulm, Germany, 89081
Principal Investigator: Site Reference ID/Investigator# 136571, MD         
Italy
Site Reference ID/Investigator# 135964 Recruiting
Ancona, Italy, 60020
Principal Investigator: Site Reference ID/Investigator# 135964, MD         
Site Reference ID/Investigator# 136789 Withdrawn
Bologna, Italy, 40139
Site Reference ID/Investigator# 136792 Recruiting
Foggia, Italy, 71121
Principal Investigator: Site Reference ID/Investigator# 136792, MD         
Site Reference ID/Investigator# 136790 Recruiting
Messina, Italy, 98125
Principal Investigator: Site Reference ID/Investigator# 136790, MD         
Spain
Site Reference ID/Investigator# 136581 Recruiting
Barcelona, Spain, 08041
Principal Investigator: Site Reference ID/Investigator# 136581, MD/PhD         
Site Reference ID/Investigator# 136579 Recruiting
Barcelona, Spain, 08907
Principal Investigator: Site Reference ID/Investigator# 136579, MD         
Site Reference ID/Investigator# 137689 Recruiting
Barcelona, Spain, 8036
Principal Investigator: Site Reference ID/Investigator# 137689, MD         
Site Reference ID/Investigator# 136583 Recruiting
Granada- (Espana), Spain, 18016
Principal Investigator: Site Reference ID/Investigator# 136583, MD         
Site Reference ID/Investigator# 136783 Recruiting
Las Palmas de Gran Canaria, Spain, 35016
Principal Investigator: Site Reference ID/Investigator# 136783, MD         
Site Reference ID/Investigator# 136784 Recruiting
Madrid, Spain, 28034
Principal Investigator: Site Reference ID/Investigator# 136784, MD/PhD         
Site Reference ID/Investigator# 145624 Recruiting
Seville, Spain, 41013
Principal Investigator: Site Reference ID/Investigator# 145624, MD         
Site Reference ID/Investigator# 136722 Recruiting
Valencia, Spain, 46026
Principal Investigator: Site Reference ID/Investigator# 136722, MD         
Sweden
Site Reference ID/Investigator# 136587 Recruiting
Lund, Sweden, SE 221 85
Principal Investigator: Site Reference ID/Investigator# 136587, MD         
Site Reference ID/Investigator# 136588 Not yet recruiting
Stocholm, Sweden, 14186
Principal Investigator: Site Reference ID/Investigator# 136588, MD         
Site Reference ID/Investigator# 135961 Recruiting
Stockholm, Sweden, SE 171 76
Principal Investigator: Site Reference ID/Investigator# 135961, MD         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Janet Benesh, BS AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02549092     History of Changes
Other Study ID Numbers: M12-927
2014-004865-26 ( EudraCT Number )
Study First Received: September 11, 2015
Last Updated: February 23, 2017

Keywords provided by AbbVie:
carbidopa
efficacy
Advanced Parkinson's Disease
Parkinson's Disease Sleep Scale PDSS-2
levodopa-carbidopa intestinal gel
Non-Motor Symptom Scale NMSS
levodopa

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa, levodopa drug combination
Carbidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on March 24, 2017