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 enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02549092
First received: September 11, 2015
Last updated: April 1, 2016
Last verified: April 2016
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Neurological Exam [ Time Frame: Week 0-26 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Clinician's rating scale for assessing Global Improvement or Change

  • Change in Patient Global Impression of Change (PGIC) Score [ Time Frame: Week 0-26 ] [ Designated as safety issue: No ]
    7-point response scale

  • Change in Parkinson's Disease Questionnaire (PDQ-8) Score [ Time Frame: Week 0-26 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessment used to monitor for possible development of sleep attacks

  • Change in 12-lead electrocardiogram (ECG) [ Time Frame: Week 0-26 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    All negative changes in health during the study will be treated and recorded during the study.


Estimated Enrollment: 88
Study Start Date: September 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (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 and older   (Adult, Senior)
Genders Eligible for Study:   Both
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

Locations
Australia
Site Reference ID/Investigator# 136577
Adelaide, Australia, 5000
Site Reference ID/Investigator# 135962
Melbourne, Australia, 3004
Site Reference ID/Investigator# 136780
Parkville, Australia, 3050
Site Reference ID/Investigator# 136575
Westmead, Australia, 2145
Canada
Site Reference ID/Investigator# 136586
Edmonton, Canada, T6G 2G3
Site Reference ID/Investigator# 139341
Ottawa, Canada, K1Y 4E9
Site Reference ID/Investigator# 136585
Toronto, Canada, M5T 2S8
Germany
Site Reference ID/Investigator# 135958
Berlin, Germany, 12203
Site Reference ID/Investigator# 136758
Berlin, Germany, 13088
Site Reference ID/Investigator# 136573
Bremerhaven, Germany, 27474
Site Reference ID/Investigator# 136839
Cologne, Germany, 50937
Site Reference ID/Investigator# 136574
Dresden, Germany, 01374
Site Reference ID/Investigator# 136777
Duesseldorf, Germany, 40225
Site Reference ID/Investigator# 136571
Ulm, Germany, 89081
Italy
Site Reference ID/Investigator# 135964
Ancona, Italy, 60020
Site Reference ID/Investigator# 136789
Bologna, Italy, 40139
Site Reference ID/Investigator# 136792
Foggia, Italy, 71121
Site Reference ID/Investigator# 136790
Messina, Italy, 98125
Spain
Site Reference ID/Investigator# 136581
Barcelona, Spain, 08041
Site Reference ID/Investigator# 136579
Barcelona, Spain, 08907
Site Reference ID/Investigator# 136583
Granada, Spain, 18013
Site Reference ID/Investigator# 136783
Las Palmas de Gran Canaria, Spain, 35016
Site Reference ID/Investigator# 136784
Madrid, Spain, 28034
Site Reference ID/Investigator# 145624
Seville, Spain, 41013
Site Reference ID/Investigator# 136722
Valencia, Spain, 46026
Sweden
Site Reference ID/Investigator# 136587
Lund, Sweden, SE 221 85
Site Reference ID/Investigator# 136588
Stocholm, Sweden, 14186
Site Reference ID/Investigator# 135961
Stockholm, Sweden, SE 171 76
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 
Study First Received: September 11, 2015
Last Updated: April 1, 2016
Health Authority: Canada: Ethics Review Committee
Sweden: Institutional Review Board
Germany: Ethics Commission
Spain: Comité Ético de Investigación Clínica
Australia: National Health and Medical Research Council
Canada: Health Canada
Italy: Ethics Committee
Sweden: Medical Products Agency
Germany: Ministry of Health
United States: Food and Drug Administration
Australia: Human Research Ethics Committee
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios

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
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

ClinicalTrials.gov processed this record on July 26, 2016