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Trial record 3 of 18 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)

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ClinicalTrials.gov Identifier: NCT02549092
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : October 13, 2017
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Study Start Date : September 9, 2015
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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 :
  1. 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

  2. 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

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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  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 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.

  12. 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.

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

  14. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 99 Years   (Adult, Senior)
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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02549092

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

Royal Adelaide Hospital /ID# 136577 Recruiting
Adelaide, Australia, 5000
The Alfred Hospital /ID# 135962 Withdrawn
Melbourne, Australia, 3004
Royal Melbourne Hospital /ID# 136780 Recruiting
Parkville, Australia, 3050
Westmead Hospital /ID# 136575 Recruiting
Westmead, Australia, 2145
Cross Cancer Institute, University of Alberta /ID# 136586 Recruiting
Edmonton, Canada, T6G 2G3
The Ottawa Hospital Cancer Centre /ID# 139341 Recruiting
Ottawa, Canada, K1Y 4E9
Toronto Western Hospital /ID# 136585 Recruiting
Toronto, Canada, M5T 2S8
Charite Campus Benjamin Franklin /ID# 135958 Withdrawn
Berlin, Germany, 12203
St. Joseph-Krankenhaus Berlin-Weissensee /ID# 136758 Withdrawn
Berlin, Germany, 13088
Central Hospital Bremerhaven /ID# 136573 Recruiting
Bremerhaven, Germany, 27474
Uniklinik Koln /ID# 136839 Withdrawn
Cologne, Germany, 50937
Universitaetklinikum Dresden /ID# 136574 Withdrawn
Dresden, Germany, 01374
Universitaetsklinikum Duesseldorf /ID# 136777 Withdrawn
Duesseldorf, Germany, 40225
Universitaetsklinikum Ulm /ID# 136571 Withdrawn
Ulm, Germany, 89081
Azienda Ospedaliero Universitaria Ospedali Riuniti /ID# 135964 Recruiting
Ancona, Italy, 60020
DIBINEM - Universita di Bologna; IRCCS- ISNB /ID# 136789 Withdrawn
Bologna, Italy, 40139
A.O.U. Ospedali Riuniti di Foggia /ID# 136792 Recruiting
Foggia, Italy, 71121
UOSD Neurofisiopatologia e Disordini del Movimento /ID# 136790 Recruiting
Messina, Italy, 98125
Ospedale S.Maria della Misericordia- AO di Perugia /ID# 160609 Recruiting
Perugia, Italy, 06132
Azienda Sanitaria Locale Biella Nuovo Ospedale degli Infermi /ID# 160608 Recruiting
Ponderano (BI), Italy, 13875
Korea, Republic of
Severance Hospital /ID# 163019 Not yet recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center /ID# 163018 Not yet recruiting
Seoul, Korea, Republic of, 05505
Hospital de la Santa Creu i Sant Pau /ID# 136581 Recruiting
Barcelona, Spain, 08041
Ciutat Sanitaria I Universitaria de Belvitge /ID# 136579 Recruiting
Barcelona, Spain, 08907
Hospital Clinico y Provincial de Barcelona /ID# 137689 Recruiting
Barcelona, Spain, 8036
Hospital Puerta del Mar /ID# 157977 Recruiting
Cadiz, Spain, 11009
Hospital Campus de la Salud /ID# 136583 Recruiting
Granada- (Espana), Spain, 18016
Hospital Universitario Insular de Gran Canarias /ID# 136783 Recruiting
Las Palmas de Gran Canaria, Spain, 35016
Hospital Universitario Ramon y Cajal /ID# 136784 Recruiting
Madrid, Spain, 28034
Hospital Universitario Virgen del Rocio /ID# 145624 Recruiting
Seville, Spain, 41013
Hospital Universitario La Fe /ID# 136722 Recruiting
Valencia, Spain, 46026
Skanes Universitetssjukhus Lund /ID# 136587 Recruiting
Lund, Sweden, SE 221 85
Karolinska University Hospital - Huddinge /ID# 136588 Not yet recruiting
Stocholm, Sweden, 14186
Karolinska University Hospital /ID# 135961 Recruiting
Stockholm, Sweden, SE 171 76
Sponsors and Collaborators
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 )
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
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