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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02549092




Registration number
NCT02549092
Ethics application status
Date submitted
11/09/2015
Date registered
15/09/2015
Date last updated
13/05/2019

Titles & IDs
Public title
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)
Scientific 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
Secondary ID [1] 0 0
2014-004865-26
Secondary ID [2] 0 0
M12-927
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-SLV187

Active Comparator: Optimized Medical Treatment - 26 Week Period

Experimental: ABT-SLV187 - 26 Week Period


Treatment: Drugs: ABT-SLV187
Dose levels will be individually optimized.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in the Modified Parkinson's Disease Sleep Scale (PDSS-2) Total Score - 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
Timepoint [1] 0 0
Week 0-26
Primary outcome [2] 0 0
Change in the Non-Motor Symptoms Scale (NMSS) Total Score - 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
Timepoint [2] 0 0
Week 0-26
Secondary outcome [1] 0 0
Columbia-Suicide Severity Rating Scale (C-SSRS) - The C-SSRS is a systematically administered instrument designed to assess suicidal behavior and ideation.
Timepoint [1] 0 0
Week 0-26
Secondary outcome [2] 0 0
Change in 12-lead electrocardiogram (ECG) - 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.
Timepoint [2] 0 0
Week 0-26
Secondary outcome [3] 0 0
Change in Patient Global Impression of Change (PGIC) Score - 7-point response scale
Timepoint [3] 0 0
Week 0-26
Secondary outcome [4] 0 0
Minnesota Impulsive Disorders Interview (MIDI) - The MIDI is used to monitor for development of intense impulsive behavior.
Timepoint [4] 0 0
Week 0-26
Secondary outcome [5] 0 0
Number of Participants with Adverse Events - All negative changes in health during the study will be treated and recorded during the study.
Timepoint [5] 0 0
Week 0-26
Secondary outcome [6] 0 0
Change in King's PD Pain Scale Score - Clinical PD specific pain scale developed with a focus on sub classification of nociceptive pain and neuropathic pain
Timepoint [6] 0 0
Week 0-26
Secondary outcome [7] 0 0
Change in Geriatric Depression Scale (GDS-15) Score - A short, self-report reliable and valid screening instrument for depression in the elderly
Timepoint [7] 0 0
Week 0-26
Secondary outcome [8] 0 0
Change in Clinical Global Impression of Change (CGI-C) Score - Clinician's rating scale for assessing Global Improvement or Change
Timepoint [8] 0 0
Week 0-26
Secondary outcome [9] 0 0
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score - An investigator-used rating tool to follow the longitudinal course of Parkinson's disease
Timepoint [9] 0 0
Week 0-26
Secondary outcome [10] 0 0
Change in Sleep Attack Questionnaire (SAQ) Score - Assessment used to monitor for possible development of sleep attacks
Timepoint [10] 0 0
Week 0-26
Secondary outcome [11] 0 0
Change in Mini-Mental State Examination (MMSE) Score - 30 point questionnaire that provides a quantitative measure of cognitive mental status in adults
Timepoint [11] 0 0
Week 0-26
Secondary outcome [12] 0 0
Change in Montreal Cognitive Assessment (MoCA) Score - Screening tool to assess mild cognitive impairment in the general population, often used in clinical settings to study cognition in PD
Timepoint [12] 0 0
Week 0-26
Secondary outcome [13] 0 0
Change in Parkinson's Anxiety Scale (PAS) Score - Scale developed specifically to measure severity in anxiety in Parkinson's Disease
Timepoint [13] 0 0
Week 0-26
Secondary outcome [14] 0 0
Change in Parkinson's Disease Questionnaire (PDQ-8) Score - 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.
Timepoint [14] 0 0
Week 0-26

Eligibility
Key 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.
Minimum age
30 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital /ID# 136575 - Westmead
Recruitment hospital [2] 0 0
Royal Adelaide Hospital /ID# 136577 - Adelaide
Recruitment hospital [3] 0 0
Royal Melbourne Hospital /ID# 136780 - Parkville
Recruitment hospital [4] 0 0
Goulburn Valley Hospital /ID# 164202 - Shepparton
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
3630 - Shepparton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Germany
State/province [9] 0 0
Bremerhaven
Country [10] 0 0
Greece
State/province [10] 0 0
Athens
Country [11] 0 0
Greece
State/province [11] 0 0
Glyfada
Country [12] 0 0
Italy
State/province [12] 0 0
Marche
Country [13] 0 0
Italy
State/province [13] 0 0
Bologna
Country [14] 0 0
Italy
State/province [14] 0 0
Foggia
Country [15] 0 0
Italy
State/province [15] 0 0
Messina
Country [16] 0 0
Italy
State/province [16] 0 0
Perugia
Country [17] 0 0
Italy
State/province [17] 0 0
Ponderano,biella
Country [18] 0 0
Italy
State/province [18] 0 0
Roma
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul Teugbyeolsi
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Cadiz
Country [23] 0 0
Spain
State/province [23] 0 0
Granada
Country [24] 0 0
Spain
State/province [24] 0 0
Las Palmas
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Spain
State/province [26] 0 0
Sevilla
Country [27] 0 0
Spain
State/province [27] 0 0
Valencia
Country [28] 0 0
Sweden
State/province [28] 0 0
Solna

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT02549092
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02549092