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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02549092
Ethics application status
Date submitted
11/09/2015
Date registered
15/09/2015

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 - Optimized Medical Treatment
Treatment: Devices - Nasojejunal (NJ) tube

Active comparator: Optimized Medical Treatment (OMT) - Participants randomized to continue OMT remain on their current optimized regimen. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.

Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG.

Experimental: Levodopa-Carbidopa Intestinal Gel (LCIG) - Participants randomized to LCIG at an individually optimized dose (after NJ and/or PEG-J placement), in accordance with the LCIG approved product label for countries participating in the study. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.

The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion is expected to run over a period of 16 consecutive hours each day.

Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG.


Treatment: Drugs: Optimized Medical Treatment
Oral, sublingual or transdermal anti-PD medications and medications to treat NMS per Investigator discretion and/or in accordance with approved product label of the prescribed medications.

Treatment: Devices: Nasojejunal (NJ) tube
optional prior to PEG-J placement
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 26 in the NMSS Total Score
Timepoint [1] 0 0
Baseline, Week 26
Primary outcome [2] 0 0
Change From Baseline to Week 26 in the Modified PDSS-2 Total Score
Timepoint [2] 0 0
Baseline, Week 26
Secondary outcome [1] 0 0
Change From Baseline to Week 26 in Parkinson's Disease Questionnaire (PDQ-8) Summary Index Score
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [2] 0 0
Clinical Global Impression of Change (CGI-C) Final Score
Timepoint [2] 0 0
End of Treatment Period (up to Week 26)
Secondary outcome [3] 0 0
Change From Baseline at Week 26 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score
Timepoint [3] 0 0
Baseline, Week 26
Secondary outcome [4] 0 0
Change From Baseline to Week 26 in the NMSS Domain Scores
Timepoint [4] 0 0
Baseline, Week 26
Secondary outcome [5] 0 0
Change From Baseline to Week 26 in the Modified PDSS-2 Domain Scores
Timepoint [5] 0 0
Baseline, Week 26
Secondary outcome [6] 0 0
Change From Baseline at Week 26 in UPDRS Parts I, III, and IV Score
Timepoint [6] 0 0
Baseline, Week 26
Secondary outcome [7] 0 0
Change From Baseline at Week 26 in Parkinson's Anxiety Scale (PAS) Total Score
Timepoint [7] 0 0
Baseline, Week 26
Secondary outcome [8] 0 0
Change From Baseline at Week 26 in Geriatric Depression Scale (GDS-15) Score
Timepoint [8] 0 0
Baseline, Week 26
Secondary outcome [9] 0 0
Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score
Timepoint [9] 0 0
Baseline, Week 26
Secondary outcome [10] 0 0
Patient Global Impression of Change (PGIC) Final Score
Timepoint [10] 0 0
End of Treatment Period (up to Week 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.
6. Minimum Parkinson's Disease Sleep Scale 2 (PDSS-2) total score of 18 at Baseline assessment.
Minimum age
30 Years
Maximum age
No limit
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/11/2022
Sample size
Target
Accrual to date
Final
89
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
Attiki
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
Las Palmas
Country [23] 0 0
Spain
State/province [23] 0 0
Cadiz
Country [24] 0 0
Spain
State/province [24] 0 0
Granada
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02549092