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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02799381
Other study ID # M15-535
Secondary ID 2016-001403-23
Status Completed
Phase Phase 3
First received
Last updated
Start date February 9, 2017
Est. completion date September 19, 2019

Study information

Verified date August 2020
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study was to examine the effect of levodopa-carbidopa intestinal gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with advanced Parkinson's disease (PD).


Description:

This was a Phase 3b, open-label, randomized, multicenter, 12-week study. The study consisted of 3 sequential periods: Screening, Treatment, and Follow-Up. The OMT group had the same schedule of visits/procedures throughout the study as the LCIG treatment group, except for visits related to nasojejunal (NJ)/percutaneous endoscopic gastrostomy (PEG) procedures, titration of LCIG, and follow-up period.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date September 19, 2019
Est. primary completion date September 19, 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria:

- Participants must have a diagnosis of idiopathic Parkinson's disease (PD) according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria

- Participants with advanced levodopa-responsive PD and persistent motor fluctuations who have not been controlled with optimized medical treatment (OMT: the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected with regard to any additional manipulations of levodopa and/or other antiparkinsonian medication based on the Investigator's clinical judgment)

- Unified Dyskinesia Rating Scale (UDysRs) Total score = 30 at Visit 3

Exclusion Criteria:

- Participant(s) treated with levodopa-carbidopa intestinal gel (LCIG) previously

- 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

- Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.

- Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma)

- 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


Related Conditions & MeSH terms


Intervention

Drug:
Optimized antiparkinsonian treatment
Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect.
Levodopa-Carbidopa Intestinal Gel (LCIG)
Dose levels were individually optimized.
Device:
CADD-Legacy ambulatory infusion pump
(manufactured by Smiths Medical)
Percutaneous endoscopic gastrostomy tube
(PEG tube)
Jejunal extension tube
(J-tube)

Locations

Country Name City State
Finland Helsinki Univ Central Hospital /ID# 151214 Helsinki
Finland Oulun yliopistollinen sairaala /ID# 150947 Oulu
Greece Mediterraneo Hospital /ID# 150955 Glyfada
Greece University General Hospital of Heraklion "PA.G.N.I" /ID# 150956 Heraklion
Greece University Hospital of Ioannin /ID# 150954 Ioannina
Hungary Semmelweis Egyetem /ID# 170117 Budapest
Hungary Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 170116 Pécs Pecs
Hungary Szegedi Tudomanyegyetem /ID# 170115 Szeged
Italy A.O. Univ. Ospedali Riuniti /ID# 150853 Ancona Marche
Italy Azienda USL Toscana Centro /ID# 150770 Florence
Italy Seconda Universita' di Napoli /ID# 150851 Naples
Italy Policlinico Tor Vergata /ID# 151167 Rome
Italy Policlinico Universitario Campus Bio-Medico /ID# 150846 Rome Lazio
Slovakia Univerzitna Nemocnica Bratislava /ID# 150144 Bratislava
Slovakia Univerzitna Nemocnica Bratislava /ID# 150171 Bratislava
Slovakia Univerzitna nemocnica L. Pasteura /ID# 150146 Košice - Západ Kosicky Kraj
Slovakia Univerzitna nemocnica Martin /ID# 150145 Martin Zilinsky Kraj
Spain Hospital Universitario Cruces /ID# 203807 Barakaldo
Spain Hospital General Univ de Elche /ID# 150154 Elche
Spain Hospital General Universitario Gregorio Maranon /ID# 150155 Madrid
Spain Hospital Univ de la Princesa /ID# 150157 Madrid
Spain Hospital Univ Ramon y Cajal /ID# 150152 Madrid
Spain Hospital Universitario Infanta /ID# 159696 Madrid
Spain Hospital Regional Universitari /ID# 171485 Málaga Malaga
Spain Hospital Universitario Virgen Macarena /ID# 158861 Sevilla
Spain Hospital Virgen de la Salud /ID# 166297 Toledo
United States Parkinson's Disease Treatment Center of Southwest Florida /ID# 150095 Port Charlotte Florida
United States Central Texas Neurology Consul /ID# 150088 Round Rock Texas

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Finland,  Greece,  Hungary,  Italy,  Slovakia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score The Unified Dyskinesia Rating Scale (UDysRS) is a tool used to assess dyskinesia in Parkinson's disease (PD) and contains both self-evaluation questions and items that are assessed directly by the physician to objectively rate the abnormal movements associated with PD. Part 1 contains 11 questions about the ON time dyskinesia and the impact of ON-dyskinesia on experiences of daily living. Part 2 contains 4 questions about OFF-dystonia rating. Part 3 contains 7 questions about objective evaluation of dyskinesia impairment and Part 4 contains 4 questions regarding dyskinesia disability. Each question is scored with respect to severity, which is rated on a scale where 0 = normal, 1 = slight, 2 = mild, 3= moderate and 4 = severe. The UDysRS total score is obtained by summing the item scores, ranging from 0 to 104. Higher scores are associated with more disability. Negative changes from baseline indicate improvement. Baseline, Week 12
Secondary Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia The Parkinson's Disease (PD) Symptom Diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected study visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e., 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. ON time is when PD symptoms are well controlled by the drug, and OFF time is when PD symptoms are not adequately controlled by the drug. Positive change from baseline for ON time without troublesome dyskinesia indicates improvement. Baseline, Week 12
Secondary Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index The Parkinson's Disease Questionnaire-8 (PDQ-8) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. The PDQ-8 is a self-administered questionnaire. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable). Higher scores are consistently associated with the more severe symptoms of the disease such as tremors and stiffness. The results are presented as a summary index. The PDQ-8 summary index ranges from 0 to 100, where lower scores indicate a better perceived health status. Negative changes from baseline indicate improvement. Baseline, Week 12
Secondary Mean Clinical Global Impression of Change (CGI-C) Score at Week 12 The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement. Baseline, Week 12
Secondary Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living) The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Negative values indicate improvement from baseline. Baseline, Week 12
Secondary Mean Change From Baseline to Week 12 in OFF Time The Parkinson's Disease (PD) Symptom Diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected study visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e., 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. ON time is when PD symptoms are well controlled by the drug, and OFF time is when PD symptoms are not adequately controlled by the drug. Negative change from baseline for OFF time indicates improvement. Baseline, Week 12
Secondary Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score (Motor Examination) The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. Higher scores are associated with more disability. Negative values indicate improvement from baseline. Baseline, Week 12
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