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A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER) (DYSCOVER)

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ClinicalTrials.gov Identifier: NCT02799381
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The primary objective of this study is 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).

Condition or disease Intervention/treatment Phase
Parkinson's Disease (PD) Drug: ABT-SLV187 Drug: optimized antiparkinsonian treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)
Actual Study Start Date : February 9, 2017
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Optimized Medical Treatment
12 Week Period
Drug: optimized antiparkinsonian treatment
Dose levels of prescribed antiparkinsonian medications will be individually optimized to their maximum therapeutic effect.

Experimental: ABT-SLV187
12 Week Period
Drug: ABT-SLV187
Dose levels will be individually optimized.
Other Name: Carbidopa-Levodopa Enteral Suspension LCIG




Primary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS) Total Score [ Time Frame: 12 weeks ]
    The UDysRS is used to evaluate on-dyskinesia in Parkinson's disease and the impact of on-dyskinesia on experiences of daily living.


Secondary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score (Motor Examination) [ Time Frame: 12 weeks ]
    The UPDRS is a rating tool to follow the longitudinal course of Parkinson's disease.

  2. OFF time [ Time Frame: 12 weeks ]
    OFF time as measured by Parkinson's disease Diary, which the subject and/or caregiver uses to record Parkinsonian symptoms.

  3. Clinical Global Impression of Change (CGI-C) Score [ Time Frame: 12 weeks ]
    The CGI-C is a rating scale for assessing Global Improvement or Change.

  4. ON time without troublesome dyskinesia [ Time Frame: 12 weeks ]
    "ON" time without troublesome dyskinesia as measured by the Parkinson's disease Diary, which the subject and/or caregiver uses to record Parkinsonian symptoms.

  5. Parkinson's Disease Questionaire-8 (PDQ-8) Summary Index [ Time Frame: 12 weeks ]
    The PDQ-8 is a self-administered questionnaire that measures aspects of health that are relevant to subjects with PD that may not be included in general health status questionnaires.

  6. Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living) [ Time Frame: 12 weeks ]
    The UPDRS is a rating tool to follow the longitudinal course of Parkinson's disease.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Patient(s) treated with LCIG previously
  • Patient'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
  • Patient(s) has undergone neurosurgery for the treatment of Parkinson's disease.
  • Patient(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma)
  • Patient(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

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): NCT02799381


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Florida
Parkinson's Disease Treatment Center of Southwest Florida /ID# 150095 Completed
Port Charlotte, Florida, United States, 33980
United States, Texas
Central Texas Neurology Consul /ID# 150088 Completed
Round Rock, Texas, United States, 78681
Finland
Helsinki Univ Central Hospital /ID# 151214 Recruiting
Helsinki, Finland, 00290
Oulun yliopistollinen sairaala /ID# 150947 Recruiting
Oulu, Finland, 90220
Greece
University General Hospital "Attikon" /ID# 200761 Not yet recruiting
Athens, Attiki, Greece, 12462
Mediterraneo Hospital /ID# 150955 Recruiting
Glyfada, Greece, 16675
University General Hospital of Heraklion "PA.G.N.I" /ID# 150956 Recruiting
Heraklion, Greece, 71110
University Hospital of Ioannin /ID# 150954 Recruiting
Ioannina, Greece, 45500
Hungary
Pecsi Tudomanyegyetem /ID# 170116 Recruiting
Pécs, Pecs, Hungary, 7624
Semmelweis Egyetem /ID# 170117 Recruiting
Budapest, Hungary, 1085
Szegedi Tudomanyegyetem /ID# 170115 Recruiting
Szeged, Hungary, 6720
Italy
Policlinico Universitario Campus Bio-Medico /ID# 150846 Recruiting
Rome, Lazio, Italy, 00128
A.O. Univ. Ospedali Riuniti /ID# 150853 Recruiting
Ancona, Marche, Italy, 60126
A.O.U Sant'Anna di Ferrara /ID# 202497 Not yet recruiting
Ferrara, Italy, 44124
Azienda USL Toscana Centro /ID# 150770 Recruiting
Florence, Italy, 50012
Seconda Universita' di Napoli /ID# 150851 Recruiting
Naples, Italy, 80138
Policlinico Tor Vergata /ID# 151167 Recruiting
Rome, Italy, 00133
Slovakia
Univerzitna nemocnica L. Pasteura /ID# 150146 Recruiting
Košice - Sever, Kosicky Kraj, Slovakia, 040 01
Univerzitna nemocnica Martin /ID# 150145 Recruiting
Martin, Zilinsky Kraj, Slovakia, 036 01
Univerzitna Nemocnica Bratislava /ID# 150144 Recruiting
Bratislava, Slovakia, 826 06
Univerzitna Nemocnica Bratislava /ID# 150171 Recruiting
Bratislava, Slovakia, 826 06
Spain
Hospital Regional Universitari /ID# 171485 Recruiting
Málaga, Malaga, Spain, 29010
Hospital Universitario Cruces /ID# 203807 Recruiting
Barakaldo, Spain, 48903
Hospital General Univ de Elche /ID# 150154 Recruiting
Elche, Spain, 03202
Hospital Univ de la Princesa /ID# 150157 Recruiting
Madrid, Spain, 28006
Hospital General Universitario Gregorio Maranon /ID# 150155 Recruiting
Madrid, Spain, 28007
Hospital Univ Ramon y Cajal /ID# 150152 Completed
Madrid, Spain, 28034
Hospital Universitario Infanta /ID# 159696 Recruiting
Madrid, Spain, 28702
Hospital Universitario Virgen Macarena /ID# 158861 Recruiting
Sevilla, Spain, 41009
Hospital Virgen de la Salud /ID# 166297 Recruiting
Toledo, Spain, 45005
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02799381     History of Changes
Other Study ID Numbers: M15-535
2016-001403-23 ( EudraCT Number )
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: 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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
carbidopa
levodopa
efficacy
levodopa-carbidopa intestinal gel
Advanced Parkinson's Disease

Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
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