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An 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)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02799381
First received: June 10, 2016
Last updated: June 28, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Advanced Parkinson's Disease Drug: ABT-SLV187 Drug: optimized antiparkinsonian treatment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 60
Actual Study Start Date: February 9, 2017
Estimated Study Completion Date: July 19, 2019
Estimated Primary Completion Date: May 4, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-SLV187
12 Week Period
Drug: ABT-SLV187
Dose levels will be individually optimized.
Other Names:
  • Carbidopa-Levodopa Enteral Suspension
  • LCIG
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.

  Eligibility

Ages Eligible for Study:   30 Years to 99 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02799381

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

Locations
United States, Florida
Parkinson's Disease Treatment Center of SW Florida /ID# 150095 Recruiting
Port Charlotte, Florida, United States, 33980
United States, Louisiana
Ochsner Clinic Foundation /ID# 150093 Not yet recruiting
New Orleans, Louisiana, United States, 70121
United States, Texas
Central Texas Neurology Consultants /ID# 150088 Recruiting
Round Rock, Texas, United States, 78681
Greece
Mediterraneo Hospital /ID# 150955 Recruiting
Glyfada, Greece, 16675
University Hospital of Heraklion /ID# 150956 Recruiting
Heraklion, Greece, 71110
University Hospital of Ioannina, Neurology Clinic /ID# 150954 Recruiting
Ioannina, Greece, 45500
Italy
Azienda USL Toscana Centro /ID# 150770 Recruiting
Firenze, Italy, 50012
AOU Policlinico SUN - Seconda University of Naples /ID# 150851 Not yet recruiting
Naples, Italy, 80138
Policlinico Campus Bio-Medico /ID# 150846 Not yet recruiting
Rome, Italy, 00128
Fondazione Policlinico Tor Vergata di Roma /ID# 151167 Not yet recruiting
Rome, Italy, 00133
Slovakia
Univerzitna Nemocnica Bratislava - Nemocnica Ruzinov /ID# 150171 Not yet recruiting
Bratislava, Slovakia, 826 06
Univerzitna nemocnica Bratislava /ID# 150144 Not yet recruiting
Bratislava, Slovakia, 833 05
Univerzitna nemocnica L. Pasteura Kosice /ID# 150146 Not yet recruiting
Kosice, Slovakia, 041 66
Univerzitna nemocnica Martin /ID# 150145 Recruiting
Martin, Slovakia, 036 59
Spain
Hospital General Universitario de Elche /ID# 150154 Recruiting
Elche, Alicante, Spain, 03202
Hospital Universitario de la Princesa /ID# 150157 Not yet recruiting
Madrid, Spain, 28006
Hospital General Universitario Gregorio Maranon /ID# 150155 Not yet recruiting
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal /ID# 150152 Recruiting
Madrid, Spain, 28034
Hospital Universitario Virgen Macarena /ID# 158861 Not yet recruiting
Sevilla, Spain, 41009
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Lou Barbato, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02799381     History of Changes
Other Study ID Numbers: M15-535
2016-001403-23 ( EudraCT Number )
Study First Received: June 10, 2016
Last Updated: June 28, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AbbVie:
efficacy
carbidopa
levodopa
levodopa-carbidopa intestinal gel

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 21, 2017