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)
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|ClinicalTrials.gov Identifier: NCT02799381|
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : April 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Parkinson's Disease||Drug: ABT-SLV187 Drug: optimized antiparkinsonian treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 13, 2017|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
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.
12 Week Period
Dose levels will be individually optimized.
Other Name: Carbidopa-Levodopa Enteral Suspension LCIG
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: ABBVIE CALL CENTERemail@example.com|
|United States, Florida|
|Parkinson's Disease Treatment Center of Southwest Florida||Recruiting|
|Port Charlotte, Florida, United States, 33980|
|United States, Texas|
|Central Texas Neurology Consul||Recruiting|
|Round Rock, Texas, United States, 78681|
|Helsinki Univ Central Hospital||Recruiting|
|Helsinki, Finland, 00290|
|Oulun yliopistollinen sairaala||Recruiting|
|Oulu, Finland, 90220|
|University Hospital of Heraklion||Recruiting|
|Heraklion, Kriti, Greece, 711 10|
|Mediterraneo Hospital||Active, not recruiting|
|Glyfada, Greece, 16675|
|University Hospital of Ioannin||Recruiting|
|Ioannina, Greece, 45500|
|Policlinico Universitario Campus Bio-Medico||Recruiting|
|Rome, Lazio, Italy, 00128|
|A.O. Univ. Ospedali Riuniti||Not yet recruiting|
|Ancona, Marche, Italy, 60126|
|Azienda USL Toscana Centro||Recruiting|
|Florence, Italy, 50012|
|Seconda Universita' di Napoli||Recruiting|
|Naples, Italy, 80138|
|Policlinico Tor Vergata||Recruiting|
|Rome, Italy, 00133|
|Univerzitna nemocnica Martin||Not yet recruiting|
|Martin, Trnavsky Kraj, Slovakia, 036 01|
|Univerzitna Nemocnica Bratisla||Recruiting|
|Bratislava, Slovakia, 821 01|
|Univerzitna nemocnica L. Paste||Recruiting|
|Kosice, Slovakia, 041 66|
|Hospital General Univ de Elche||Recruiting|
|Elche, Spain, 03202|
|Hospital Univ de la Princesa||Recruiting|
|Madrid, Spain, 28006|
|Hospital General Universitario Gregorio Maranon||Not yet recruiting|
|Madrid, Spain, 28009|
|Hospital Univ Ramon y Cajal||Not yet recruiting|
|Madrid, Spain, 28034|
|Hospital Universitario Infanta||Not yet recruiting|
|Madrid, Spain, 28702|
|Hospital Universitario Virgen Macarena||Recruiting|
|Sevilla, Spain, 41009|
|Hospital Virgen de la Salud||Not yet recruiting|
|Toledo, Spain, 45005|
|Study Director:||AbbVie Inc.||AbbVie|