Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With "Wearingoff" Phenomenon
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ClinicalTrials.gov Identifier: NCT03103399 |
Recruitment Status :
Completed
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
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Tracking Information | |||||
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First Submitted Date ICMJE | March 28, 2017 | ||||
First Posted Date ICMJE | April 6, 2017 | ||||
Last Update Posted Date | April 6, 2017 | ||||
Actual Study Start Date ICMJE | September 26, 2006 | ||||
Actual Primary Completion Date | September 21, 2007 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change from baseline in absolute "off" time (time with poor mobility or complete immobility) at Visit V7 [ Time Frame: 8 weeks ] Baseline values for all efficacy variables were the values from Visit V3, and change from baseline refers to absolute change from baseline at Visit 7 (end of the 8-week treatment period)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With "Wearingoff" Phenomenon | ||||
Official Title ICMJE | A Multicentre, Double-blind, Randomised, Active- and Placebo-controlled Trial to Investigate the Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With "Wearingoff" Phenomenon Treated With Levodopa/Carbidopa or Levodopa/Benserazide | ||||
Brief Summary | The purpose of this study was to investigate the effect on the "wearing-off" phenomenon of 3 different doses of nebicapone (NEB 50 mg, 100 mg and 150 mg), compared with entacapone and placebo when dministered concomitantly with existing treatment with levodopa plus a dopa decarboxylase inhibitor (DDCI: carbidopa or benserazide). | ||||
Detailed Description | The study was conducted in 40 sites in Europe and South America: Argentina (6); Austria (2); Brazil (5); France (1); Hungary (4); Poland (7); Portugal (2); Romania (7); and Ukraine (6). Multicentre study with a screening visit (Visit V1), a single-blind placebo run-in period of 1 or 2 weeks (Period 1, Visits V2 to V3), and an 8-week randomised, double-blind, activeand placebo-controlled, parallel-group (5 groups) treatment period (Period 2, Visits V3 to V7). In Hungary only: a 1-week tapering-off period was added by amendment #1HU. The dosage of nebicapone was to be tapered off stepwise during 6 days. This period was to end with a follow-up Visit V8. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Parkinson Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
254 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | September 21, 2007 | ||||
Actual Primary Completion Date | September 21, 2007 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: At Visit V1 (screening), patients had to be/have:
At Visit V2 (entry to Period 1), patients had to have the results of laboratory tests acceptable by the investigator (not clinically relevant for the well being of the patient or for the purpose of the study). At Visit V3 (randomisation), patients had to have:
Exclusion Criteria: At Visit V1 (screening), patients were not to be/have:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03103399 | ||||
Other Study ID Numbers ICMJE | BIA-3202-202 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Bial - Portela C S.A. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Bial - Portela C S.A. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Bial - Portela C S.A. | ||||
Verification Date | March 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |