A randomized, placebo-controlled, double-blind, multi-centre trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA

Overview
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Transatlantic, multi-center, placebo-controlled, randomized, double-blind clinical trial to demonstrate that transdermal nicotine treatment retards parkinson's disease progression as measured by change in total (part I, II, III) UPDRS score between baseline and after 52 weeks of study treatment plus two more months wash out (60 weeks).

Sponsor: Philipps-University Marburg

SEEK ID: https://ldh.kks-marburg.imise.uni-leipzig.de/projects/5

Public web page: Not specified

NFDI4Health PIs: No PIs for this Trial Project

Trial Project start date: 17th Oct 2012

Trial Project end date: 15th Sep 2016

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : 29559

Resource classification(*)

Type of the resource(*) : Study

Title(s)/name(s) of the Project

Title/name(*) : A randomized, placebo-controlled, double-blind, multi-centre trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA
Language of the title/name(*) : English

Acronym(s) of the Project

Acronym(*) : NIC-PD
Language of the acronym(*) : English

Description(s) of the Project

Description(*) : Transatlantic, multi-center, placebo-controlled, randomized, double-blind clinical trial to demonstrate that transdermal nicotine treatment retards parkinson's disease progression as measured by change in total (part I, II, III) UPDRS score between baseline and after 52 weeks of study treatment plus two more months wash out (60 weeks).
Language of the description(*) : English

Keyword(s) describing the Project

Keyword(*) : transdermal nicotine treatment

Keyword(*) : Parkinson's Disease

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (secondary)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Philipps-University Marburg/KKS
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : info@kks.uni-marburg.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Philipps-University Marburg/KKS
Address : Karl-von-Frisch-Str. 4, 35043 Marburg
Web page : https://www.kks.uni-marburg.de
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : EudraCT
Identifier(*) : 2010-020299-42

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Parkinson's Disease
Terminology/classification(*) : ICD-10
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the nervous system (VI)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : No
Start date : 17 October 2012
End date : 15 September 2016
Mono- or multicentric? : Multicentric
Number of centers : 14
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 30
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 99
Unit of age(*) : Years
Eligible gender : Male, Female
Inclusion criteria : see protocol
Exclusion criteria : see protocol
Population of the Project(*)
Coverage : International
Country(ies) : Germany, United States
Region(s) and/or city(ies) : nationwide
Interventions of the Project
Name of the intervention(*) : Transdermal nicotine patch (7 to 28 mg/day, highest well-tolerated dose)
Type of the intervention : Combination product (combining a drug and device, a biological product and device; a drug and biological product; or a drug, biological product, and device)
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Experimental
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : disease-modifying potential of transdermal nicotine treatment
Description of the outcome measure : The primary endpoint is calculated as the difference between the nicotine arm and the placebo arm in the change in total UPDRS I-III score between baseline and 60 weeks (14 months) (52 weeks treatment plus 8 weeks wash-out).
Type of the outcome measure : Primary
Time point(s) of assessment : 2-12 months
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : Not specified
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-2
Masking of intervention(s) assignment
Masking implemented? : true
Who is masked? : Participant, Care provider
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : Not specified

A randomized, placebo-controlled, double-blind, multi-centre trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA

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