Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease

Idiopathic Parkinson's Disease Clinical Trial

— NEUPAD  

Official title:

A Multicenter, Non-interventional Study With Neupro® to Evaluate the Perception of Pain Associated With Idiopathic Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606670
• Other study ID #: SP1058
• Status: Completed
• First received: May 22, 2012
• Last updated: March 9, 2018
• Start date: May 2012
• Est. completion date: July 2014

Study information

• Verified date: March 2018
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to evaluate the perception of pain associated with Parkinson´s Disease in patients who receive Neupro® for the first time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The decision by the treating physician to treat a patient with Neupro® for the first time is made before the patient's participation in this Non-Interventional Study (NIS)

• A Patient Data Consent form is signed and dated by the patient

• Male and female patients that suffer from pain associated with idiopathic Parkinson's Disease according to the physician's assessment

• Patients have not been treated with Rotigotine in the past

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Locations

Country	Name	City	State
Austria	61	Feldbach
Austria	60	Linz
Germany	16	Altenholz
Germany	5	Alzenau
Germany	22	Bad Honnef
Germany	26	Bad Krozingen
Germany	10	Berlin
Germany	4	Dresden
Germany	34	Düsseldorf
Germany	38	Erbach
Germany	24	Freiburg
Germany	1	Gera
Germany	3	Goettingen
Germany	32	Hamburg
Germany	2	Heidenheim
Germany	20	Köln
Germany	11	Konigsbruck
Germany	15	Mühldorf Am Inn
Germany	33	Münster
Germany	35	Osnabrück
Germany	31	Ruesselsheim
Germany	7	Schriesheim
Germany	44	Senftenberg
Germany	12	Stadtroda
Germany	13	Ulm
Germany	41	Westerstede
Germany	37	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (1)

Timmermann L, Oehlwein C, Ransmayr G, Fröhlich H, Will E, Schroeder H, Lauterbach T, Bauer L, Kassubek J. Patients' perception of Parkinson's disease-associated pain following initiation of rotigotine: a multicenter non-interventional study. Postgrad Med. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire	The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF).; The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable).; 8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain.; The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable.	From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Secondary	Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II	The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living'. It consists of 13 questions, each ranging from 0 (none) to 4 (severe abnormalities). The sum score of the UPDRS Part II ranges from 0 (normal) to 52 (worst score possible).	From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Secondary	Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III	The UPDRS is a scale for the assessment of function in Parkinson's disease. Part III measures 'Motor Function'. It consists of 14 items with 27 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part III ranges from 0 (normal) to 108 (worst score possible).	From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Secondary	Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III	The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living' and Part III 'Motor Function'. They consist of 40 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part II+III ranges from 0 (normal) to 160 (worst score possible).	From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Secondary	Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score	The PDQ-8 is a self-administered 8 item questionnaire that assesses the overall health status. The questions will be rated from 0 (never) to 4 (always [or cannot do at all]). The total score ranges from 0 (never) to 32 (always [or cannot do at all]) with lower scores indicating a better health status.	From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

External Links

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