Study to Evaluate Initiation of Stalevo in Early Wearing-off (SENSE)

Efficacy and Safety of Stalevo® in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9; an Open, Non-randomised, Multinational, Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinson's Disease Patients

An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will be determined by the subject's current, separately administered standard levodopa/DDCI treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of Stalevo® without changing the number of doses per day. The levodopa daily dose during Stalevo® treatment may be adjusted according to the study subject's clinical response.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Stalevo

Detailed Description

See 'Brief summary'.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10098
    • Humboldt Universität Charité Neurologische Klinik
  • Bochum, Germany, 44791
    • St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik
  • Chemnitz, Germany, 09111
    • Pharmakologisches Studienzentrum Chemnitz
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie
  • Erbach, Germany, 64711
    • Gemeinschaftspraxis für Neurologie & Psychiatrie
  • Giessen, Germany, 35390
    • Neurologische Praxis Dr Christine Schuster
  • Hamburg, Germany, 20251
    • Universitätskrankenhaus Eppendorf
  • Kassel, Germany, 34128
    • Paracelsus-Elena Klinik
  • Krefeld, Germany, 47805
    • Alexianer-Krankenhaus
  • Köln, Germany, 51069
    • Nervenarztpraxis Dr Alexander Nass
  • Marburg, Germany, D-35039
    • Universitätsklinikum Gießen und Marburg GmbH
  • Stadtroda, Germany, 07646
    • Asklepios Fachklinikum Stadtroda
  • Tübingen, Germany, 72076
    • Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie
  • Ulm, Germany, 89081
    • Neurologische Klinik der Universität Ulm
• Sweden
  • Jönköping, Sweden, 55185
    • Länsjukhuset Ryhov, Geriatriska Kliniken
  • Nyköping, Sweden, 61185
    • Nyköpings Lasarett, Ger/Rehabkliniken
  • Visby, Sweden, 62184
    • Visby lasarett, Neurologmottagningen
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Royal Sussex County Hospital, Neurology Department
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • The Royal Bournemouth Hospital, Department of Medicines for the Elderly
  • Tyne and Wear
    • North Shields, Tyne and Wear, United Kingdom, NE29 8NH
      • North Tyneside General Hospital, Department of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with idiopathic Parkinson's disease and early wearing-off symptoms treated with standard levodopa/DDCI treatment
• Age >35 - years
• Hoehn and Yahr stage 1-3 performed during the 'ON'-stage
• At least 1 symptom identified by WOQ-9
• Dosing frequency of 3-4 doses of standard-release levodopa/DDCI (maximum total daily dose of 600 mg of levodopa)

Exclusion Criteria:

• Atypical or symptomatic Parkinson's disease
• Unpredictable OFF-periods
• Any peak-dose dyskinesia. 'OFF'-state dystonia is allowed
• Use of any rescue medications to treat symptoms of 'OFF'-state. 1 dose of soluble levodopa/DDCI is allowed.
• Concomitant treatment with non-selective monoamine oxidase (MAO) inhibitor or simultaneous use of higher than recommended doses of MAO-A and MAO-B inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Stalevo	Drug: Stalevo; Oral 3-4 daily doses for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Global Impression of Change (Patient)	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Global Impression of Change (Investigator); United Parkinson's Disease Rating Scale (II, III); Quality of Life Visual Analogue Scale; Wearing-off Questionnaire with 9 symptoms	6 weeks

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Investigators: Principal Investigator: Wolfgang H. Oertel, Professor, Universitätsklinikum Gießen und Marburg GmbH

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (ACTUAL): August 1, 2007
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: April 17, 2007
• First Submitted That Met QC Criteria: April 17, 2007
• First Posted (ESTIMATE): April 18, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2939117