STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976

• Register: EUCTR
• Last refreshed on: 7 January 2013
• Main ID: EUCTR2010-021394-37-IT
• Date of registration: 28/12/2011
• Prospective Registration: No
• Primary sponsor: UCB Pharma SA
• Public title: STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976
• Scientific title: STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976
• Date of first enrolment: 01/03/2011
• Target sample size: 345
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021394-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Austria, Belgium, Czech Republic, Germany, Hungary, Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC)approved written Informed Consent form is signed and dated by the subject or legal representative. 2. Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule and medication intake according to the judgment of the investigator. 3. Subject is male or female, = 18 years of age. 4. Subject has idiopathic Parkinson’s disease with at least two(2) or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of Parkinsonism. 5. Subject has a Hoehn and Yahr stage score = 4. 6. Subject has a total NMSS = 40 UCB Final 28Sep2010 Protocol Summary Rotigotine SP0976 Confidential Page 6 of 14 7. If the subject is receiving anticholinergics, monoamine oxidase B (MAO-B) or amantadine, he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the duration of the trial. 8. If subject is taking levodopa (L-DOPA), he/she must be on a stable dose of L-DOPA (in combination with benserazide or carbidopa) for at least 28 days prior to the Baseline Visit. 9. Female subjects of childbearing potential must agree to practice an adequate contraception method.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study. 2. Subject has participated in another study of an IMP within 30 days prior to the Screening Period or is currently participating in another study of an IMP. 3. Subject has a history of chronic alcohol or drug abuse within the previous year. 4. Subject has any medical, psychiatric, or cognitive condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s well being or ability to participate in this study. 5. Subject has a known hypersensitivity to any components of the IMP, including sodium metabisulfite. 6. Subject has a significant skin disease that would make transdermal drug use inappropriate, including a history of skin sensitivity to adhesives or transdermal medications. 7. Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator. 8. Subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), MAO-A inhibitors, methylphenidate, amphetamine, or other dopamine agonists (DAs). 9. Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the study. 10. Subject has evidence of an ICD according to the mMIDI at the Screening Visit (Visit 1), confirmed by a positive structured clinical interview.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

subjects with Parkinson’s disease.
MedDRA version: 14.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: NEUPRO
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
Concentration unit: mg milligram(s)
Concentration number: 4.5-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Trade Name: NEUPRO
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
Concentration unit: mg milligram(s)
Concentration number: 9-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Trade Name: NEUPRO
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
Concentration unit: mg milligram(s)
Concentration number: 13.5-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Trade Name: NEUPRO
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
Concentration unit: mg milligram(s)
Concentration number: 18-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Primary Outcome(s)

Main Objective: The primary objective of this study is to demonstrate that rotigotine improves nonmotor symptoms compared to placebo in subjects with Parkinson’s disease.

Primary end point(s): Primary efficacy variable: Change from Baseline to the end of Maintenance in total NMSS score Secondary efficacy variables: Change from Baseline to the end of Maintenance in total UPDRS Part III score • Change from Baseline to the end of Maintenance in HRQL measured by PDQ39 • Change from Baseline to the end of Maintenance in each subdomain of the NMSS score: • cardiovascular •Sleep/Fatigue •Mood/Cognition •Perception/Hallucinations •Attention/Memory •Gastrointestinal Tract •Urinary •Sexual Function •Miscellaneous Other efficacy variables •Clinical Global Impression Scale (CGIS): subscale CGI-improvement •Patients’s Global Impression (PGI): subscale Global Improvement Safety variables •Occurrence of adverse events (AEs) •Vital sign parameters (heart rate, blood pressure) •Modified Minnesota Impulsive Disorder Interview (mMIDI)

Secondary Objective: The secondary objective is to demonstrate that rotigotine is effective on motor symptoms and improves HRQL compared to placebo in subjects with Parkinson’s disease.

Secondary ID(s)

2010-021394-37-DE

SP0976