Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms

• Conditions: Parkinson's disease; MedDRA version: 14.1Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-021394-37-BG
• Lead Sponsor: CB Pharma SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-02
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 345

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 application 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 2 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 score =40.

7. If the subject is receiving anticholinergics, monoamine oxidase (MAO) B inhibitors, 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
study.

8. If the 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 use 1 of the following
contraceptive methods throughout the course of the study and for 4 weeks after
the final removal of study medication:
? Oral contraceptives
? Intrauterine devices
? Double-barrier method

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1. 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.

11. Subject is pregnant or lactating.
12. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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.;Primary end point(s): Change from Baseline to the end of Maintenance in total NMSS score<br>;Timepoint(s) of evaluation of this end point: From baseline to 12 weeks maintenance

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Change from Baseline to the end of Maintenance in total UPDRS Part III score<br>- Change from Baseline to the end of Maintenance in HRQL measured by the PDQ-39<br>- Change from Baseline to the end of Maintenance in each subdomain of the NMSS score;Timepoint(s) of evaluation of this end point: From baseline to 12 weeks maintenance