A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease
- Conditions
- Parkinson's Disease
- Registration Number
- EUCTR2004-002609-66-DE
- Lead Sponsor
- Schwarz Biosciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
- Subject is informed and given ample time and opportunity to think about his/her
participation and has given his/her written informed consent.
- Subject is willing and able to comply with all trial requirements.
- Subject is male or female, =18 years.
- Subject has idiopathic early-stage Parkinson's disease (Hoehn & Yahr Stage I-III;
see Section 15.9) =5 years in duration, with at least two (2) or more of the
following cardinal signs being present: bradykinesia, resting tremor, rigidity,
postural instability; and without any other known or suspected cause of
Parkinsonism.
- Subject has a UPDRS motor score (part III) of =10 at baseline (Visit 2)
- Subject has unsatisfactory control of early morning motor impairment as
determined by the investigator.
- If the subject is receiving an anticholinergic agent (eg, benztropine,
trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase B (MAO-B)
inhibitor (eg, selegiline), or an n-methyl-d-aspartate (NMDA) antagonist (eg,
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.
Are the trial subjects under 18?
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Subject has previously participated in a trial with rotigotine.
- Subject has participated in another trial of an investigational drug within the last
28 days or is currently participating in another trial of an investigational drug.
- 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.
- Subject has had prior therapy with a dopamine agonist within 28 days prior to
Baseline.
- Subject is receiving therapy with levodopa within 28 days prior to baseline or is
receiving therapy with entacapone or tolcapone; subject has received levodopa for
more than 6 months since diagnosis.
- Subject is receiving therapy with one of the following drugs either concurrently or
within 28 days prior to Visit 2: dopamine agonists, alpha-methyl dopa,
metoclopramide, reserpine, budipine, neuroleptics (including atypical), MAO-A
inhibitors, methylphenidate, amphetamine, or central dopamine antagonists.
- Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in
the 6 months prior to baseline.
- Subject has atypical Parkinsonian syndromes (including drug-induced Parkinsonian
syndromes).
- Subject has a history of atopic eczema and/or active skin disease.
- Subject has dementia, active psychosis, or hallucinations (not due to
antiparkinsonian medication).
- Subject is receiving CNS therapy (eg, sedatives, hypnotics, selective serotonin
reuptake inhibitors [SSRIs], anxiolytics, other sleep-modifying medication) unless
dose has been stable daily for at least 28 days prior to baseline and is likely to
remain stable for the duration of the trial.
- Subject has a history of seizures or stroke within 12 months prior to enrollment, or
has had a TIA within 12 months prior to enrollment, or has a history of myocardial
infarction within the last 6 months prior to enrollment.
- Subject has malignant neoplastic disease requiring therapy within 12 months prior
to enrollment.
- Subject has clinically relevant hepatic dysfunction.
- Subject has clinically relevant renal dysfunction.
- Subject has relevant cardiovascular disorders.
- Subject has a QTcB interval of =500msec at Screening or Baseline (Visit 1 or 2;
repeated measurements within 1 hour).
- Subject has a history of chronic alcohol or drug abuse within the last 6 months.
- Subject has clinically relevant laboratory results that, in the opinion of the
investigator, would make the subject unsuitable for entry into the trial.
- Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically
sterile, or, (ii) not using adequate birth control methods (including at least one
barrier method) or, (iii) not sexually abstinent, or (iv) subject is not at least 2 years
post menopausal.
- Subject has any medical or psychiatric condition that, in the opinion of the
investigator, can jeopardize or would compromise the subject’s ability to participate
in this trial.
- Subject has a history of significant skin hypersensitivity to adhesive or other
transdermals or recent unresolved contact dermatitis or has a known allergy or
hypersensitivity to ropinirole.
- Subject has a previous diagnosis of narcolepsy, sleep apnea syndrome, rapid eye
movement (REM) behavior disorder, restless legs syndrome, or periodic limb
movement disorder.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method