A phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease
- Conditions
- Parkinson's Disease
- Registration Number
- EUCTR2004-002598-21-AT
- Lead Sponsor
- Schwarz Biosciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
- 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 of age and - Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV) as defined by the cardinal sign, bradykinesia, and at least one of the
following: resting tremor, rigidity, or impairment of postural reflexes.
- Subject has unsatisfactory control of early morning motor impairment as
determined by the investigator.
- If subject is taking levodopa, he/she must be on a stable dose of levodopa (in
combination with benserazide or carbidopa) for at least 28 days prior to the
Baseline visit.
- 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.
- Subject must understand the investigational nature of the trial and be willing and
able to comply with the trial requirements.
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
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 controlled-release levodopa within 28 days prior
to baseline or is receiving therapy with tolcapone.
- Subject is receiving therapy with one of the following drugs either concurrently or
within 28 days prior to Visit 2: alpha-methyl dopa, metoclopramide, reserpine,
neuroleptics (including atypical), monoamine oxidase A (MAO-A) inhibitors,
methylphenidate, or amphetamine.
- 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, such as atopic
eczema.
- Presence of 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 1 year, or a history of myocardial
infarction within the last 6 months prior to enrollment.
- Subject has neoplastic disease requiring therapy within 12 months prior to
enrollment.
- Presence of clinically relevant hepatic dysfunction.
- Presence of clinically relevant renal dysfunction.
- Evidence of clinically 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 significant 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 child bearing 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 two
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 known hypersensitivity to any components of the trial medication
stated in this protocol.
- 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