| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Idiopathic Parkinson's disease |
|
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To assess the effect of rotigotine on the control of early morning motor impairment and sleep disorders in subjects with idiopathic Parkinson's disease. |
|
| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
- 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 </=85 years.
- Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV; see
Section 15.9) 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.
|
|
| E.4 | Principal exclusion criteria |
- 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.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Motor performance:
•Decrease in early morning motor impairment from Baseline to the end of
Maintenance as measured in the morning before patch application using the UPDRS
Part III (Motor Examination) score
•Change from Baseline to end of Maintenance in tapping rate as measured in the
morning before patch application
•Change from Baseline to end of Maintenance in standing-walking-turning test
before the morning patch application
•Improvement in nocturnal akinesia as measured by change from Baseline to end of
Maintenance in Nocturnal Akinesia Score
Sleep disorders:
•Change from Baseline to end of Maintenance in Parkinson's Disease Sleep Scale
(PDSS)
•Change from Baseline to end of Maintenance in Epworth Sleepiness Scale (ESS)
•Change from Baseline to end of Maintenance in Nocturnal Akinesia, Dystonia, and
Cramps Score (NADCS)
•Change from Baseline to end of Maintenance in number of nocturias
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Information not present in EudraCT |
| E.6.4 | Safety | Information not present in EudraCT |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Information not present in EudraCT |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Information not present in EudraCT |
| E.8.1.5 | Parallel group | Information not present in EudraCT |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The end of the trial is defined as the date of the last visit of the last patient participating the trial. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | |
| E.8.9.1 | In the Member State concerned days | |
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