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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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10 December 2019 |
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Main ID: |
EUCTR2004-002598-21-GB |
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Date of registration:
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07/07/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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02/03/2005 |
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Target sample size:
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50 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002598-21 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled:
Randomised: no
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Austria
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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 - 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.
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
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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Idiopathic Parkinson's disease
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Intervention(s)
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Product Name: Rotigotine
Product Code: SPM 962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: [99755-59-6]
Current Sponsor code: SPM 962
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4.5-
Product Name: Rotigotine
Product Code: SPM 962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: [99755-59-6]
Current Sponsor code: SPM 962
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9.0-
Product Name: Rotigotine
Product Code: SPM 962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: [99755-59-6]
Current Sponsor code: SPM 962
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 13.5-
Product Name: Rotigotine
Product Code: SPM 962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: [99755-59-6]
Current Sponsor code: SPM 962
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18.0-
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Primary Outcome(s)
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Secondary Objective:
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Main Objective: To assess the effect of rotigotine on the control of early morning motor impairment and sleep disorders in subjects with idiopathic Parkinson's disease.
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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
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Secondary ID(s)
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2004-002598-21-AT
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SP826
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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