Completed · registry statusSafety and Tolerability Trial of Switching From Ropinirole to Rotigotine
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Testing a treatment or activity · Study reference: NCT00593606
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Results reported
- Start (reported date)
- 2007-07
- Main measurements finished (reported actual date)
- 2007-12
- Study finished (reported actual date)
- 2007-12
Planned dates can move. A study finishing does not tell us when a paper will be published.
Read the results reported in the registry ↗
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease
This paper mentions the study ID; the relationship needs review · 2011
Kim HJ, Jeon BS, Lee WY, Lee MC, Kim JW, Kim JM, Ahn TB, Cho J, Chung SJ, Grieger F, Whitesides J, Boroojerdi B. Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease. BMC Neurol. 2011 Aug 10;11:100. doi: 10.1186/1471-2377-11-100. ↗
Registry results reference
Participation rules recorded for this study
Age 18 years and over · Also accepts healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Inclusion Criteria:
* Subject is informed and given ample time and opportunity to think about his/her participation in this trial and has given his/her written informed consent.
* Subject is willing and able to comply with all trial requirements.
* Subject is male or female, aged≥ 18 years.
* Subject is Korean.
* Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV) as defined by the cardinal sign, bradykinesia, and at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes.
* Subject is not satisfactorily controlled on a total daily dose of ropinirole from 3mg to 12mg, inclusive.
* If the subject is receiving levodopa, either short-acting or sustained-release (in combination with benserazide or carbidopa), the total daily dose must be stable for 28 days prior to the Baseline Visit and must remain stable for the Treatment Period.
* If the subject is receiving an anticholinergic agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase B (MAO-B) inhibitor (eg, selegiline), a COMT inhibitor (eg, entacapone), 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 Treatment Period
Exclusion Criteria:
Subjects are not permitted to enroll in the trial if any of the following criteria are met:
* Subject has previously participated in a trial with rotigotine.
* Subject has participated in another trial of an investigational drug within 28 days prior to the Baseline Visit or is currently participating in another trial of an investigational drug.
* Subject has atypical Parkinsonian syndrome(s), including drug-induced Parkinsonian syndrome(s).
* Subject has dementia, active psychosis, or hallucinations (not due to antiparkinsonian medication).
* Subject is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine.
* Subject is currently receiving central nervous system (CNS) active therapy (eg, sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the trial.
* Subject has a history of seizures or stroke within 1 year, has had a Transient Ischemic Attack (TIA) within 12 months prior to enrollment, or a history of myocardial infarction within the last 6 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 ≥ 500ms at Pretreatment or Baseline (repeated measurements within 1 hour).
* Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to Baseline.
* Subject has a history of significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis.
* Subject has malignant neoplastic disease requiring therapy within 12 months prior to enrollment.
* Subject has a history of chronic alcohol or drug abuse within the last 6 months.
* Subject has taken herbal medicine therapy within the last 2 weeks prior to the Baseline Visit.
* Subject has clinically significant laboratory results that, in the judgment 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 1 barrier method), or (iii) not sexually abstinent or (iv) not at least 2 years postmenopausal.
* Subject has evidence of an impulse control disorder according to the Jay Modified Minnesota Impulsive Disorders Interview (mMIDI) at Pretreatment (Visit 1).
* Subject has any other clinically significant medical or psychiatric condition that would, in the judgment of the investigator, interfere with the subject's ability to participate in this trial.
Full study name & original research details
Official study title
A Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's Disease
Short title used by the registry
Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine
Original description
This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of switching from ropinirole therapy to the rotigotine transdermal system and its effect on symptoms in subjects with idiopathic Parkinson's disease
Conditions reported: Parkinson's Disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Rotigotine
- Phases
- PHASE3
- Sponsor
- UCB Pharma
- Start date reported by registry
- 2007-07 (Not reported)
Registry updated: 2014-10-02 · Status last verified by the registry submitter: 2011-10
Registry records retrieved 2026-10-12 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
No central contact is listed. Check the location contacts or the official registry record.
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
No locations reported. Ask the study team where participation is available.
The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.