Parkinson's DiseasePhase 2PARROTNCT02103465
Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease
A Phase 2 study testing Rotigotine in people with Parkinson's Disease, run by Azienda Ospedaliera Cardinale G. Panico at 11 sites in Italy.
Trial summary
This exploratory trial will fulfill a medical data gap for the dopamine-agonist rotigotine, as so far no data on elderly population is available. Primary objective: To assess efficacy and safety of rotigotine in patients with late onset Parkinson's Disease (PD), starting at age 70 or later, on motor symptoms. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Rotigotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 11 sitesItaly
- Study dates
- Dec 2013to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥70 years
- Idiopathic Parkinson's Disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity
- Diagnosis of Parkinson's Disease (PD) within the last 12 months and onset of symptoms within 12 months from diagnosis
- Disease stage I or II according to Hoehn and Yahr Scale
- Ability to provide written informed consent
- Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Who cannot join
- Disease duration more than 12 months since diagnosis and/or duration of symptoms at diagnosis for more than 12 months
- Hoehn \& Yahr stage ≥3
- Atypical or secondary parkinsonism
- Patient currently on L-dopa, Dopamine Agonist (DA) or other Parkinson's Disease (PD) medication at baseline
- Centrally acting dopaminergic agents, monoamine oxidase inhibitors (MAOIs), tolcapone, budipine, neuroleptics taken within the 28 days preceding the baseline visit
- History of deep brain stimulation
Show all 20Show fewer
- History of severe cardiac disease/heart failure in the last 3 years
- History of repeated falls
- History of sulfite sensitivity
- Arterial hypotension
- Stroke or a transient ischemic attack within the last 12 months
- Previous or current treatment with rotigotine (at any time)
- Diagnosis of dementia according to Diagnostic and Statistic Manual (DSM)-IV-Revised
- Mini Mental State Examination (MMSE) total score <24 at screening visit
- History of psychosis
- Clinically relevant hepatic dysfunction and/or transaminase levels 5+ times higher than upper normal value
- Experimental treatments within the antecedent 3 months
- History of drug or alcohol dependency
- Poor compliance with treatment
- Inability to comply with protocol
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, Bari, 70021
Ospedale Lorenzo Bonomo Andria
Andria, Andria-Barletta-Trani, 76123
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, Bari, 70124
Ospedale "A. Perrino"
Brindisi, Brindisi, 72100
Ospedale Francesco Ferrari
Casarano, Lecce, 73042
A.O. Universitaria "Ospedali Riuniti" - U.O. Neurologia Ospedaliera
Foggia, Foggia, 71100
A.O. Universitaria "Ospedali Riuniti"-U.O. Neurologia Universitaria
Foggia, Foggia, 71100
Presidio Ospedaliero "Vito Fazzi"
Lecce, Lecce, 73100
Ospedale S. Giacomo
Monopoli, Bari, 70043
IRCCS "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, Foggia, 71013
A.O. Ospedale "Card. G. Panico" di Tricase
Tricase, Lecce, 73039
About this study
Official title: Late Onset Parkinson's Disease in Subjects 70 Years and Older: Possible Use of Rotigotine
This exploratory trial will fulfill a medical data gap for the dopamine-agonist rotigotine, as so far no data on elderly population is available.
Primary objective: To assess efficacy and safety of rotigotine in patients with late onset Parkinson's Disease (PD), starting at age 70 or later, on motor symptoms.
Read more
Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset Parkinson's Disease (PD), starting at age 70 or later, on selected non motor symptoms : sleep quality; depression; cognitive function.
Subjects ≥70 years, with diagnosis of Parkinson's Disease (PD) based on the presence of at least two of three cardinal features (bradykinesia, resting tremor, rigidity), within 12 months since diagnosis and no longer than 12 months from onset to diagnosis, and for whom the caring physician is uncertain on whether or not to start treatment.
Outcome Measurement: Percentage of Responders to treatment in motor (part III) and Activities of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale (UPDRS) at visit 4 and 6; Percentage of Responders to treatment in sleep quality in relation to Parkinson's Disease Sleep Scale (PDSS)-2 at visit 4 and 6; Responders to treatment in mood in relation to Geriatric Depression Scale (GDS) at visit 4 and 6.
Exploratory, randomized, double blind, placebo-controlled study: 80 patients with late onset Parkinson's Disease (PD) are randomized in 2 parallel groups, ratio 1:1.
One group will be treated with rotigotine and one group will be treated with placebo, for 12 weeks after titration.
Read the detailed description
Treatment is titrated to optimal dose (that at which investigator and subject felt that motor and non motor impairment are adequately controlled), starting at 2 mg/24 hr and increasing with weekly increments of 2 mg/24 hr up to a maximum of 8 mg/24 hr. The dose is maintained at the optimal or maximal dose for a 8-week period (maintenance period) .
- Conditions
- Parkinson's Disease
- Being tested
- Rotigotine, Placebo
- Keywords
- Parkinson's Disease, treatment, old patients, Rotigotine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotigotineDrug
Also called Neupro
transdermal patch
PlaceboDrug
transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine | Experimental | 80 patients with late onset PD are randomized in 2 parallel groups, ratio 1:1. Receives: Drug: Rotigotine |
| Placebo | Placebo comparator | 80 patients with late onset PD are randomized in 2 parallel groups, ratio 1:1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders to treatment (*) in motor (part III) and Activities of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale (UPDRS) at visit 4 and 6
(*) Responder to treatment is a subject who has at least a 20% decrease in the sum of scores (parts II and III) from the Unified Parkinson's Disease Rating Scale (UPDRS) subtotal from baseline to the end of the maintenance phase in the direction of normality.
The outcome will be valuate on Month 2 and Month 4
Measured: M2
Secondary outcomes (1)
Percentage of Responders to treatment in sleep quality in relation to Parkinson's Disease Sleep Scale-2 (PDSS) at visit 4 and 6
(*) Responder to treatment is a subject who has at least a 20% decrease in the sum of scores (parts II and III) from the Unified Parkinson's Disease Rating Scale (UPDRS) subtotal from baseline to the end of the maintenance phase in the direction of normality The outcome will be valuate on Month 2 and Month 4
Measured: M2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Because the rate of recruitment was very slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Cardinale G. Panico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giancarlo Logroscino, Prof, Study chair, A.O. Ospedale "Card G. Panico" di Tricase
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103465
- Sponsor's protocol ID
- EudraCT Number: 2013-000827-15
- Acronym
- PARROT
- Status last verified
- Jan 2016
- First submitted
- 26 Mar 2014
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Onset Parkinson's Disease in Subjects 70 Years and Older: Possible Use of Rotigotine
- ClinicalTrials.gov ID
- NCT02103465
- Acronym / sponsor ID
- PARROT / EudraCT Number: 2013-000827-15
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, treatment, old patients, Rotigotine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because the rate of recruitment was very slow
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory trial will fulfill a medical data gap for the dopamine-agonist rotigotine, as so far no data on elderly population is available.
Primary objective: To assess efficacy and safety of rotigotine in patients with late onset Parkinson's Disease (PD), starting at age 70 or later, on motor symptoms.
Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset Parkinson's Disease (PD), starting at age 70 or later, on selected non motor symptoms : sleep quality; depression; cognitive function.
Subjects ≥70 years, with diagnosis of Parkinson's Disease (PD) based on the presence of at least two of three cardinal features (bradykinesia, resting tremor, rigidity), within 12 months since diagnosis and no longer than 12 months from onset to diagnosis, and for whom the caring physician is uncertain on whether or not to start treatment.
Outcome Measurement: Percentage of Responders to treatment in motor (part III) and Activities of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale (UPDRS) at visit 4 and 6; Percentage of Responders to treatment in sleep quality in relation to Parkinson's Disease Sleep Scale (PDSS)-2 at visit 4 and 6; Responders to treatment in mood in relation to Geriatric Depression Scale (GDS) at visit 4 and 6.
Exploratory, randomized, double blind, placebo-controlled study: 80 patients with late onset Parkinson's Disease (PD) are randomized in 2 parallel groups, ratio 1:1.
One group will be treated with rotigotine and one group will be treated with placebo, for 12 weeks after titration.
Detailed description
Treatment is titrated to optimal dose (that at which investigator and subject felt that motor and non motor impairment are adequately controlled), starting at 2 mg/24 hr and increasing with weekly increments of 2 mg/24 hr up to a maximum of 8 mg/24 hr. The dose is maintained at the optimal or maximal dose for a 8-week period (maintenance period) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotigotine | Experimental | Drug: Rotigotine80 patients with late onset PD are randomized in 2 parallel groups, ratio 1:1. |
| Placebo | Placebo comparator | Drug: Placebo80 patients with late onset PD are randomized in 2 parallel groups, ratio 1:1. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥70 years
- Idiopathic Parkinson's Disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity
- Diagnosis of Parkinson's Disease (PD) within the last 12 months and onset of symptoms within 12 months from diagnosis
- Disease stage I or II according to Hoehn and Yahr Scale
- Ability to provide written informed consent
Key exclusion criteria (20 listed)
- Disease duration more than 12 months since diagnosis and/or duration of symptoms at diagnosis for more than 12 months
- Hoehn \& Yahr stage ≥3
- Atypical or secondary parkinsonism
- Patient currently on L-dopa, Dopamine Agonist (DA) or other Parkinson's Disease (PD) medication at baseline
- Centrally acting dopaminergic agents, monoamine oxidase inhibitors (MAOIs), tolcapone, budipine, neuroleptics taken within the 28 days preceding the baseline visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RotigotineAlso: Neuprotransdermal patch | Drug | Rotigotine |
| Placebotransdermal patch | Drug | Placebo |
Primary outcome
Percentage of Responders to treatment (*) in motor (part III) and Activities of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale (UPDRS) at visit 4 and 6
Time frame: M2
(*) Responder to treatment is a subject who has at least a 20% decrease in the sum of scores (parts II and III) from the Unified Parkinson's Disease Rating Scale (UPDRS) subtotal from baseline to the end of the maintenance phase in the direction of normality. The outcome will be valuate on Month 2 and Month 4
1 secondary outcome
Percentage of Responders to treatment in sleep quality in relation to Parkinson's Disease Sleep Scale-2 (PDSS) at visit 4 and 6
Time frame: M2
Results and safety
The study was stopped early (reason given: Because the rate of recruitment was very slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giancarlo Logroscino, Prof study chair
A.O. Ospedale "Card G. Panico" di Tricase
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rotigotine in people with Parkinson's Disease, run by Azienda Ospedaliera Cardinale G. Panico at 11 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Because the rate of recruitment was very slow). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Responders to treatment (*) in motor (part III) and Activities of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale (UPDRS) at visit 4 and 6 (time frame: M2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.