Idiopathic Parkinson's DiseasePhase 3PIVICOG-PDNCT01007864
Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists
A Phase 3 study testing piribedil and pramipexole or ropinirole in people with Idiopathic Parkinson's Disease, run by Desitin Arzneimittel GmbH at 12 sites in Germany.
Trial summary
The purpose of this clinical trial is to investigate the effects of the non-ergot dopamine agonist piribedil on vigilance and cognitive performances in patients with Parkinson's disease in comparison with other oral non-ergot dopamine agonists. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- piribedil and pramipexole or ropinirole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 12 sitesGermany
- Study dates
- Jan 2010to Dec 2011
- Phase
- Phase 3
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Caucasian patients aged 35 to 80 years;
- Patients with idiopathic Parkinson's disease;
- Hoehn \& Yahr stages 1 to 4;
- Stable medication with anti-parkinsonian medication, including stable treatment with pramipexole or ropinirole, for at least 4 weeks prior to Screening;
- Significant daytime sleepiness: Epworth Sleepiness Scale score equals or is higher than 11 under previous therapy with pramipexole or ropinirole;
- Patients who have read and understood the patient information sheet and have provided a signed written informed consent form;
- Patients are considered to be compliant to the study regimen.
Who cannot join
- Treatment of Parkinson's disease with any dopamine agonist other than pramipexole or ropinirole within 4 weeks prior to Screening;
- Known hypersensitivity to Clarium® or its excipients;
- Patients with daytime sleepiness caused by other factor's than Parkinson's disease, i.e., idiopathic narcolepsy, shift work, severe alcohol abuse, obstructive diseases, sleep apnea syndrome, or Periodic limb movement disorder;
- Secondary and atypical Parkinson syndrome;
- Depression (Beck Depression Inventory score higher than 16);
- Dementia (Mini-Mental State Examination score equals or is lower than 24);
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- Severe disability in extremities which could influence clinical assessments;
- Clinically significant disease concerning the lung, liver or kidney;
- Any acute or chronic infection that may influence the outcome of the study;
- Cardiovascular shock;
- Acute myocardial infarction;
- Congestive heart failure NYHA class III or IV;
- Uncontrolled arterial hypertension (diastolic blood pressure equals or is higher than 105 mmHg) or clinically relevant hypotension;
- Evidence of clinically active cancer;
- Color vision defect that may have impact on assessment of FWIT;
- History of substance abuse;
- Intake of benzodiazepines (or derivates) if not at stable dose for at least 4 weeks prior to Screening; intake of antiallergic agents (H1 receptor antagonists, except selective, non-sedating H1-antihistamines, e.g. loratadine and others), substances with psychostimulant properties (e.g., amphetamine, modafinil), or antidepressants if not at stable dose for at least 2 months prior to Screening;
- Current treatment with neuroleptic agents (except for clozapine);
- Female patients who are pregnant or lactating;
- Female patients of childbearing potential who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), e.g., implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner;
- Mental condition rendering the patient unable to understand the nature, scope and possible risks of the study;
- Patient has a history of or is suspicious of unreliability, poor co-operation or non-compliance with medical treatment;
- Patients are currently or previously (within the last 28 days) participating in another study of an investigational drug;
- Patients who were previously enrolled in this study;
- Patients with known Hepatitis B or C or HIV infection;
- Patients who are employees of the sponsor or patients who are employees or relatives of the investigator.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Study site
Berlin, State of Berlin, 12200
Study site
Berlin, State of Berlin, 13353
Study site
Dresden, Saxony, 01307
Study site
Gera, Thuringia, 07551
Study site
Göttingen, Lower Saxony, 37075
Study site
Leipzig, Saxony, 04107
Study site
Marburg, Hesse, 35043
Study site
München, Bavaria, 80804
Study site
Stadtroda, Thuringia, 07646
Study site
Steglitz, State of Berlin, 12163
Study site
Ulm, Baden-Wurttemberg, 89081
Study site
Wolfach, Baden-Wurttemberg, 77709
About this study
Official title: Influence of the Non-Ergot Dopamine Agonist Piribedil on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Oral Non-Ergot Dopamine Agonists
The purpose of this clinical trial is to investigate the effects of the non-ergot dopamine agonist piribedil on vigilance and cognitive performances in patients with Parkinson's disease in comparison with other oral non-ergot dopamine agonists.
It should be tested whether piribedil is superior to continued pramipexole or ropinirole treatment regarding improvement of reduced vigilance and cognitive performance in patients with Parkinson's disease.
Read the detailed description
Treatment of motor symptoms associated with PD by non-ergot dopamine agonists has been proven to be effective, both as monotherapy and in combination with levodopa. Non-motor symptoms like cognitive or sleep-related disorders and disturbed vigilance, however, are common in PD and can significantly worsen health and quality of life of the patient and family members. Some of these non-motor symptoms may also be caused by the antiparkinsonian medication per se. The Committee for Proprietary Medicinal Products (CPMP) initiated a review of dopamine agonists in relation to episodes of sudden onset of sleep already in 2000 which resulted in special warnings of somnolence and sudden sleep attacks in the non-ergot dopamine agonists' summary of product characteristics.
Beneficial effects of piribedil on parameters of vigilance and cognition have been described in several studies. But, as it seems, no study has been performed so far to identify such effects in the setting of a comparative study with different oral non-ergot dopamine agonists in patients with PD, and utilizing vigilance and cognitive parameters as primary and main secondary objective. The neuropsychological tests being applied in this study are validated and routinely used tests in studies investigating different aspects of attention or vigilance and cognition.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- piribedil, pramipexole or ropinirole
- Keywords
- Parkinson, piribedil, vigilance, dopamine agonist, cognition
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piribedilDrug
Also called Clarium®
Oral application of piribedil at an equivalent dose of pramipexole or ropinirole according to a defined equivalence scheme (dose range 100 - 300 mg per day) for 11 weeks.
pramipexole or ropiniroleDrug
continuation of pre-study treatment regimen
| Study group | Role | What they receive |
|---|---|---|
| piribedil | Experimental | Not described Receives: Drug: piribedil |
| pramipexole or ropinirole | Active comparator | Not described Receives: Drug: pramipexole or ropinirole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable will be the 'median reaction time during the second 15 minutes (minutes 16-30)' of the subtest 'vigilance', visual test condition 'moving bar', of the Test battery for Attention Performances (TAP) at end of treatment.
Measured: Baseline and End of Treatment
Secondary outcomes (8)
Other vigilance parameters of the TAP test
Measured: Baseline and End of Treatment
Other neuropsychological tests: Test of verbal fluency (RWT), Verbal learning memory test (VLMT), Stroop test (FWIT)
Measured: Baseline and End of Treatment
Epworth Sleepiness Scale (ESS)
Measured: Baseline and End of Treatment
Parkinson's Disease Sleeping Scale (PDSS)
Measured: Baseline and End of Treatment
Unified Parkinson's Disease Rating Scale (UPDRS) subscores I to IV and total score
Measured: Baseline and End of Treatment
Parkinson's disease quality of life questionnaire (PDQ-39)
Measured: Baseline and End of Treatment
Clinical Global Impressions (CGI) (except item 3.2)
Measured: End of Treatment
Patient Global Impression (PGI)
Measured: End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desitin Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Martina Wangemann, Dr., Study director, Desitin Arzneimittel GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007864
- Sponsor's protocol ID
- PIR-007/K
- Acronym
- PIVICOG-PD
- Status last verified
- Apr 2012
- First submitted
- 3 Nov 2009
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Non-Ergot Dopamine Agonist Piribedil on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Oral Non-Ergot Dopamine Agonists
- ClinicalTrials.gov ID
- NCT01007864
- Acronym / sponsor ID
- PIVICOG-PD / PIR-007/K
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson, piribedil, vigilance, dopamine agonist, cognition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Desitin Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Nov 2009 (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.
The purpose of this clinical trial is to investigate the effects of the non-ergot dopamine agonist piribedil on vigilance and cognitive performances in patients with Parkinson's disease in comparison with other oral non-ergot dopamine agonists.
It should be tested whether piribedil is superior to continued pramipexole or ropinirole treatment regarding improvement of reduced vigilance and cognitive performance in patients with Parkinson's disease.
Detailed description
Treatment of motor symptoms associated with PD by non-ergot dopamine agonists has been proven to be effective, both as monotherapy and in combination with levodopa. Non-motor symptoms like cognitive or sleep-related disorders and disturbed vigilance, however, are common in PD and can significantly worsen health and quality of life of the patient and family members. Some of these non-motor symptoms may also be caused by the antiparkinsonian medication per se. The Committee for Proprietary Medicinal Products (CPMP) initiated a review of dopamine agonists in relation to episodes of sudden onset of sleep already in 2000 which resulted in special warnings of somnolence and sudden sleep attacks in the non-ergot dopamine agonists' summary of product characteristics.
Beneficial effects of piribedil on parameters of vigilance and cognition have been described in several studies. But, as it seems, no study has been performed so far to identify such effects in the setting of a comparative study with different oral non-ergot dopamine agonists in patients with PD, and utilizing vigilance and cognitive parameters as primary and main secondary objective. The neuropsychological tests being applied in this study are validated and routinely used tests in studies investigating different aspects of attention or vigilance and cognition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| piribedil | Experimental | Drug: piribedil |
| pramipexole or ropinirole | Active comparator | Drug: pramipexole or ropinirole |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female Caucasian patients aged 35 to 80 years;
- Patients with idiopathic Parkinson's disease;
- Hoehn \& Yahr stages 1 to 4;
- Stable medication with anti-parkinsonian medication, including stable treatment with pramipexole or ropinirole, for at least 4 weeks prior to Screening;
- Significant daytime sleepiness: Epworth Sleepiness Scale score equals or is higher than 11 under previous therapy with pramipexole or ropinirole;
Key exclusion criteria (26 listed)
- Treatment of Parkinson's disease with any dopamine agonist other than pramipexole or ropinirole within 4 weeks prior to Screening;
- Known hypersensitivity to Clarium® or its excipients;
- Patients with daytime sleepiness caused by other factor's than Parkinson's disease, i.e., idiopathic narcolepsy, shift work, severe alcohol abuse, obstructive diseases, sleep apnea syndrome, or Periodic limb movement disorder;
- Secondary and atypical Parkinson syndrome;
- Depression (Beck Depression Inventory score higher than 16);
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 |
|---|---|---|
| piribedilAlso: Clarium®Oral application of piribedil at an equivalent dose of pramipexole or ropinirole according to a defined equivalence scheme (dose range 100 - 300 mg per day) for 11 weeks. | Drug | piribedil |
| pramipexole or ropinirolecontinuation of pre-study treatment regimen | Drug | pramipexole or ropinirole |
Primary outcome
The primary efficacy variable will be the 'median reaction time during the second 15 minutes (minutes 16-30)' of the subtest 'vigilance', visual test condition 'moving bar', of the Test battery for Attention Performances (TAP) at end of treatment.
Time frame: Baseline and End of Treatment
8 secondary outcomes
Other vigilance parameters of the TAP test
Time frame: Baseline and End of Treatment
Other neuropsychological tests: Test of verbal fluency (RWT), Verbal learning memory test (VLMT), Stroop test (FWIT)
Time frame: Baseline and End of Treatment
Epworth Sleepiness Scale (ESS)
Time frame: Baseline and End of Treatment
Parkinson's Disease Sleeping Scale (PDSS)
Time frame: Baseline and End of Treatment
Unified Parkinson's Disease Rating Scale (UPDRS) subscores I to IV and total score
Time frame: Baseline and End of Treatment
Parkinson's disease quality of life questionnaire (PDQ-39)
Time frame: Baseline and End of Treatment
Clinical Global Impressions (CGI) (except item 3.2)
Time frame: End of Treatment
Patient Global Impression (PGI)
Time frame: End of Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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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.
Martina Wangemann, Dr. study director
Desitin Arzneimittel GmbH
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing piribedil and pramipexole or ropinirole in people with Idiopathic Parkinson's Disease, run by Desitin Arzneimittel GmbH at 12 sites in Germany.
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 7 inclusion and 26 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: finished, as of the sponsor's last update on 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary efficacy variable will be the 'median reaction time during the second 15 minutes (minutes 16-30)' of the subtest 'vigilance', visual test condition 'moving bar', of the Test battery for Attention Performances (TAP) at end of treatment. (time frame: Baseline and End of Treatment). 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 24 May 2012.