Advanced Stage Parkinson's DiseasePhase 2NCT00903838
A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.
A Phase 2 study testing pardoprunox and pramipexole in people with Advanced Stage Parkinson's Disease, run by Abbott Products at 9 sites in 3 countries.
Trial summary
This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Advanced Stage Parkinson's Disease
- What is being tested?
- pardoprunox and pramipexole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Sep 2009to May 2011
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have signed informed consent
- Diagnosis of idiopathic Parkinson's Disease
- Stable treatment with L-dopa and dopamine agonist for at least 28 days prior to randomization
- Presence of a recognizable ON and OFF state (motor fluctuations)
- Minimum hours of OFF-time per day of 1.5 hours (during waking hours including early morning akinesia) as recorded per baseline diaries
- Minimum hours of ON time with troublesome dyskinesia of 2 hours (during waking hours) as recorded per baseline diaries
- Prevalent expression of severely disabling dyskinesias during the waking day, i.e. dyskinesias are present at least 25% of the waking hours (UPDRS Part 4 item 32 >= 2) in combination with a degree of disability which is moderate or higher (UPDRS Part 4 item 33 >=2)
Who cannot join
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes
- Patients who have undergone surgery for the treatment of PD
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Germany4 sites
Site Reference ID/Investigator# 45433
Göttingen, 37075
Site Reference ID/Investigator# 45428
Kassel, 34128
Site Reference ID/Investigator# 45422
Tübingen, BW 72076
Site Reference ID/Investigator# 45427
Ulm, 89081
Italy3 sites
Site Reference ID/Investigator# 45435
Cassino, 03043
Site Reference ID/Investigator# 45436
Chieti Scalo, 66013
Site Reference ID/Investigator# 45437
Rome, 00163
Portugal2 sites
Site Reference ID/Investigator# 45438
Coimbra, 3000-075
Site Reference ID/Investigator# 45439
Lisbon, 1649-035
About this study
Official title: A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.
This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa.
Read the detailed description
Approximately 44 patients are to be randomized in a 3:1 ratio to two possible treatment groups, pardoprunox and pramipexole, respectively. The first part of the study will be blinded and consists of a minimum 1-week screening period, a 4-week switch and stabilization period and an 8-week maintenance period. The second part of the study will be open label pardoprunox treatment with a dose adjustment period of 4 weeks followed by long term maintenance treatment.
- Conditions
- Advanced Stage Parkinson's Disease
- Being tested
- pardoprunox, pramipexole
- Keywords
- Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pardoprunoxDrug
1.5 to 12 mg/day
pramipexoleDrug
0.75-4.5 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: pardoprunox |
| 2 | Active comparator | Not described Receives: Drug: pramipexole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint in ON-time without dyskinesia
Measured: 16 weeks
Secondary outcomes (1)
Change from baseline in ON-time with (troublesome) dyskinesia; OFF-time; UDysRS, UPDRS (part II + III during ON and OFF state) and Part 4
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: The study was terminated on 31 May, 2011, due to strategic considerations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Stage 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juliana Bronzova, MD, Study director, Abbott Healthcare Products B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903838
- Sponsor's protocol ID
- S308.2.008
- Other IDs
- 2008-000400-81, 2008
- Status last verified
- Aug 2011
- First submitted
- 14 May 2009
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.
- ClinicalTrials.gov ID
- NCT00903838
- Acronym / sponsor ID
- S308.2.008
- Conditions
- Advanced Stage Parkinson's Disease
- Keywords
- Parkinson's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated on 31 May, 2011, due to strategic considerations.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Abbott ProductsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 May 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.
This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa.
Detailed description
Approximately 44 patients are to be randomized in a 3:1 ratio to two possible treatment groups, pardoprunox and pramipexole, respectively. The first part of the study will be blinded and consists of a minimum 1-week screening period, a 4-week switch and stabilization period and an 8-week maintenance period. The second part of the study will be open label pardoprunox treatment with a dose adjustment period of 4 weeks followed by long term maintenance treatment.
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 |
|---|---|---|
| 1 | Experimental | Drug: pardoprunox |
| 2 | Active comparator | Drug: pramipexole |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have signed informed consent
- Diagnosis of idiopathic Parkinson's Disease
- Stable treatment with L-dopa and dopamine agonist for at least 28 days prior to randomization
- Presence of a recognizable ON and OFF state (motor fluctuations)
- Minimum hours of OFF-time per day of 1.5 hours (during waking hours including early morning akinesia) as recorded per baseline diaries
Key exclusion criteria (2 listed)
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes
- Patients who have undergone surgery for the treatment of PD
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 |
|---|---|---|
| pardoprunox1.5 to 12 mg/day | Drug | 1 |
| pramipexole0.75-4.5 mg/day | Drug | 2 |
Primary outcome
Change from baseline to endpoint in ON-time without dyskinesia
Time frame: 16 weeks
1 secondary outcome
Change from baseline in ON-time with (troublesome) dyskinesia; OFF-time; UDysRS, UPDRS (part II + III during ON and OFF state) and Part 4
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: The study was terminated on 31 May, 2011, due to strategic considerations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
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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.
Juliana Bronzova, MD study director
Abbott Healthcare Products B.V.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pardoprunox and pramipexole in people with Advanced Stage Parkinson's Disease, run by Abbott Products at 9 sites in 3 countries.
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 2 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 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Italy, Portugal. 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 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: The study was terminated on 31 May, 2011, due to strategic considerations.). 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?
Change from baseline to endpoint in ON-time without dyskinesia (time frame: 16 weeks). 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 26 Aug 2011.