Advanced Stage Parkinson's DiseasePhase 3NCT00406588
SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations
A Phase 3 study testing Levodopa (Pardoprunox) in people with Advanced Stage Parkinson's Disease, run by Solvay Pharmaceuticals at 87 sites in 12 countries.
Trial summary
This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate. 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?
- Levodopa (Pardoprunox)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 87 sitesin 12 countries
- Study dates
- Mar 2007to May 2008
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's Disease,
- advance stage of disease,
- Modified Hoehn \& Yahr stage II-IV,
- presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization
Who cannot join
- 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,
- Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,
- Previous surgery for the treatment of PD
Trial locations and contacts
87 sites in 12 countries.
87 sites in 12 countries
United States15 sites
Site 219
Augusta, Georgia
Site 223
Birmingham, Alabama
Site 221
Chicago, Illinois
Site 222
Durham, North Carolina
Site 212
East Lansing, Michigan
Site 214
Fort Lauderdale, Florida
Site 218
Gainsville, Florida
Site 215
Houston, Texas
Site 216
Kansas City, Kansas
Site 220
La Jolla, California
Site 224
Lexington, Kentucky
Site 211
San Francisco, California
Site 217
St Louis, Missouri
Site 213
Tampa, Florida
Site 210
Toledo, Ohio
Brazil11 sites
Site 114
Alto da Glória
Site 113
Belo Horizonte
Site 112
Campinas
Site 116
Marília
Site 111
Porto Alegre
Site 118
Porto Alegre
Site 117
Ribeirão Preto
Site 119
Salvador
Site 110
São Paulo
Site 115
São Paulo
Site 125
São Paulo
Argentina10 sites
Site 100
Buenos Aires
Site 101
Buenos Aires
Site 102
Buenos Aires
Site 103
Buenos Aires
Site 106
Buenos Aires
Site 107
Buenos Aires
Site 109
Buenos Aires
Site 105
Córdoba
Site 104
Mar del Plata
Site 108
Santa Fe
Canada10 sites
Site 136
Calgary
Site 137
Greenfield Park
Site 133
Halifax
Site 132
Markham
Site 130
Montreal
Site 134
Ottawa
Site 138
Peterborough
Site 135
Sainte-Anne
Site 139
Toronto
Site 131
Windsor
Russia9 sites
Site 193
Kazan'
Site 190
Moscow
Site 194
Moscow
Site 197
Moscow
Site 191
Saint Petersburg
Site 192
Saint Petersburg
Site 195
Saint Petersburg
Site 198
Saint Petersburg
Site 196
Yaroslavl
Ukraine9 sites
Site 204
Dnipro
Site 206
Kharkiv
Site 201
Kyiv
Site 202
Kyiv
Site 205
Lviv
Site 203
Poltava
Site 208
Simferopol
Site 200
Vinnitsa
Site 207
Zaporizhya
Bulgaria5 sites
Site 123
Plovdiv
Site 120
Sofia
Site 121
Sofia
Site 122
Sofia
Site 124
Sofia
Colombia5 sites
Site 151
Bogotá
Site 152
Bogotá
Site 153
Bogotá
Site 154
Bogotá
Site 150
Medellín
Peru5 sites
Site 184
Bellavista Callao
Site 180
Lima
Site 181
Lima
Site 182
Lima
Site 183
Lima
Chile4 sites
Site 140
Santiago
Site 141
Santiago
Site 143
Santiago
Site 142
Valdivia
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.
- Conditions
- Advanced Stage Parkinson's Disease
- Being tested
- Levodopa (Pardoprunox), Placebo Comparator
- Keywords
- Parkinson 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.
Levodopa (Pardoprunox)Drug
12-42mg
Placebo ComparatorDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Levodopa (Pardoprunox) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries.
Measured: 12 weeks
Secondary outcomes (1)
Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406588
- Sponsor's protocol ID
- S308.3.002
- Other IDs
- 2006-005182-20
- Status last verified
- Jul 2008
- First submitted
- 30 Nov 2006
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rascol O, Bronzova J, Hauser RA, Lang AE, Sampaio C, Theeuwes A, van de Witte SV. Pardoprunox as adjunct therapy to levodopa in patients with Parkinson's disease experiencing motor fluctuations: results of a double-blind, randomized, placebo-controlled, trial. Parkinsonism Relat Disord. 2012 May;18(4):370-6. doi: 10.1016/j.parkreldis.2011.12.006. Epub 2012 Feb 7.
PubMed 22316635
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
- ClinicalTrials.gov ID
- NCT00406588
- Acronym / sponsor ID
- S308.3.002
- Conditions
- Advanced Stage Parkinson's Disease
- Keywords
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 Dec 2006 (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 study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.
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: Levodopa (Pardoprunox) |
| 2 | Placebo comparator | Drug: Placebo Comparator |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic Parkinson's Disease,
- advance stage of disease,
- Modified Hoehn \& Yahr stage II-IV,
- presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization
Key exclusion criteria (4 listed)
- 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,
- Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,
- Previous 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 |
|---|---|---|
| Levodopa (Pardoprunox)12-42mg | Drug | 1 |
| Placebo ComparatorPlacebo | Drug | 2 |
Primary outcome
Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries.
Time frame: 12 weeks
1 secondary outcome
Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39
Time frame: 12 weeks
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 27 Feb 2015.
- Derived from this study: PubMed 22316635Rascol O, Bronzova J, Hauser RA, Lang AE, Sampaio C, Theeuwes A, van de Witte SV. Pardoprunox as adjunct therapy to levodopa in patients with Parkinson's disease experiencing motor fluctuations: results of a double-blind, randomized, placebo-controlled, trial. Parkinsonism Relat Disord. 2012 May;18(4):370-6. doi: 10.1016/j.parkreldis.2011.12.006. Epub 2012 Feb 7.
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
87 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levodopa (Pardoprunox) in people with Advanced Stage Parkinson's Disease, run by Solvay Pharmaceuticals at 87 sites in 12 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 4 inclusion and 4 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 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Brazil, Argentina, Canada, Russia and 7 more countries. 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 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?
Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00406588, which also lists 1 linked publication.
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 27 Feb 2015.