Early Stage Parkinson DiseasePhase 3NCT00335166
SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
A Phase 3 study testing Pardaprunox and pramipexole in people with Early Stage Parkinson Disease, run by Solvay Pharmaceuticals at 89 sites in 18 countries.
Trial summary
This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early 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
- Early Stage Parkinson Disease
- What is being tested?
- Pardaprunox and pramipexole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 89 sitesin 18 countries
- Study dates
- Nov 2006to Feb 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, Modified Hoehn \& Yahr up to stage III, UPDRS motor score (part III) must have a total of at least 10 at baseline.
Who cannot join
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
- Patients who have undergone surgery for the treatment of PD,
- Current presence of dyskinesias,
- Motor fluctuations or loss of postural reflexes,
- A history of non-response to an adequate course of l-dopa or a dopamine agonist,
- Patients for whom previously treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and /or sleep attacks.
Trial locations and contacts
89 sites in 18 countries.
89 sites in 18 countries
United States17 sites
418
Albany, New York
421
Augusta, Georgia
419
Birmingham, Alabama
403
Boca Raton, Florida
405
Boston, Massachusetts
420
Boston, Massachusetts
424
Charlotte, North Carolina
410
Fort Wayne, Indiana
416
Golden Valley, Minnesota
415
Grand Rapids, Michigan
417
Lexington, Kentucky
406
Minneapolis, Minnesota
422
New Haven, Connecticut
413
Oceanside, California
408
Oxnard, California
412
Raleigh, North Carolina
411
Sarasota, Florida
Poland9 sites
373
Gdansk
371
Kalisz
369
Katowice
374
Katowice
365
Krakow
368
Leszno
366
Lublin
370
Mosina
367
Torun
Germany7 sites
332
Bochum
331
Göttingen
329
Heidelberg
327
Homburg
330
Leipzig
328
Lübeck
326
Wiesbaden
Czechia6 sites
315
Kralove
313
Olomouc
310
Ostrava
314
Ostrava
312
Pardubice
311
Pilsen
Italy6 sites
347
Arcugnano (VI)
348
Grosseto GR
346
Lido Di Camaiore (LU)
344
Pescara
343
Roma
345
Roma
Netherlands5 sites
361
's-Hertogenbosch
364
Eindhoven
363
Emmen
362
Groningen
360
RM Groningen
South Africa5 sites
377
Cape Town
378
Cape Town
380
Gauteng
381
Pretoria
379
Sandton
Taiwan5 sites
388
Hualien City
387
Kaohsiung City
389
Kaohsiung Hsien
386
Kweishan
385
Taipei
About this study
Official title: A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.
This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early 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
- Early Stage Parkinson Disease
- Being tested
- Pardaprunox, pramipexole, 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.
PardaprunoxDrug
12-42 mg
pramipexoleDrug
1.5-4.5 mg
Placebo ComparatorDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pardaprunox |
| 2 | Active comparator | Not described Receives: Drug: pramipexole |
| 3 | 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.
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
Measured: 24 weeks
Secondary outcomes (1)
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startNov 2006
- Primary completionFeb 2008
- Study completionFeb 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 Early Stage Parkinson 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
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335166
- Sponsor's protocol ID
- S308.3.003
- Other IDs
- Not requested yet
- Status last verified
- Apr 2008
- First submitted
- 8 Jun 2006
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3.
PubMed 21542016
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT00335166
- Acronym / sponsor ID
- S308.3.003
- Conditions
- Early Stage Parkinson Disease
- Keywords
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 9 Jun 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 is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pardaprunox |
| 2 | Active comparator | Drug: pramipexole |
| 3 | 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 (1 listed)
- Diagnosis of idiopathic Parkinson's Disease, Modified Hoehn \& Yahr up to stage III, UPDRS motor score (part III) must have a total of at least 10 at baseline.
Key exclusion criteria (6 listed)
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
- Patients who have undergone surgery for the treatment of PD,
- Current presence of dyskinesias,
- Motor fluctuations or loss of postural reflexes,
- A history of non-response to an adequate course of l-dopa or a dopamine agonist,
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 |
|---|---|---|
| Pardaprunox12-42 mg | Drug | 1 |
| pramipexole1.5-4.5 mg | Drug | 2 |
| Placebo ComparatorPlacebo | Drug | 3 |
Primary outcome
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
Time frame: 24 weeks
1 secondary outcome
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.
Time frame: 24 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 3 Apr 2008.
- Derived from this study: PubMed 21542016Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3.
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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
89 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pardaprunox and pramipexole in people with Early Stage Parkinson Disease, run by Solvay Pharmaceuticals at 89 sites in 18 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 1 inclusion and 6 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 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Poland, Germany, Czechia, Italy and 13 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?
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (time frame: 24 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 NCT00335166, 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 3 Apr 2008.