Early Stage Parkinson's DiseasePhase 3NCT00335374
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
A Phase 3 study testing Pardoprunox in people with Early Stage Parkinson's Disease, run by Solvay Pharmaceuticals at 75 sites in 15 countries.
Trial summary
This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.003 trial Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Early Stage Parkinson's Disease
- What is being tested?
- Pardoprunox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 75 sitesin 15 countries
- Study dates
- Aug 2007to Nov 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
- Patients who have completed S308.3.003 trial
Who cannot join
- Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.003
Trial locations and contacts
75 sites in 15 countries.
75 sites in 15 countries
United States14 sites
421
Augusta, Georgia
419
Birmingham, Alabama
403
Boca Raton, Florida
405
Boston, Massachusetts
420
Boston, Massachusetts
Site 402
Dayton, Ohio
410
Fort Wayne, Indiana
417
Lexington, Kentucky
406
Minneapolis, Minnesota
422
New Haven, Connecticut
413
Oceanside, California
408
Oxnard, California
412
Raleigh, North Carolina
411
Sarasota, Florida
Poland7 sites
373
Gdansk
371
Kalisz
369
Katowice
365
Krakow
368
Leszno
366
Lublin
370
Mosina
Czechia6 sites
315
Kralove
313
Olomouc
310
Ostrava
314
Ostrava
312
Pardubice
311
Pilsen
Germany6 sites
332
Bochum
331
Göttingen
329
Heidelberg
330
Leipzig
328
Lübeck
326
Wiesbaden
Australia5 sites
303
Bedford Park
304
Cheltenham
301
Concord
Site 300
East Gosford
302
Westmead
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
Kwei-Shan
385
Taipei
Netherlands4 sites
361
's-Hertogenbosch
364
Eindhoven
360
Groningen
362
Groningen
About this study
This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.003 trial
- Conditions
- Early Stage Parkinson's Disease
- Being tested
- Pardoprunox
- 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
12 -42 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pardoprunox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: laboratory data, adverse events, vital signs, ECG
Measured: 24 weeks
Secondary outcomes (1)
UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline
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 startAug 2007
- Primary completionSep 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
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
- NCT00335374
- Sponsor's protocol ID
- S308.3.008
- Other IDs
- 2006-000859-18
- Status last verified
- Feb 2009
- First submitted
- 8 Jun 2006
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
- ClinicalTrials.gov ID
- NCT00335374
- Acronym / sponsor ID
- S308.3.008
- Conditions
- Early Stage Parkinson's Disease
- Keywords
- Parkinson's disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 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, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.003 trial
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pardoprunox |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have completed S308.3.003 trial
Key exclusion criteria (1 listed)
- Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.003
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 |
|---|---|---|
| Pardoprunox12 -42 mg | Drug | 1 |
Primary outcome
Safety: laboratory data, adverse events, vital signs, ECG
Time frame: 24 weeks
1 secondary outcome
UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline
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 6 Feb 2009.
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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
75 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pardoprunox in people with Early Stage Parkinson's Disease, run by Solvay Pharmaceuticals at 75 sites in 15 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 1 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 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Poland, Czechia, Germany, Australia and 10 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. 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?
Safety: laboratory data, adverse events, vital signs, ECG (time frame: 24 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 6 Feb 2009.