Early Stage Parkinson's DiseasePhase 3NCT00332917
An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
A Phase 3 study testing Pardoprunox in people with Early Stage Parkinson's Disease, run by Solvay Pharmaceuticals at 130 sites in 21 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 S308.3.001 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
- 224 participants
- Where
- 130 sitesin 21 countries
- Study dates
- Feb 2007to Jul 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 S308.3.001 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 S308.3.001
Trial locations and contacts
130 sites in 21 countries.
130 sites in 21 countries
United States25 sites
Site 288
Ashville, North Carolina
Site 270
Bennington, Vermont
Site 292
Bingham Farms, Michigan
Site 289
Charlotte, North Carolina
Site 290
Chicago, Illinois
Site 279
Fort Lauderdale, Florida
Site 283
Fountain Valley, California
Site 293
Gainsville, Florida
Site 272
Houston, Texas
Site 284
Huntsville, Alabama
Site 280
Kansas City, Kansas
Site 277
La Jolla, California
Site 278
Las Vegas, Nevada
Site 274
Little Rock, Arkansas
Site 281
Pittsburgh, Pennsylvania
Site 282
Port Charlotte, Florida
Site 286
Rochester, New York
Site 271
San Francisco, California
Site 276
St Louis, Missouri
Site 287
St Louis, Missouri
Site 285
Sunrise, Florida
Site 273
Tampa, Florida
Site 294
Toledo, Ohio
Site 275
Traverse City, Michigan
Site 291
Warwick, Rhode Island
Canada10 sites
Site 268
Barrie
Site 260
Calgary
Site 264
Greenfield Park
Site 263
Markham
Site 261
Ottawa
Site 266
Ottawa
Site 262
Québec
Site 265
Québec
Site 269
Saskatoon
Site 267
Toronto
Russia10 sites
Site 158
Kazan'
Site 150
Moscow
Site 151
Moscow
Site 154
Moscow
Site 156
Moscow
Site 152
Saint Petersburg
Site 157
Saint Petersburg
Site 159
Saint Petersburg
Site 155
Smolensk
Site 153
Yaroslav
Argentina9 sites
Site 200
Buenos Aires
Site 201
Buenos Aires
Site 202
Buenos Aires
Site 203
Buenos Aires
Site 204
Buenos Aires
Site 206
Buenos Aires
Site 208
Capital Federal, CBA
Site 207
Ciudad de Buenos Aires
Site 205
Córdoba
India7 sites
Site 196
Bangalore
Site 194
Hyderabaad
Site 193
Mumbai
Site 195
Mumbai
Site 199
New Delhi
Site 198
Thiruvananthapuram
Site 197
Visakhapatnam
Ukraine6 sites
Site 180
Kharkiv
Site 183
Kharkiv
Site 181
Kyiv
Site 182
Kyiv
Site 185
Lviv
Site 184
Vinnitsa
Bulgaria5 sites
Site 107
Plovdiv
Site 103
Sofia
Site 104
Sofia
Site 105
Sofia
Site 106
Sofia
Colombia5 sites
Site 221
Bogotá
Site 223
Bogotá
Site 224
Bogotá
Site 222
Cali
Site 220
Medellín
Croatia5 sites
Site 111
Rijeka
Site 112
Split
Site 110
Zagreb
Site 113
Zagreb
Site 114
Zagreb
Finland5 sites
Site 123
Kuopio
Site 122
Lappeenranta
Site 120
Oulun Yliopisto
Site 121
Tampere
Site 124
Turku
Peru5 sites
Site 244
Barrios Altos-Lima
Site 241
La Victoria-Lima
Site 240
Lima
Site 243
San Isidro-Lima
Site 242
Surco-Lima
Slovakia5 sites
Site 170
Bratislava
Site 171
Bratislava
Site 174
Levice
Site 173
Nitra
Site 172
Žilina
South Africa5 sites
Site 250
Cape Town
Site 252
Cape Town
Site 251
Durban
Site 253
Gauteng
Site 254
Pretoria
Chile4 sites
Site 213
Providencia
Site 211
San Miguel
Site 210
Santiago
Site 212
Valdivia
Israel4 sites
Site 131
Haifa
Site 132
Petah Tikva
Site 133
Ramat Gan
Site 130
Tel Aviv
Mexico4 sites
Site 232
Aguascalientes
Site 230
Guadalajara - Jalisco
Site 231
Monterrey N.L.
Site 233
Tlalpan
Romania4 sites
Site 143
Brasov
Site 140
Bucharest
Site 141
Craiova
Site 142
Mures
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 S308.3.001 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 posted2 Jun 2006 (estimated)
- Study startFeb 2007
- Primary completionJul 2008
- Study completionJul 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
- 224 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
- NCT00332917
- Sponsor's protocol ID
- S308.3.006
- Other IDs
- 2006-000858-45
- Status last verified
- Jan 2009
- First submitted
- 1 Jun 2006
- Last updated
- 26 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
- ClinicalTrials.gov ID
- NCT00332917
- Acronym / sponsor ID
- S308.3.006
- Conditions
- Early Stage Parkinson's Disease
- Keywords
- Parkinson's disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 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 S308.3.001 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 S308.3.001 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 S308.3.001
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 26 Jan 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
130 sites in 21 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 130 sites in 21 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 26 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 130 sites in United States, Canada, Russia, Argentina, India and 16 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 26 Jan 2009.