Early Stage Parkinson's DiseasePhase 3NCT00269516
SLV308 for Treatment of Patients With Early Parkinson's Disease
A Phase 3 study testing pardoprunox in people with Early Stage Parkinson's Disease, run by Solvay Pharmaceuticals at 128 sites in 21 countries.
Trial summary
This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a 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's Disease
- What is being tested?
- pardoprunox
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 128 sitesin 21 countries
- Study dates
- Jun 2006to Dec 2007
- 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,
- Early stage of disease, Modified Hoehn \& Yahr up to stage III,
- UPDRS motor score (part III) 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,
- Presence of dyskinesias,
- Motor fluctuations or loss of postural reflexes,
- Clinically significant abnormalities,
- Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
- Antipsychotic.
Trial locations and contacts
128 sites in 21 countries.
128 sites in 21 countries
United States24 sites
Site 288
Ashville, North Carolina
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
Argentina8 sites
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
Vinnytsia
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
Official title: A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease
This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a 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's Disease
- Being tested
- pardoprunox, Placebo
- 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
fixed dose 6 mg
PardoprunoxDrug
fixed dose 12 mg
PardoprunoxDrug
12-42mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: pardoprunox |
| 2 | Experimental | Not described Receives: Drug: Pardoprunox |
| 3 | Experimental | Not described Receives: Drug: Pardoprunox |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
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: 6 months
Secondary outcomes (1)
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startJun 2006
- Primary completionDec 2007
- Study completionDec 2007
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'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
- 468 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
- NCT00269516
- Sponsor's protocol ID
- S308.3.001
- Status last verified
- Aug 2008
- First submitted
- 22 Dec 2005
- Last updated
- 29 Aug 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 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00269516
- Acronym / sponsor ID
- S308.3.001
- Conditions
- Early Stage Parkinson's Disease
- Keywords
- Parkinson's disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Dec 2005 (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 6 months' treatment with SLV308 administered as a 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
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: pardoprunox |
| 2 | Experimental | Drug: Pardoprunox |
| 3 | Experimental | Drug: Pardoprunox |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic Parkinson's Disease,
- Early stage of disease, Modified Hoehn \& Yahr up to stage III,
- UPDRS motor score (part III) 10 at baseline.
Key exclusion criteria (7 listed)
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
- Patients who have undergone surgery for the treatment of PD,
- Presence of dyskinesias,
- Motor fluctuations or loss of postural reflexes,
- Clinically significant abnormalities,
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 |
|---|---|---|
| pardoprunoxfixed dose 6 mg | Drug | 1 |
| Pardoprunoxfixed dose 12 mg | Drug | 2 |
| Pardoprunox12-42mg | Drug | 3 |
| PlaceboPlacebo | Drug | 4 |
Primary outcome
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
Time frame: 6 months
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: 6 months
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 29 Aug 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
128 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 128 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 3 inclusion and 7 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 29 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 128 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. 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: 6 months). 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 NCT00269516, 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 29 Aug 2008.