Advanced Stage Parkinson's DiseasePhase 3NCT00407095

An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

A Phase 3 study testing Pardoprunox in people with Advanced Stage Parkinson's Disease, run by Solvay Pharmaceuticals at 87 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study. 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?: Pardoprunox
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 87 sitesin 13 countries
Study dates: Aug 2007to May 2009
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

Inclusion Criteria Patients who have completed S308.3.002 trial Exclusion Criteria Patients with medically relevant abnormal findings (ECG, physical examination, Aes) at end of the maintenance phase (visit M6, week 24) of study S308.3.002

Trial locations and contacts

87 sites in 13 countries.

Country

City, postcode or hospital

87 sites in 13 countries

United States14 sites

S308.3.007 Site # 219
Augusta, Georgia
S308.3.007 Site # 221
Chicago, Illinois
S308.3.007 Site # 222
Durham, North Carolina
S308.3.007 Site # 212
East Lansing, Michigan
S308.3.007 Site # 214
Fort Lauderdale, Florida
S308.3.007 Site # 218
Gainsville, Florida
S308.3.007 Site # 215
Houston, Texas
S308.3.007 Site # 216
Kansas City, Kansas
S308.3.007 Site # 220
La Jolla, California
S308.3.007 Site # 224
Lexington, Kentucky
S308.3.007 Site # 211
San Francisco, California
S308.3.007 Site # 217
St Louis, Missouri
S308.3.007 Site # 213
Tampa, Florida
S308.3.007 Site # 210
Tledo, Ohio

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Brazil11 sites

S308.3.007 Site # 114
Alto da Glória
S308.3.007 Site # 113
Belo Horizonte
S308.3.007 Site # 112
Campinas
S308.3.007 Site # 116
Marília
S308.3.007 Site # 111
Porto Alegre
S308.3.007 Site # 118
Porto Alegre
S308.3.007 Site # 117
Ribeirão Preto
S308.3.007 Site # 119
Salvador
S308.3.007 Site # 115
Sâo Paulo
S308.3.007 Site # 110
São Paulo
S308.3.007 Site # 125
São Paulo

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Argentina10 sites

S308.3.007 Site # 100
Buenos Aires
S308.3.007 Site # 101
Buenos Aires
S308.3.007 Site # 102
Buenos Aires
S308.3.007 Site # 103
Buenos Aires
S308.3.007 Site # 106
Buenos Aires
S308.3.007 Site # 107
Buenos Aires
S308.3.007 Site # 109
Buenos Aires
S308.3.007 Site # 105
Córdoba
S308.3.007 Site # 104
Mar del Plata
S308.3.007 Site # 108
Santa Fe

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Canada10 sites

S308.3.007 Site # 136
Calgary
S308.3.007 Site # 137
Greenfield Park
S308.3.007 Site # 133
Halifax
S308.3.007 Site # 132
Markham
S308.3.007 Site # 130
Montreal
S308.3.007 Site # 134
Ottawa
S308.3.007 Site # 138
Peterborough
S308.3.007 Site # 135
Sainte-Anne
S308.3.007 Site # 139
Toronto
S308.3.007 Site # 131
Windsor

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Russia9 sites

S308.3.007 Site # 193
Kazan'
S308.3.007 Site # 190
Moscow
S308.3.007 Site # 194
Moscow
S308.3.007 Site # 197
Moscow
S308.3.007 Site # 191
Saint Petersburg
S308.3.007 Site # 192
Saint Petersburg
S308.3.007 Site # 195
Saint Petersburg
S308.3.007 Site # 198
Saint Petersburg
S308.3.007 Site # 196
Yaroslavl

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Ukraine9 sites

S308.3.007 Site # 204
Dnipro
S308.3.007 Site # 206
Kharkiv
S308.3.007 Site # 201
Kyiv
S308.3.007 Site # 202
Kyiv
S308.3.007 Site # 205
Lviv
S308.3.007 Site # 203
Poltava
S308.3.007 Site # 208
Simferopol
S308.3.007 Site # 200
Vinnytsia
S308.3.007 Site # 207
Zaporozhya

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Bulgaria5 sites

S308.3.007 Site # 123
Plovdiv
S308.3.007 Site # 120
Sofia
S308.3.007 Site # 121
Sofia
S308.3.007 Site # 122
Sofia
S308.3.007 Site # 124
Sofia

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Colombia5 sites

S308.3.007 Site # 151
Bogotá
S308.3.007 Site # 152
Bogotá
S308.3.007 Site # 153
Bogotá
S308.3.007 Site # 154
Bogotá
S308.3.007 Site # 150
Medellín

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Peru5 sites

S308.3.007 Site # 184
Bellavista Callao
S308.3.007 Site # 180
Lima
S308.3.007 Site # 181
Lima
S308.3.007 Site # 182
Lima
S308.3.007 Site # 183
Lima

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Chile4 sites

S308.3.007 Site # 140
Santiago
S308.3.007 Site # 141
Santiago
S308.3.007 Site # 143
Santiago
S308.3.007 Site # 142
Valdivia

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Lithuania3 sites

S308.3.007 Site # 172
Kaunas
S308.3.007 Site # 170
Vilnius
S308.3.007 Site # 171
Vilnius

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Albania1 site

S308.3.007 Site # 223
Birmingham

Other trials in Albania

Latvia1 site

S308.3.007 Site # 160
Riga

Other trials in Latvia

About this study

This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.

Conditions: Advanced Stage Parkinson's Disease
Being tested: Pardoprunox
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.

PardoprunoxDrug
12-42 mg/day

Study groups in NCT00407095
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: 36 weeks

Secondary outcomes (1)

On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline
Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007May 2009

First posted4 Dec 2006 (estimated)
Study startAug 2007
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00407095
Sponsor's protocol ID: S308.3.007
Other IDs: 2006-005183-91, 00407095
Status last verified: Sep 2010
First submitted: 30 Nov 2006
Last updated: 13 Sep 2010
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase 1 Study of NCR201 in Parkinson's Disease Patients With Prior DBS
PARKINSON DISEASE (Disorder), Cell Therapy
RecruitingObservational study
Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)
Parkinson's Disease
RecruitingPhase 1/2
This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary Efficacy of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in Patients With Parkinson's Disease.
Parkinson Disease
Not yet recruitingPhase 1
Phase I Clinical Study of NouvNeu001 Injection for the Treatment of Moderate-to-Advanced Parkinson's Disease in Patients Who Have Previously Undergone Deep Brain Stimulation or Deep Brain Nucleus Lesioning Surgery
Parkinson's Disease (PD)
RecruitingEarly Phase 1
Evaluation of GM101 Injection in Patients With Parkinson's Disease
Parkinson's Disease

All Advanced Stage Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
ClinicalTrials.gov ID: NCT00407095
Acronym / sponsor ID: S308.3.007
Conditions: Advanced Stage Parkinson's Disease
Keywords: Parkinson Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (estimated)
Lead sponsor: Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: May 2009 (actual)
Study completion: May 2009 (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, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.

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

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/day	Drug	1

Primary outcome

Safety: laboratory data, adverse events, vital signs, ECG
Time frame: 36 weeks

1 secondary outcome

On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline
Time frame: 36 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 13 Sep 2010.

Related trials for Advanced Stage Parkinson's Disease

Not yet recruitingPhase 1
A Phase 1 Study of NCR201 in Parkinson's Disease Patients With Prior DBS
PARKINSON DISEASE (Disorder), Cell Therapy
RecruitingObservational study
Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)
Parkinson's Disease
RecruitingPhase 1/2
This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary Efficacy of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in Patients With Parkinson's Disease.
Parkinson Disease
Not yet recruitingPhase 1
Phase I Clinical Study of NouvNeu001 Injection for the Treatment of Moderate-to-Advanced Parkinson's Disease in Patients Who Have Previously Undergone Deep Brain Stimulation or Deep Brain Nucleus Lesioning Surgery
Parkinson's Disease (PD)
RecruitingEarly Phase 1
Evaluation of GM101 Injection in Patients With Parkinson's Disease
Parkinson's Disease

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.

Erik Vanleeuwen study director

Abbott Products

87 sites in 13 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 Advanced Stage Parkinson's Disease, run by Solvay Pharmaceuticals at 87 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 13 Sep 2010. 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 8 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: 36 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 NCT00407095.

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 13 Sep 2010.