An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients

Early Stage Parkinson's Disease Clinical Trial

Official title:

An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335374
• Other study ID #: S308.3.008
• Secondary ID: 2006-000859-18
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2006
• Last updated: February 5, 2009
• Start date: August 2007
• Est. completion date: November 2008

Study information

• Verified date: February 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutIndia: Ministry of HealthItaly: The Italian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesTaiwan: Department of HealthThailand: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyLithuania: State Medicine Control Agency - Ministry of HealthMalaysia: Ministry of Health
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Patients who have completed S308.3.003 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 S308.3.003

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Early Stage Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• Pardoprunox
12 -42 mg

Locations

Country	Name	City	State
Australia	303	Bedford Park
Australia	304	Cheltenham
Australia	301	Concord
Australia	Site 300	East Gosford
Australia	302	Westmead
Czech Republic	315	Kralove
Czech Republic	313	Olomouc
Czech Republic	310	Ostrava
Czech Republic	314	Ostrava
Czech Republic	312	Pardubice
Czech Republic	311	Plzen
Estonia	320	Tallinn
Estonia	321	Tartu
Germany	332	Bochum
Germany	331	Gottingen
Germany	329	Heidelberg
Germany	330	Leipzig
Germany	328	Lubeck
Germany	326	Wiesbaden
India	338	Bangalore
India	339	Hyderabaad
India	337	Kerala
India	336	Mumbai
India	340	Mumbai
Italy	348	Grosseto
Italy	346	Lido di Camaiore
Italy	344	Pescara
Italy	343	Roma
Italy	345	Roma
Lithuania	428	Kaunas
Lithuania	427	Vilnius
Lithuania	429	Vilnius
Malaysia	355	Kelantan
Malaysia	357	Kuala Lumpur
Malaysia	356	Pulau Pinang
Netherlands	364	Eindhoven
Netherlands	360	Groningen
Netherlands	362	Groningen
Netherlands	361	Hertogenbosch
Poland	373	Gdansk
Poland	371	Kalisz
Poland	369	Katowice
Poland	365	Krakow
Poland	368	Leszno
Poland	366	Lublin
Poland	370	Mosina
Portugal	376	Coimbra
Portugal	375	Lisboa
South Africa	377	Cape Town
South Africa	378	Cape Town
South Africa	380	Gauteng
South Africa	381	Pretoria
South Africa	379	Sandton
Taiwan	388	Hualien
Taiwan	387	Kaohsiung
Taiwan	389	Kaohsiung Hsien
Taiwan	386	Kwei-Shan
Taiwan	385	Taipei
Thailand	391	Bangkok
Thailand	393	Bangkok
Thailand	394	Ubonratchathani
United States	421	Augusta	Georgia
United States	419	Birmingham	Alabama
United States	403	Boca Raton	Florida
United States	405	Boston	Massachusetts
United States	420	Boston	Massachusetts
United States	Site 402	Dayton	Ohio
United States	410	Ft Wayne	Indiana
United States	417	Lexington	Kentucky
United States	406	Minneapolis	Minnesota
United States	422	New Haven	Connecticut
United States	413	Oceanside	California
United States	408	Oxnard	California
United States	412	Raleigh	North Carolina
United States	411	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Czech Republic,  Estonia,  Germany,  India,  Italy,  Lithuania,  Malaysia,  Netherlands,  Poland,  Portugal,  South Africa,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: laboratory data, adverse events, vital signs, ECG		24 weeks	Yes
Secondary	UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline		24 weeks	No