SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease

Early Stage Parkinson Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335166
• Other study ID #: S308.3.003
• Secondary ID: Not requested ye
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2006
• Last updated: April 1, 2008
• Start date: November 2006
• Est. completion date: February 2008

Study information

• Verified date: April 2008
• 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, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of idiopathic Parkinson's Disease, Modified Hoehn & Yahr up to stage III, UPDRS motor score (part III) must have a total of at least 10 at baseline.

Exclusion Criteria:

• Diagnosis is unclear or a suspicion of other parkinsonian syndromes,

• Patients who have undergone surgery for the treatment of PD,

• Current presence of dyskinesias,

• Motor fluctuations or loss of postural reflexes,

• A history of non-response to an adequate course of l-dopa or a dopamine agonist,

• Patients for whom previously treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and /or sleep attacks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Early Stage Parkinson Disease
• Parkinson Disease

Intervention

Drug:
• Pardaprunox
12-42 mg
• pramipexole
1.5-4.5 mg
• Placebo Comparator
Placebo

Locations

Country	Name	City	State
Australia	303	Bedford Park
Australia	304	Cheltenham
Australia	301	Concord
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
France	323	Aix en Provence
France	324	Toulon
France	325	Toulouse
Germany	332	Bochum
Germany	331	Gottingen
Germany	329	Heidelberg
Germany	327	Homburg
Germany	330	Leipzig
Germany	328	Lubeck
Germany	326	Wiesbaden
India	338	Bangalore
India	339	Hyderabad
India	337	Kerala
India	336	Mumbai
India	340	Mumbai
Italy	347	Arcugnano (VI)
Italy	348	Grosseto GR
Italy	346	Lido di Camaiore (LU)
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	363	Emmen
Netherlands	362	Groningen
Netherlands	361	Hertogenbosch
Netherlands	360	RM Groningen
Poland	373	Gdansk
Poland	371	Kalisz
Poland	369	Katowice
Poland	374	Katowice
Poland	365	Krakow
Poland	368	Leszno
Poland	366	Lublin
Poland	370	Mosina
Poland	367	Torun
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
Spain	383	Barcelona
Spain	384	Colmenar Viejo
Spain	382	San Sebastian
Taiwan	388	Hualien
Taiwan	387	Kaohsiung
Taiwan	389	Kaohsiung Hsien
Taiwan	386	Kweishan
Taiwan	385	Taipei
Thailand	391	Bangkok
Thailand	393	Bangkok
Thailand	394	Ubonratchathani Province
United Kingdom	396	Blackpool
United States	418	Albany	New York
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	424	Charlotte	North Carolina
United States	410	Ft Wayne	Indiana
United States	416	Golden Valley	Minnesota
United States	415	Grand Rapids	Michigan
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,  France,  Germany,  India,  Italy,  Lithuania,  Malaysia,  Netherlands,  Poland,  Portugal,  South Africa,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment		24 weeks	No
Secondary	UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.		24 weeks	No