SLV308 for Treatment of Patients With Early Parkinson's Disease

Early Stage Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269516
• Other study ID #: S308.3.001
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: August 28, 2008
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: August 2008
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPFinland: Finnish Medicines AgencyRomania: National Medicines AgencySlovakia: State Institute for Drug ControlSweden: Medical Products AgencyBulgaria: Bulgarian Drug AgencyCroatia: Ministry of Health and Social CareRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesUkraine: Ministry of HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChile: Instituto de Salud Pública de ChilePeru: Ministry of HealthMexico: Federal Commission for Protection Against Health RisksSouth Africa: Medicines Control CouncilIndia: Ministry of HealthCanada: Canadian Institutes of Health ResearchNew Zealand: MedsafeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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's Disease
• Parkinson Disease

Intervention

Drug:
• pardoprunox
fixed dose 6 mg
• Pardoprunox
fixed dose 12 mg
• Pardoprunox
12-42mg
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Site 201	Buenos Aires
Argentina	Site 202	Buenos Aires
Argentina	Site 204	Buenos Aires
Argentina	Site 206	Buenos Aires
Argentina	Site 208	Capital Federal, CBA
Argentina	Site 203	Ciudad Autonoma de Buenos Aires
Argentina	Site 207	Ciudad de Buenos Aires
Argentina	Site 205	Cordoba
Belgium	Site 100	Brussels
Belgium	Site 101	Genk
Belgium	Site 102	Wilrijk
Bulgaria	Site 107	Plovdiv
Bulgaria	Site 103	Sofia
Bulgaria	Site 104	Sofia
Bulgaria	Site 105	Sofia
Bulgaria	Site 106	Sofia
Canada	Site 268	Barrie
Canada	Site 260	Calgary
Canada	Site 264	Greenfield Park
Canada	Site 263	Markham
Canada	Site 261	Ottawa
Canada	Site 266	Ottawa
Canada	Site 262	Quebec
Canada	Site 265	Quebec
Canada	Site 269	Saskatoon
Canada	Site 267	Toronto
Chile	Site 213	Providencia
Chile	Site 211	San Miguel
Chile	Site 210	Santiago de Chile
Chile	Site 212	Valdivia
Colombia	Site 221	Bogota
Colombia	Site 223	Bogota
Colombia	Site 224	Bogota
Colombia	Site 222	Cali
Colombia	Site 220	Medellin
Croatia	Site 111	Rijeka
Croatia	Site 112	Split
Croatia	Site 110	Zagreb
Croatia	Site 113	Zagreb
Croatia	Site 114	Zagreb
Finland	Site 123	Kuopio
Finland	Site 122	Lappeenranta
Finland	Site 120	Oulun yliopisto
Finland	Site 121	Tampere
Finland	Site 124	Turku
India	Site 196	Bangalore
India	Site 194	Hyderabaad
India	Site 193	Mumbai
India	Site 195	Mumbai
India	Site 199	New Delhi
India	Site 198	Thiruvananthapuram
India	Site 197	Visakhapatnam
Israel	Site 131	Haifa
Israel	Site 132	Petach-Tikva
Israel	Site 133	Ramat-Gan
Israel	Site 130	Tel Aviv
Mexico	Site 232	Aguascalientes
Mexico	Site 230	Guadalajara - Jalisco
Mexico	Site 231	Monterrey N.L.
Mexico	Site 233	Tlalpan
New Zealand	Site 191	Christchurch
New Zealand	Site 190	Wellington South
Peru	Site 244	Barrios Altos-Lima
Peru	Site 241	La Victoria-Lima
Peru	Site 240	Lima
Peru	Site 243	San Isidro-Lima
Peru	Site 242	Surco-Lima
Romania	Site 143	Brasov
Romania	Site 140	Bucuresti
Romania	Site 141	Craiova
Romania	Site 142	Mures
Russian Federation	Site 158	Kazan
Russian Federation	Site 150	Moscow
Russian Federation	Site 151	Moscow
Russian Federation	Site 154	Moscow
Russian Federation	Site 156	Moscow
Russian Federation	Site 155	Smolensk
Russian Federation	Site 152	St Petersburg
Russian Federation	Site 157	St Petersburg
Russian Federation	Site 159	St Petersburg
Russian Federation	Site 153	Yaroslav
Serbia	Site 160	Belgrade
Serbia	Site 161	Belgrade
Serbia	Site 162	Belgrade
Serbia	Site 163	Nis
Slovakia	Site 170	Bratislava
Slovakia	Site 171	Bratislava
Slovakia	Site 174	Levice
Slovakia	Site 173	Nitra
Slovakia	Site 172	Zilina
South Africa	Site 250	Cape Town
South Africa	Site 252	Cape Town
South Africa	Site 251	Durban
South Africa	Site 253	Gauteng
South Africa	Site 254	Pretoria
Sweden	Site 127	Goteborg
Sweden	Site 126	Norrkoping
Sweden	Site 125	Stockholm
Ukraine	Site 180	Kharkiv
Ukraine	Site 183	Kharkiv
Ukraine	Site 181	Kyiv
Ukraine	Site 182	Kyiv
Ukraine	Site 185	Lviv
Ukraine	Site 184	Vinnytsya
United States	Site 288	Ashville	North Carolina
United States	Site 292	Bingham Farms	Michigan
United States	Site 289	Charlotte	North Carolina
United States	Site 290	Chicago	Illinois
United States	Site 283	Fountain Valley	California
United States	Site 279	Ft Lauderdale	Florida
United States	Site 293	Gainsville	Florida
United States	Site 272	Houston	Texas
United States	Site 284	Huntsville	Alabama
United States	Site 280	Kansas City	Kansas
United States	Site 277	La Jolla	California
United States	Site 278	Las Vegas	Nevada
United States	Site 274	Little Rock	Arkansas
United States	Site 281	Pittsburgh	Pennsylvania
United States	Site 282	Port Charlotte	Florida
United States	Site 286	Rochester	New York
United States	Site 271	San Francisco	California
United States	Site 276	St. Louis	Missouri
United States	Site 287	St. Louis	Missouri
United States	Site 285	Sunrise	Florida
United States	Site 273	Tampa	Florida
United States	Site 294	Toledo	Ohio
United States	Site 275	Traverse City	Michigan
United States	Site 291	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Finland,  India,  Israel,  Mexico,  New Zealand,  Peru,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Sweden,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment		6 months	No
Secondary	UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment		6 months	No