Clinical trial NCT00407095: An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
Official title: An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Stage Parkinson's Disease
Keywords: Parkinson Disease
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 140
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety: laboratory data, adverse events, vital signs, ECG
timeFrame: 36 weeks
Secondary outcomes:
measure: On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline
timeFrame: 36 weeks
Other outcomes:
Locations:
city: LaJolla
country: United States
facility: S308.3.007 Site # 220
state: California
city: San Francisco
country: United States
facility: S308.3.007 Site # 211
state: California
city: Fort Lauderdale
country: United States
facility: S308.3.007 Site # 214
state: Florida
city: Gainsville
country: United States
facility: S308.3.007 Site # 218
state: Florida
city: Tampa
country: United States
facility: S308.3.007 Site # 213
state: Florida
city: Augusta
country: United States
facility: S308.3.007 Site # 219
state: Georgia
city: Chicago
country: United States
facility: S308.3.007 Site # 221
state: Illinois
city: Kansas City
country: United States
facility: S308.3.007 Site # 216
state: Kansas
city: Lexington
country: United States
facility: S308.3.007 Site # 224
state: Kentucky
city: East Lansing
country: United States
facility: S308.3.007 Site # 212
state: Michigan
city: St. Louis
country: United States
facility: S308.3.007 Site # 217
state: Missouri
city: Durham
country: United States
facility: S308.3.007 Site # 222
state: North Carolina
city: Tledo
country: United States
facility: S308.3.007 Site # 210
state: Ohio
city: Houston
country: United States
facility: S308.3.007 Site # 215
state: Texas
city: Birmingham
country: Albania
facility: S308.3.007 Site # 223
city: Buenos Aires
country: Argentina
facility: S308.3.007 Site # 100
city: Buenos Aires
country: Argentina
facility: S308.3.007 Site # 101
city: Buenos Aires
country: Argentina
facility: S308.3.007 Site # 102
city: Buenos Aires
country: Argentina
facility: S308.3.007 Site # 103
city: Buenos Aires
country: Argentina
facility: S308.3.007 Site # 106
city: Buenos Aires
country: Argentina
facility: S308.3.007 Site # 107
city: Buenos Aires
country: Argentina
facility: S308.3.007 Site # 109
city: Córdoba
country: Argentina
facility: S308.3.007 Site # 105
city: Mar del Plata
country: Argentina
facility: S308.3.007 Site # 104
city: Santa Fe
country: Argentina
facility: S308.3.007 Site # 108
city: Alto da Glória
country: Brazil
facility: S308.3.007 Site # 114
city: Belo Horizonte
country: Brazil
facility: S308.3.007 Site # 113
city: Campinas
country: Brazil
facility: S308.3.007 Site # 112
city: Marília
country: Brazil
facility: S308.3.007 Site # 116
city: Porto Alegre
country: Brazil
facility: S308.3.007 Site # 111
city: Porto Alegre
country: Brazil
facility: S308.3.007 Site # 118
city: Ribeirão Preto
country: Brazil
facility: S308.3.007 Site # 117
city: Salvador
country: Brazil
facility: S308.3.007 Site # 119
city: Sao Paulo
country: Brazil
facility: S308.3.007 Site # 125
city: Sâo Paulo
country: Brazil
facility: S308.3.007 Site # 115
city: São Paulo
country: Brazil
facility: S308.3.007 Site # 110
city: Plovdiv
country: Bulgaria
facility: S308.3.007 Site # 123
city: Sofia
country: Bulgaria
facility: S308.3.007 Site # 120
city: Sofia
country: Bulgaria
facility: S308.3.007 Site # 121
city: Sofia
country: Bulgaria
facility: S308.3.007 Site # 122
city: Sofia
country: Bulgaria
facility: S308.3.007 Site # 124
city: Calgary
country: Canada
facility: S308.3.007 Site # 136
city: Greenfield Park
country: Canada
facility: S308.3.007 Site # 137
city: Halifax
country: Canada
facility: S308.3.007 Site # 133
city: Markham
country: Canada
facility: S308.3.007 Site # 132
city: Montreal
country: Canada
facility: S308.3.007 Site # 130
city: Ottava
country: Canada
facility: S308.3.007 Site # 134
city: Peterborough
country: Canada
facility: S308.3.007 Site # 138
city: Sainte-Anne
country: Canada
facility: S308.3.007 Site # 135
city: Toronto
country: Canada
facility: S308.3.007 Site # 139
city: Windsor
country: Canada
facility: S308.3.007 Site # 131
city: Santiago de Chile
country: Chile
facility: S308.3.007 Site # 140
city: Santiago de Chile
country: Chile
facility: S308.3.007 Site # 141
city: Santiago de Chile
country: Chile
facility: S308.3.007 Site # 143
city: Valdivia
country: Chile
facility: S308.3.007 Site # 142
city: Bogota
country: Colombia
facility: S308.3.007 Site # 151
city: Bogota
country: Colombia
facility: S308.3.007 Site # 152
city: Bogota
country: Colombia
facility: S308.3.007 Site # 153
city: Bogota
country: Colombia
facility: S308.3.007 Site # 154
city: Medellin
country: Colombia
facility: S308.3.007 Site # 150
city: Riga
country: Latvia
facility: S308.3.007 Site # 160
city: Kaunas
country: Lithuania
facility: S308.3.007 Site # 172
city: Vilnius
country: Lithuania
facility: S308.3.007 Site # 170
city: Vilnius
country: Lithuania
facility: S308.3.007 Site # 171
city: Bellavista Callao
country: Peru
facility: S308.3.007 Site # 184
city: Lima
country: Peru
facility: S308.3.007 Site # 180
city: Lima
country: Peru
facility: S308.3.007 Site # 181
city: Lima
country: Peru
facility: S308.3.007 Site # 182
city: Lima
country: Peru
facility: S308.3.007 Site # 183
city: Kazan
country: Russian Federation
facility: S308.3.007 Site # 193
city: Moscow
country: Russian Federation
facility: S308.3.007 Site # 190
city: Moscow
country: Russian Federation
facility: S308.3.007 Site # 194
city: Moscow
country: Russian Federation
facility: S308.3.007 Site # 197
city: Saint-Petersburg
country: Russian Federation
facility: S308.3.007 Site # 191
city: Saint-Petersburg
country: Russian Federation
facility: S308.3.007 Site # 192
city: Saint-Petersburg
country: Russian Federation
facility: S308.3.007 Site # 195
city: Saint-Petersburg
country: Russian Federation
facility: S308.3.007 Site # 198
city: Yaroslavl
country: Russian Federation
facility: S308.3.007 Site # 196
city: Dnepropetrovsk
country: Ukraine
facility: S308.3.007 Site # 204
city: Kharkiv
country: Ukraine
facility: S308.3.007 Site # 206
city: Kyiv
country: Ukraine
facility: S308.3.007 Site # 201
city: Kyiv
country: Ukraine
facility: S308.3.007 Site # 202
city: Lviv
country: Ukraine
facility: S308.3.007 Site # 205
city: Poltava
country: Ukraine
facility: S308.3.007 Site # 203
city: Simferopol
country: Ukraine
facility: S308.3.007 Site # 208
city: Vinnytsya
country: Ukraine
facility: S308.3.007 Site # 200
city: Zaporozhya
country: Ukraine
facility: S308.3.007 Site # 207
Study officials:
affiliation: Abbott Products
name: Erik Vanleeuwen
role: STUDY_DIRECTOR
References: