Clinical trial NCT00406588: SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa 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: 295
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease,
* advance stage of disease,
* Modified Hoehn \& Yahr stage II-IV,
* presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization

Exclusion Criteria:

* 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,
* Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,
* Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,
* Previous surgery for the treatment of PD

Primary outcomes:
measure: Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries.
timeFrame: 12 weeks
Secondary outcomes:
measure: Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 223
state: Alabama
city: LaJolla
country: United States
facility: Site 220
state: California
city: San Francisco
country: United States
facility: Site 211
state: California
city: Fort Lauderdale
country: United States
facility: Site 214
state: Florida
city: Gainsville
country: United States
facility: Site 218
state: Florida
city: Tampa
country: United States
facility: Site 213
state: Florida
city: Augusta
country: United States
facility: Site 219
state: Georgia
city: Chicago
country: United States
facility: Site 221
state: Illinois
city: Kansas City
country: United States
facility: Site 216
state: Kansas
city: Lexington
country: United States
facility: Site 224
state: Kentucky
city: East Lansing
country: United States
facility: Site 212
state: Michigan
city: St. Louis
country: United States
facility: Site 217
state: Missouri
city: Durham
country: United States
facility: Site 222
state: North Carolina
city: Toledo
country: United States
facility: Site 210
state: Ohio
city: Houston
country: United States
facility: Site 215
state: Texas
city: Buenos Aires
country: Argentina
facility: Site 100
city: Buenos Aires
country: Argentina
facility: Site 101
city: Buenos Aires
country: Argentina
facility: Site 102
city: Buenos Aires
country: Argentina
facility: Site 103
city: Buenos Aires
country: Argentina
facility: Site 106
city: Buenos Aires
country: Argentina
facility: Site 107
city: Buenos Aires
country: Argentina
facility: Site 109
city: Cordoba
country: Argentina
facility: Site 105
city: Mar del Plata
country: Argentina
facility: Site 104
city: Santa Fe
country: Argentina
facility: Site 108
city: Alto da Gloria
country: Brazil
facility: Site 114
city: Belo Horizonte
country: Brazil
facility: Site 113
city: Campinas
country: Brazil
facility: Site 112
city: Marilia
country: Brazil
facility: Site 116
city: Porto Alegre
country: Brazil
facility: Site 111
city: Porto Alegre
country: Brazil
facility: Site 118
city: Ribeirao Preto
country: Brazil
facility: Site 117
city: Salvador
country: Brazil
facility: Site 119
city: Sao Paulo
country: Brazil
facility: Site 110
city: Sao Paulo
country: Brazil
facility: Site 115
city: Sao Paulo
country: Brazil
facility: Site 125
city: Plovdiv
country: Bulgaria
facility: Site 123
city: Sofia
country: Bulgaria
facility: Site 120
city: Sofia
country: Bulgaria
facility: Site 121
city: Sofia
country: Bulgaria
facility: Site 122
city: Sofia
country: Bulgaria
facility: Site 124
city: Calgary
country: Canada
facility: Site 136
city: Greenfield Park
country: Canada
facility: Site 137
city: Halifax
country: Canada
facility: Site 133
city: Markham
country: Canada
facility: Site 132
city: Montreal
country: Canada
facility: Site 130
city: Ottawa
country: Canada
facility: Site 134
city: Peterborough
country: Canada
facility: Site 138
city: Sainte-Anne
country: Canada
facility: Site 135
city: Toronto
country: Canada
facility: Site 139
city: Windsor
country: Canada
facility: Site 131
city: Santiago de Chile
country: Chile
facility: Site 140
city: Santiago de Chile
country: Chile
facility: Site 141
city: Santiago de Chile
country: Chile
facility: Site 143
city: Valdivia
country: Chile
facility: Site 142
city: Bogota
country: Colombia
facility: Site 151
city: Bogota
country: Colombia
facility: Site 152
city: Bogota
country: Colombia
facility: Site 153
city: Bogota
country: Colombia
facility: Site 154
city: Medellin
country: Colombia
facility: Site 150
city: Riga
country: Latvia
facility: Site 160
city: Kaunas
country: Lithuania
facility: Site 172
city: Vilnius
country: Lithuania
facility: Site 170
city: Vilnius
country: Lithuania
facility: Site 171
city: Bellavista Callao
country: Peru
facility: Site 184
city: Lima
country: Peru
facility: Site 180
city: Lima
country: Peru
facility: Site 181
city: Lima
country: Peru
facility: Site 182
city: Lima
country: Peru
facility: Site 183
city: Kazan
country: Russian Federation
facility: Site 193
city: Moscow
country: Russian Federation
facility: Site 190
city: Moscow
country: Russian Federation
facility: Site 194
city: Moscow
country: Russian Federation
facility: Site 197
city: Saint Petersburg
country: Russian Federation
facility: Site 198
city: Saint-Petersburg
country: Russian Federation
facility: Site 191
city: Saint-Petersburg
country: Russian Federation
facility: Site 192
city: Saint-Petersburg
country: Russian Federation
facility: Site 195
city: Yaroslavl
country: Russian Federation
facility: Site 196
city: Dnepropetrovsk
country: Ukraine
facility: Site 204
city: Kharkiv
country: Ukraine
facility: Site 206
city: Kyiv
country: Ukraine
facility: Site 201
city: Kyiv
country: Ukraine
facility: Site 202
city: Lviv
country: Ukraine
facility: Site 205
city: Poltava
country: Ukraine
facility: Site 203
city: Simferopol
country: Ukraine
facility: Site 208
city: Vinnitsa
country: Ukraine
facility: Site 200
city: Zaporizhya
country: Ukraine
facility: Site 207
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Rascol O, Bronzova J, Hauser RA, Lang AE, Sampaio C, Theeuwes A, van de Witte SV. Pardoprunox as adjunct therapy to levodopa in patients with Parkinson's disease experiencing motor fluctuations: results of a double-blind, randomized, placebo-controlled, trial. Parkinsonism Relat Disord. 2012 May;18(4):370-6. doi: 10.1016/j.parkreldis.2011.12.006. Epub 2012 Feb 7.