Clinical trial NCT00335374: An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
Official title: An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Early Stage Parkinson's Disease
Keywords: Parkinson's disease
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-06-09
Enrollment: 202
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 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


Eligibility criteria: 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

Primary outcomes:
measure: Safety: laboratory data, adverse events, vital signs, ECG
timeFrame: 24 weeks
Secondary outcomes:
measure: UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 419
state: Alabama
city: Oceanside
country: United States
facility: 413
state: California
city: Oxnard
country: United States
facility: 408
state: California
city: New Haven
country: United States
facility: 422
state: Connecticut
city: Boca Raton
country: United States
facility: 403
state: Florida
city: Sarasota
country: United States
facility: 411
state: Florida
city: Augusta
country: United States
facility: 421
state: Georgia
city: Ft Wayne
country: United States
facility: 410
state: Indiana
city: Lexington
country: United States
facility: 417
state: Kentucky
city: Boston
country: United States
facility: 405
state: Massachusetts
city: Boston
country: United States
facility: 420
state: Massachusetts
city: Minneapolis
country: United States
facility: 406
state: Minnesota
city: Raleigh
country: United States
facility: 412
state: North Carolina
city: Dayton
country: United States
facility: Site 402
state: Ohio
city: Bedford Park
country: Australia
facility: 303
city: Cheltenham
country: Australia
facility: 304
city: Concord
country: Australia
facility: 301
city: East Gosford
country: Australia
facility: Site 300
city: Westmead
country: Australia
facility: 302
city: Kralove
country: Czech Republic
facility: 315
city: Olomouc
country: Czech Republic
facility: 313
city: Ostrava
country: Czech Republic
facility: 310
city: Ostrava
country: Czech Republic
facility: 314
city: Pardubice
country: Czech Republic
facility: 312
city: Plzen
country: Czech Republic
facility: 311
city: Tallinn
country: Estonia
facility: 320
city: Tartu
country: Estonia
facility: 321
city: Bochum
country: Germany
facility: 332
city: Gottingen
country: Germany
facility: 331
city: Heidelberg
country: Germany
facility: 329
city: Leipzig
country: Germany
facility: 330
city: Lubeck
country: Germany
facility: 328
city: Wiesbaden
country: Germany
facility: 326
city: Bangalore
country: India
facility: 338
city: Hyderabaad
country: India
facility: 339
city: Kerala
country: India
facility: 337
city: Mumbai
country: India
facility: 336
city: Mumbai
country: India
facility: 340
city: Grosseto
country: Italy
facility: 348
city: Lido di Camaiore
country: Italy
facility: 346
city: Pescara
country: Italy
facility: 344
city: Roma
country: Italy
facility: 343
city: Roma
country: Italy
facility: 345
city: Kaunas
country: Lithuania
facility: 428
city: Vilnius
country: Lithuania
facility: 427
city: Vilnius
country: Lithuania
facility: 429
city: Kelantan
country: Malaysia
facility: 355
city: Kuala Lumpur
country: Malaysia
facility: 357
city: Pulau Pinang
country: Malaysia
facility: 356
city: Eindhoven
country: Netherlands
facility: 364
city: Groningen
country: Netherlands
facility: 360
city: Groningen
country: Netherlands
facility: 362
city: Hertogenbosch
country: Netherlands
facility: 361
city: Gdansk
country: Poland
facility: 373
city: Kalisz
country: Poland
facility: 371
city: Katowice
country: Poland
facility: 369
city: Krakow
country: Poland
facility: 365
city: Leszno
country: Poland
facility: 368
city: Lublin
country: Poland
facility: 366
city: Mosina
country: Poland
facility: 370
city: Coimbra
country: Portugal
facility: 376
city: Lisboa
country: Portugal
facility: 375
city: Cape Town
country: South Africa
facility: 377
city: Cape Town
country: South Africa
facility: 378
city: Gauteng
country: South Africa
facility: 380
city: Pretoria
country: South Africa
facility: 381
city: Sandton
country: South Africa
facility: 379
city: Hualien
country: Taiwan
facility: 388
city: Kaohsiung Hsien
country: Taiwan
facility: 389
city: Kaohsiung
country: Taiwan
facility: 387
city: Kwei-Shan
country: Taiwan
facility: 386
city: Taipei
country: Taiwan
facility: 385
city: Bangkok
country: Thailand
facility: 391
city: Bangkok
country: Thailand
facility: 393
city: Ubonratchathani
country: Thailand
facility: 394
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: