Clinical trial NCT00335166: SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Early Stage Parkinson Disease
Keywords: Parkinson Disease
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-06-09
Enrollment: 330
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.
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: Grand Rapids
country: United States
facility: 415
state: Michigan
city: Golden Valley
country: United States
facility: 416
state: Minnesota
city: Minneapolis
country: United States
facility: 406
state: Minnesota
city: Albany
country: United States
facility: 418
state: New York
city: Charlotte
country: United States
facility: 424
state: North Carolina
city: Raleigh
country: United States
facility: 412
state: North Carolina
city: Bedford Park
country: Australia
facility: 303
city: Cheltenham
country: Australia
facility: 304
city: Concord
country: Australia
facility: 301
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: Aix en Provence
country: France
facility: 323
city: Toulon
country: France
facility: 324
city: Toulouse
country: France
facility: 325
city: Bochum
country: Germany
facility: 332
city: Gottingen
country: Germany
facility: 331
city: Heidelberg
country: Germany
facility: 329
city: Homburg
country: Germany
facility: 327
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: Hyderabad
country: India
facility: 339
city: Kerala
country: India
facility: 337
city: Mumbai
country: India
facility: 336
city: Mumbai
country: India
facility: 340
city: Arcugnano (VI)
country: Italy
facility: 347
city: Grosseto GR
country: Italy
facility: 348
city: Lido di Camaiore (LU)
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: Emmen
country: Netherlands
facility: 363
city: Groningen
country: Netherlands
facility: 362
city: Hertogenbosch
country: Netherlands
facility: 361
city: RM Groningen
country: Netherlands
facility: 360
city: Gdansk
country: Poland
facility: 373
city: Kalisz
country: Poland
facility: 371
city: Katowice
country: Poland
facility: 369
city: Katowice
country: Poland
facility: 374
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: Torun
country: Poland
facility: 367
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: Barcelona
country: Spain
facility: 383
city: Colmenar Viejo
country: Spain
facility: 384
city: San Sebastian
country: Spain
facility: 382
city: Hualien
country: Taiwan
facility: 388
city: Kaohsiung Hsien
country: Taiwan
facility: 389
city: Kaohsiung
country: Taiwan
facility: 387
city: Kweishan
country: Taiwan
facility: 386
city: Taipei
country: Taiwan
facility: 385
city: Bangkok
country: Thailand
facility: 391
city: Bangkok
country: Thailand
facility: 393
city: Ubonratchathani Province
country: Thailand
facility: 394
city: Blackpool
country: United Kingdom
facility: 396
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3.