Clinical trial NCT00105521: Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
Official title: A Double-Blind, Placebo-Controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan in Patients With Parkinson's Disease Suffering From Treatment-Associated Dyskinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Dyskinesia
Keywords: Parkinson's Disease
Dyskinesia
Dyskinesia associated with dopaminergic treatment
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2005-03-16
Enrollment: 398
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: The purpose of this study is to test multiple doses of sarizotan to establish a dose with maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's disease participants.


Eligibility criteria: Inclusion Criteria:

* The participant is an out-patient
* The participant presents with a diagnosis of idiopathic Parkinson's disease
* Prior therapy with all registered Parkinsonian medication is allowed

Exclusion Criteria:

* (For female participants) The participant is pregnant or lactating
* The participant is participating in another clinical study or has done so within the past 30 days
* The participant has received neurosurgical intervention related to Parkinson's disease
* The participant has relevant renal impairment
* The participant has relevant hepatic impairment
* The participant is suffering from any dementia or psychiatric illness
* The participant has a history of allergic asthma

Primary outcomes:
measure: Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in UPDRS Part III Total Score at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Fayetteville
country: United States
state: Arkansas
city: Fountain Valley
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Fort Lauderdale
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Columbia
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Golden Valley
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Albany
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Toledo
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Upland
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
Study officials:
affiliation: EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Goetz CG, Damier P, Hicking C, Laska E, Muller T, Olanow CW, Rascol O, Russ H. Sarizotan as a treatment for dyskinesias in Parkinson's disease: a double-blind placebo-controlled trial. Mov Disord. 2007 Jan 15;22(2):179-86. doi: 10.1002/mds.21226.
citation: Goetz CG, Laska E, Hicking C, Damier P, Muller T, Nutt J, Warren Olanow C, Rascol O, Russ H. Placebo influences on dyskinesia in Parkinson's disease. Mov Disord. 2008 Apr 15;23(5):700-7. doi: 10.1002/mds.21897.