Clinical trial NCT00105508: Sarizotan HC1 in Patients 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 HCl 1 mg b.i.d. 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: 506
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 determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12
timeFrame: Week 12
measure: Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24
timeFrame: Week 24
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: La Jolla
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: Farmington
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: New Orleans
country: United States
state: Louisiana
city: Scarborough
country: United States
state: Maine
city: Boston
country: United States
state: Massachusetts
city: Southfield
country: United States
state: Michigan
city: Edison
country: United States
state: New Jersey
city: New Hyde Park
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Pittsburgh
country: United States
state: Pennsylvania
city: Brentwood
country: United States
state: Tennessee
city: South Ogden
country: United States
state: Utah
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
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.