Back to resultsSarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
Primary Purpose
Parkinson's Disease, Dyskinesia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sarizotan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Dyskinesia, Dyskinesia associated with dopaminergic treatment
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Sarizotan 2 milligrams per day (mg/day)
Sarizotan 4 mg/day
Sarizotan 10 mg/day
Arm Description
Participants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12.
Participants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12.
Participants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
Participants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Outcomes
Primary Outcome Measures
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12
On-time without dyskinesia was defined as a period (in hours) when the participant had no symptoms of off-time and was not asleep; also, participant had no difficulty in performing voluntary movements (that is, without dyskinesia). Off-time was defined as a period (in hours) when participant experienced increased parkinsonian symptoms (e.g. immobility or inability to move with ease). On-time was recorded by participant in a participant diary.
Secondary Outcome Measures
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12
Modified AIMS was a 7-item investigator-assessed scale to assess severity of dyskinesia. Each item was rated on a 0 (none) to 4 (severe) scale. Modified AIMS score was sum of the all item scores and ranged from 0 to 28, where higher score indicated increased severity. Modified AIMS score in resting state as well as with activity is reported.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.
Change From Baseline in UPDRS Part III Total Score at Week 12
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. UPDRS Part III total score was the sum of the 27 answers (rated on 0 to 4-point scale) related to motor examination, and ranged from 0-108. Higher scores indicated worse motor function. Change from baseline in UPDRS Part III total score, assessed during on-time (time when the participant has no parkinsonian symptoms) as well as off-time (time when the patient experiences increased parkinsonian symptoms), is reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00105521
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 30, 2004 (Actual)
Primary Completion Date
March 31, 2006 (Actual)
Study Completion Date
March 31, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Dyskinesia
Keywords
Parkinson's Disease, Dyskinesia, Dyskinesia associated with dopaminergic treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
398 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12.
Arm Title
Sarizotan 2 milligrams per day (mg/day)
Arm Type
Experimental
Arm Description
Participants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12.
Arm Title
Sarizotan 4 mg/day
Arm Type
Experimental
Arm Description
Participants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
Arm Title
Sarizotan 10 mg/day
Arm Type
Experimental
Arm Description
Participants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Intervention Type
Drug
Intervention Name(s)
Sarizotan
Intervention Description
Sarizotan will be administered twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to sarizotan will be administered twice daily.
Primary Outcome Measure Information:
Title
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12
Description
On-time without dyskinesia was defined as a period (in hours) when the participant had no symptoms of off-time and was not asleep; also, participant had no difficulty in performing voluntary movements (that is, without dyskinesia). Off-time was defined as a period (in hours) when participant experienced increased parkinsonian symptoms (e.g. immobility or inability to move with ease). On-time was recorded by participant in a participant diary.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12
Description
Modified AIMS was a 7-item investigator-assessed scale to assess severity of dyskinesia. Each item was rated on a 0 (none) to 4 (severe) scale. Modified AIMS score was sum of the all item scores and ranged from 0 to 28, where higher score indicated increased severity. Modified AIMS score in resting state as well as with activity is reported.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12
Description
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.
Time Frame
Baseline, Week 12
Title
Change From Baseline in UPDRS Part III Total Score at Week 12
Description
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. UPDRS Part III total score was the sum of the 27 answers (rated on 0 to 4-point scale) related to motor examination, and ranged from 0-108. Higher scores indicated worse motor function. Change from baseline in UPDRS Part III total score, assessed during on-time (time when the participant has no parkinsonian symptoms) as well as off-time (time when the patient experiences increased parkinsonian symptoms), is reported.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
372703
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3078
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21207
Country
United States
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118-2526
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614-5811
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17094088
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.
Results Reference
background
PubMed Identifier
18175337
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.
Results Reference
background
Learn more about this trial
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
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