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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12. |
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| Sarizotan 2 milligrams per day (mg/day) | Experimental | Participants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12. |
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| Sarizotan 4 mg/day | Experimental | Participants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12. |
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| Sarizotan 10 mg/day | Experimental | Participants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarizotan | Drug | Sarizotan will be administered twice daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85004 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17094088 | Background | 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. | |
| 18175337 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12. |
| FG001 | Sarizotan 2 mg/Day | Participants received sarizotan 2 milligrams per day (mg/day) (given in 2 divided daily doses) up to Week 12. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Placebo matching to sarizotan will be administered twice daily. |
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| Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Phoenix | Arizona | 85032 | United States |
| Scottsdale | Arizona | 85259 | United States |
| Fayetteville | Arkansas | 372703 | United States |
| Fountain Valley | California | 92708 | United States |
| Los Angeles | California | 90033 | United States |
| Fort Lauderdale | Florida | 33334 | United States |
| Hollywood | Florida | 33021 | United States |
| Ocala | Florida | 34471 | United States |
| Port Charlotte | Florida | 33952 | United States |
| St. Petersburg | Florida | 33703 | United States |
| Tampa | Florida | 33612 | United States |
| Chicago | Illinois | 60611-3078 | United States |
| Chicago | Illinois | 60612 | United States |
| Hoffman Estates | Illinois | 60194 | United States |
| Lexington | Kentucky | 40503 | United States |
| Baltimore | Maryland | 21207 | United States |
| Columbia | Maryland | 21044 | United States |
| Boston | Massachusetts | 02118-2526 | United States |
| Boston | Massachusetts | 02215 | United States |
| Golden Valley | Minnesota | 55427 | United States |
| Omaha | Nebraska | 68131 | United States |
| Albany | New York | 12205 | United States |
| New York | New York | 10003 | United States |
| Syracuse | New York | 13210 | United States |
| Toledo | Ohio | 43614-5811 | United States |
| Allentown | Pennsylvania | 18103 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Upland | Pennsylvania | 19013 | United States |
| Dallas | Texas | 75231 | United States |
| Charlottesville | Virginia | 22903 | United States |
| FG002 | Sarizotan 4 mg/Day | Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12. |
| FG003 | Sarizotan 10 mg/Day | Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12. |
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12. |
| BG001 | Sarizotan 2 mg/Day | Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12. |
| BG002 | Sarizotan 4 mg/Day | Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12. |
| BG003 | Sarizotan 10 mg/Day | Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified intent-to-treat (ITT) population included all randomized participants who received at least one treatment dose and who had at least one follow-up visit assessment for an efficacy target outcome. | Posted | Mean | Standard Deviation | hours/day | Baseline, Week 12 |
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| Secondary | 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. | Modified ITT population. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
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| Secondary | 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. | Modified ITT population. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
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| Secondary | 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. | modified ITT population. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
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Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12. | 5 | 98 | 81 | 98 | ||
| EG001 | Sarizotan 2 mg/Day | Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12. | 8 | 101 | 78 | 101 | ||
| EG002 | Sarizotan 4 mg/Day | Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12. | 7 | 97 | 75 | 97 | ||
| EG003 | Sarizotan 10 mg/Day | Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12. | 2 | 102 | 85 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders | No Coding Applied | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Parkinsonism aggravated | Nervous system disorders | No Coding Applied | Non-systematic Assessment |
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| Dyskinesia aggravated | Musculoskeletal and connective tissue disorders | No Coding Applied | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | No Coding Applied | Non-systematic Assessment |
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| Falls | Injury, poisoning and procedural complications | No Coding Applied | Non-systematic Assessment |
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| Tremor aggravated | Musculoskeletal and connective tissue disorders | No Coding Applied | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | No Coding Applied | Non-systematic Assessment |
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| Fatigue | General disorders | No Coding Applied | Non-systematic Assessment |
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| Headache | Nervous system disorders | No Coding Applied | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | No Coding Applied | Non-systematic Assessment |
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| Blood creatine protein kinase increased | Investigations | No Coding Applied | Non-systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | No Coding Applied | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | No Coding Applied | Non-systematic Assessment |
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For SAEs, due diligence was done and all potential information sources have been exhausted, no further information could be retrieved apart from what is currently reported.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center, | Merck Serono, a division of Merck KGaA | 496151725200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C443959 | sarizotan |
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| Male |
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| OG003 |
| Sarizotan 10 mg/Day |
Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12. |
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| Sarizotan 10 mg/Day |
Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12. |
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