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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarizotan | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarizotan | Drug | Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 | Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. 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. | Week 12 |
| Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24 | Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. 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. | Week 24 |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12 | The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 12 - Baseline. | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18175337 | Result | 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. |
| Label | URL |
|---|---|
| EudraCT results summary synopsis | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sarizotan | Subjects received sarizotan 1 milligram orally twice daily for 24 weeks. |
| FG001 | Placebo | Subjects received placebo matched to sarizotan orally twice daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks. |
|
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24 |
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 24 - Baseline. |
| Baseline, Week 24 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| La Jolla | California | 92037 | United States |
| Oxnard | California | 93030 | United States |
| Sacramento | California | 95817 | United States |
| Englewood | Colorado | 80113 | United States |
| Danbury | Connecticut | 06810 | United States |
| Farmington | Connecticut | 06030-1840 | United States |
| Jacksonville | Florida | 32209 | United States |
| Jacksonville | Florida | 32216 | United States |
| Maitland | Florida | 32751 | United States |
| St. Petersburg | Florida | 33703 | United States |
| Decatur | Georgia | 30033 | United States |
| Chicago | Illinois | 60611-3078 | United States |
| Springfield | Illinois | 62702 | United States |
| Des Moines | Iowa | 50309 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Scarborough | Maine | 04074 | United States |
| Boston | Massachusetts | 02215 | United States |
| Southfield | Michigan | 48034 | United States |
| Edison | New Jersey | 08818 | United States |
| New Hyde Park | New York | 11040 | United States |
| New Hyde Park | New York | 12401 | United States |
| New York | New York | 10016 | United States |
| Durham | North Carolina | 27705 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Brentwood | Tennessee | 37027 | United States |
| South Ogden | Utah | 84403 | United States |
| Spokane | Washington | 99204 | United States |
| Milwaukee | Wisconsin | 53233 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sarizotan | Subjects received sarizotan 1 milligram orally twice daily for 24 weeks. |
| BG001 | Placebo | Subjects received placebo matched to sarizotan orally twice daily for 24 weeks. |
| BG002 | 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 | Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 | Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. 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. | Intent to treat population included all subjects who were randomized in the study. | Posted | Number | percentage of subjects | Week 12 |
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| Primary | Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24 | Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. 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. | Intent to treat population included all subjects who were randomized in the study. | Posted | Number | percentage of subjects | Week 24 |
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| ||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12 | The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 12 - Baseline. | Intent to treat population included all subjects who were randomized in the study. Here "Overall Number of Participants Analyzed" signifies those subjects who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
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| Primary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24 | The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 24 - Baseline. | Intent to treat population included all subjects who were randomized in the study. Here "Overall Number of Participants Analyzed" signifies those subjects who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
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Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
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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 | Sarizotan | Subjects received sarizotan 1 milligram orally twice daily for 24 weeks. | 23 | 252 | 100 | 252 | ||
| EG001 | Placebo | Subjects received placebo matched to sarizotan orally twice daily for 24 weeks. | 25 | 252 | 86 | 252 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Hepatic trauma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Parkinsonism | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Escherichia bacteraemia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Hernia repair | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Hip arthroplasty | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Hip surgery | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Spinal fusion surgery | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Spinal nerve stimulator implantation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Surgery | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA | Non-systematic Assessment |
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| Electrocardiogram change | Investigations | MedDRA | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA | Non-systematic Assessment |
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| Investigation | Investigations | MedDRA | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Bipolar disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Coronary artery insufficiency | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Nodal arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
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| Local swelling | General disorders | MedDRA | Non-systematic Assessment |
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| Pain | General disorders | MedDRA | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
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| Jaundice cholestatic | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyskinesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Parkinsonism | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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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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| Participants |
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