Trial Outcomes & Findings for Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia (NCT NCT00105508)
NCT ID: NCT00105508
Last Updated: 2018-07-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
506 participants
Primary outcome timeframe
Week 12
Results posted on
2018-07-26
Participant Flow
Participant milestones
| Measure |
Sarizotan
Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
|
Placebo
Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
253
|
253
|
|
Overall Study
COMPLETED
|
213
|
217
|
|
Overall Study
NOT COMPLETED
|
40
|
36
|
Reasons for withdrawal
| Measure |
Sarizotan
Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
|
Placebo
Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
|
|---|---|---|
|
Overall Study
Prephase Dropout
|
1
|
0
|
|
Overall Study
Adverse Event
|
16
|
19
|
|
Overall Study
Insufficient Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Other
|
8
|
9
|
Baseline Characteristics
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
Baseline characteristics by cohort
| Measure |
Sarizotan
n=253 Participants
Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
|
Placebo
n=253 Participants
Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
|
Total
n=506 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.93 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 9.11 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to treat population included all subjects who were randomized in the study.
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.
Outcome measures
| Measure |
Sarizotan
n=253 Participants
Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
|
Placebo
n=253 Participants
Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
|
|---|---|---|
|
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12
|
30.4 percentage of subjects
|
33.2 percentage of subjects
|
PRIMARY outcome
Timeframe: Week 24Population: Intent to treat population included all subjects who were randomized in the study.
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.
Outcome measures
| Measure |
Sarizotan
n=253 Participants
Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
|
Placebo
n=253 Participants
Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
|
|---|---|---|
|
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24
|
37.2 percentage of subjects
|
39.5 percentage of subjects
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Sarizotan
n=253 Participants
Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
|
Placebo
n=251 Participants
Subjects received 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 12
|
0.1 units on a scale
Standard Deviation 7.45
|
-0.2 units on a scale
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: 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.
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.
Outcome measures
| Measure |
Sarizotan
n=253 Participants
Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
|
Placebo
n=251 Participants
Subjects received 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
|
-0.2 units on a scale
Standard Deviation 7.92
|
-0.0 units on a scale
Standard Deviation 6.61
|
Adverse Events
Sarizotan
Serious events: 23 serious events
Other events: 100 other events
Deaths: 0 deaths
Placebo
Serious events: 25 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sarizotan
n=252 participants at risk
Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
|
Placebo
n=252 participants at risk
Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
1.2%
3/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Injury, poisoning and procedural complications
Hepatic trauma
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Nervous system disorders
Dyskinesia
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Nervous system disorders
Dystonia
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Nervous system disorders
Parkinsonism
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Nervous system disorders
Syncope
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Infections and infestations
Cellulitis
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Infections and infestations
Urinary tract infection
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
1.2%
3/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Infections and infestations
Wound infection
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Surgical and medical procedures
Hernia repair
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Surgical and medical procedures
Spinal nerve stimulator implantation
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Surgical and medical procedures
Surgery
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.79%
2/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Gastrointestinal disorders
Constipation
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Investigations
Alanine aminotransferase increased
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Investigations
Electrocardiogram change
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Investigations
Investigation
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Investigations
Weight decreased
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Psychiatric disorders
Anxiety
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Psychiatric disorders
Bipolar disorder
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Psychiatric disorders
Depression
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Psychiatric disorders
Hallucination
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Psychiatric disorders
Psychotic disorder
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Cardiac disorders
Angina pectoris
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Cardiac disorders
Myocardial infarction
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Renal and urinary disorders
Urinary retention
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
General disorders
Asthenia
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
General disorders
Local swelling
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
General disorders
Pain
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
General disorders
Pyrexia
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
0.40%
1/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
Other adverse events
| Measure |
Sarizotan
n=252 participants at risk
Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
|
Placebo
n=252 participants at risk
Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
|
|---|---|---|
|
Nervous system disorders
Dyskinesia
|
9.5%
24/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
7.5%
19/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Nervous system disorders
Parkinsonism
|
9.5%
24/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
9.5%
24/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
28/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
8.3%
21/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Psychiatric disorders
Depression
|
6.0%
15/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
2.8%
7/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
9/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
6.0%
15/252
Safety population was used for adverse events. Safety population included those subjects who received at least 1 dose of study drug or placebo.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: 496151725200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER