Dyskinesia, Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Dyskinesia, Dyskinesia associated with dopaminergic 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).
Interventions
DRUGSarizotan
Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.
DRUGPlacebo
Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.
Sponsors
EMD Serono
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 | 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. |
| Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24 | 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. |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12 | Baseline, 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. |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24 | Baseline, 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sarizotan Subjects received sarizotan 1 milligram orally twice daily for 24 weeks. | 253 |
| Placebo Subjects received placebo matched to sarizotan orally twice daily for 24 weeks. | 253 |
| Total | 506 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 16 | 19 |
| Overall Study | Insufficient Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Other | 8 | 9 |
| Overall Study | Prephase Dropout | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 10 | 6 |
Baseline characteristics
| Characteristic | Sarizotan | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 9.93 | 65.0 years STANDARD_DEVIATION 9.11 | 64.1 years STANDARD_DEVIATION 9.56 |
| Sex: Female, Male Female | 126 Participants | 112 Participants | 238 Participants |
| Sex: Female, Male Male | 127 Participants | 141 Participants | 268 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 100 / 252 | 86 / 252 |
| serious Total, serious adverse events | 23 / 252 | 25 / 252 |
Outcome results
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sarizotan | 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 |
| Placebo | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12 | -0.2 units on a scale | Standard Deviation 0 |
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.
Time frame: Baseline, Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sarizotan | 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 |
| Placebo | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24 | -0.0 units on a scale | Standard Deviation 6.61 |
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.
Time frame: Week 12
Population: Intent to treat population included all subjects who were randomized in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sarizotan | Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 | 30.4 percentage of subjects |
| Placebo | Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 | 33.2 percentage of subjects |
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.
Time frame: Week 24
Population: Intent to treat population included all subjects who were randomized in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sarizotan | Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24 | 37.2 percentage of subjects |
| Placebo | Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24 | 39.5 percentage of subjects |