Phase 3
N=506
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
Parkinson's Disease · Dyskinesia
Bottom Line
View on ClinicalTrials.gov: NCT00105508 ↗Enrolled (actual)
506
Serious AEs
9.5%
Results posted
Jul 2018
Primary outcome: Primary: Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 — 30.4; 33.2 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sarizotan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- EMD Serono
- Primary completion
- Feb 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 |
30.4; 33.2 | — |
| PRIMARY Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24 |
37.2; 39.5 | — |
| PRIMARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12 |
0.1; -0.2 | — |
| PRIMARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24 |
-0.2; -0.0 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00105508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.