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Phase 3 N=398 Randomized Double-blind Treatment

Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia

Parkinson's Disease · Dyskinesia

Bottom Line

View on ClinicalTrials.gov: NCT00105521 ↗
Enrolled (actual)
398
Serious AEs
5.5%
Results posted
Apr 2018
Primary outcome: Primary: Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12 — 1.6; 1.9; 1.7; 1.8 hours/day

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
Mar 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12		 1.6; 1.9; 1.7; 1.8 —
SECONDARY
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12		 -2.7; -3.0; -2.7; -3.7; -3.0; -3.3 —
SECONDARY
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12		 -1.0; -1.4; -1.1; -1.3 —
SECONDARY
Change From Baseline in UPDRS Part III Total Score at Week 12		 0.3; -0.1; -0.1; -0.8; -3.0; -1.1 —

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • The participant is an out-patient
  • The participant presents with a diagnosis of idiopathic Parkinson's disease
  • Prior therapy with all registered Parkinsonian medication is allowed

Exclusion Criteria

  • (For female participants) The participant is pregnant or lactating
  • The participant is participating in another clinical study or has done so within the past 30 days
  • The participant has received neurosurgical intervention related to Parkinson's disease
  • The participant has relevant renal impairment
  • The participant has relevant hepatic impairment
  • The participant is suffering from any dementia or psychiatric illness
  • The participant has a history of allergic asthma
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00105521). 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.

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