Phase 2
Completed N=82
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms
Source: ClinicalTrials.gov NCT00296192 ↗Enrolled (actual)
82
Serious AEs
2.4%
Results posted
Jan 2010
Primary outcomePrimary: Number of Subjects Who Complete the Trial — 17; 16; 16; 17 participants
Summary
The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952) in a single dose application scheme.
Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.
The first subject is planned to be enrolled in February 2006. The last subject is planned to be enrolled in May 2006. Last subject out is expected for August 2006.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Complete the Trial |
17; 16; 16; 17; 16 | — |
| SECONDARY Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination |
35.1; 37.2; 39.5; 36.2; 37.6; 25.3 | — |
| SECONDARY Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min) |
112.7; 109.8; 127.2; 115.9; 118.3; 141.2 | — |
| SECONDARY "Success Rate" (Percentage of Subjects Achieving "Off" Reversals) |
70.6; 50.0; 75.0; 70.6; 75.0; 29.4 | — |
| SECONDARY Time of First "Off" Reversal |
50; 60; 51; 50; 59 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects with idiopathic Parkinson's disease for at least 3 years in duration
- At least 30 years of age
Exclusion Criteria
- Patients with atypical Parkinson's or clinically relevant concomitant diseases or medical conditions
Data sourced from ClinicalTrials.gov (NCT00296192). 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. Informational only — not medical advice.