Phase 2
Completed N=44
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
Source: ClinicalTrials.gov NCT00389831 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Sep 2009
Primary outcomePrimary: Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo — 2.6; 2.2; 2.5; 2.0 score on a scale
Summary
The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo |
2.6; 2.2; 2.5; 2.0; 2.9; 2.7 | — |
| PRIMARY Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo. |
37.8; 22.6; 34.9; 19.0; 28.7; 25.4 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with idiopathic RLS, who are responding to an ongoing L-dopa treatment
Exclusion Criteria
- Patients with secondary RLS or clinically relevant concomitant diseases or medical conditions are excluded
Data sourced from ClinicalTrials.gov (NCT00389831). 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.