Clinical trial NCT00296192: Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, Proof of Concept Trial to Assess the Tolerability, Safety, and Efficacy of Rotigotine Nasal Spray for the Acute Treatment of "OFF" Symptoms in Subjects With Advanced-Stage, Idiopathic Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Rotigotine
Rotigotine nasal spray
Efficacy, safety and tolerability
Parkinson's disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 82
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Number of Subjects Who Complete the Trial
timeFrame: 15 days
Secondary outcomes:
measure: Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination
timeFrame: Baseline, and 24 minutes post-dose
measure: Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)
timeFrame: Baseline and 34 minutes post-dose
measure: "Success Rate" (Percentage of Subjects Achieving "Off" Reversals)
timeFrame: Up to 6 hours post-dose
measure: Time of First "Off" Reversal
timeFrame: Up to 6 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: