Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms

UCB

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Other: Placebo; Drug: Rotigotine nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00296192

EudraCT: 2005-004290-19 (Other Identifier)

SP0873

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

82 participants in 5 patient groups, including a placebo group

Placebo 1

Placebo Comparator group

Description:

Placebo nasal spray 1 - 4 puffs

Treatment:

Other: Placebo

Rotigotine 1

Experimental group

Description:

Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)

Treatment:

Drug: Rotigotine nasal spray

Rotigotine 2

Experimental group

Description:

Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)

Treatment:

Drug: Rotigotine nasal spray

Rotigotine 3

Experimental group

Description:

Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)

Treatment:

Drug: Rotigotine nasal spray

Rotigotine 4

Experimental group

Description:

Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)

Treatment:

Drug: Rotigotine nasal spray