NCT00296192

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

January 29, 2010

Completed
Last Updated

October 2, 2014

Status Verified

February 1, 2011

Enrollment Period

4 months

First QC Date

February 22, 2006

Results QC Date

July 30, 2009

Last Update Submit

September 24, 2014

Conditions

Parkinson's Disease

Keywords

RotigotineRotigotine nasal sprayEfficacy, safety and tolerabilityParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Who Complete the Trial

    15 days

Secondary Outcomes (4)

  • Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination

    Baseline, and 24 minutes post-dose

  • Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)

    Baseline and 34 minutes post-dose

  • "Success Rate" (Percentage of Subjects Achieving "Off" Reversals)

    Up to 6 hours post-dose

  • Time of First "Off" Reversal

    Up to 6 hours post-dose

Study Arms (5)

Placebo 1

PLACEBO COMPARATOR

Placebo nasal spray 1 - 4 puffs

Other: Placebo

Rotigotine 1

EXPERIMENTAL

Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)

Drug: Rotigotine nasal spray

Rotigotine 2

EXPERIMENTAL

Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)

Drug: Rotigotine nasal spray

Rotigotine 3

EXPERIMENTAL

Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)

Drug: Rotigotine nasal spray

Rotigotine 4

EXPERIMENTAL

Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)

Drug: Rotigotine nasal spray

Interventions

Rotigotine nasal sprayDRUG

Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries

Also known as: Neupro, SPM 952
Rotigotine 1Rotigotine 2Rotigotine 3Rotigotine 4
PlaceboOTHER

placebo nasal spray 1, 2 3, and 4 puffs

Placebo 1

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects with idiopathic Parkinson's disease for at least 3 years in duration
  • At least 30 years of age

You may not qualify if:

  • Patients with atypical Parkinson's or clinically relevant concomitant diseases or medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB Pharma
+1 877 822 9493

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2006

First Posted

February 24, 2006

Study Start

February 1, 2006

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

October 2, 2014

Results First Posted

January 29, 2010

Record last verified: 2011-02