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Completed

NCT Number: NCT00296192

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotigotine nasal spray

Drug

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

Other names: Neupro, SPM 952

Placebo

Other

placebo nasal spray 1, 2 3, and 4 puffs

Primary outcomes

  1. Number of Subjects Who Complete the Trial

    Time frame: 15 days

Secondary outcomes

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

    Time frame: Baseline, and 24 minutes post-dose

    The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Examination. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 24 minute value minus baseline value.

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

    Time frame: Baseline and 34 minutes post-dose

    One-minute tapping rate will be calculated as the number of times a subject could tap on two 4 x 4 cm marks placed on a board 30 cm apart during 1 minute (30 cm measured from the inner border of the two boxes).

  3. "Success Rate" (Percentage of Subjects Achieving "Off" Reversals)

    Time frame: Up to 6 hours post-dose

    Subjects reversing from "off" to "on" following initiation of treatment. "On" and "off" state refer to periods where Parkinson's disease symptoms are not present ("on") and periods where symptoms are present ("off"); the "on"/"off" determination at each assessment timepoint was made by the investigator.

  4. Time of First "Off" Reversal

    Time frame: Up to 6 hours post-dose

    Number of minutes to first reversal of symptoms from "off" to "on". Estimated via Kaplan-Meier estimation method. "On" and "off" state refer to periods where Parkinson's disease symptoms are not present ("on") and periods where symptoms are present ("off"); the "on"/"off" determination at each assessment timepoint was made by the investigator.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 24, 2006
Registry last updated
Oct 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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