Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Rotigotine nasal spray Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Number of Subjects Who Complete the Trial [ Time Frame: 15 days ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]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.
- Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min) [ Time Frame: Baseline and 34 minutes post-dose ] [ Designated as safety issue: No ]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).
- "Success Rate" (Percentage of Subjects Achieving "Off" Reversals) [ Time Frame: Up to 6 hours post-dose ] [ Designated as safety issue: No ]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.
- Time of First "Off" Reversal [ Time Frame: Up to 6 hours post-dose ] [ Designated as safety issue: No ]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.
| Enrollment: | 82 |
| Study Start Date: | February 2006 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo 1
Placebo nasal spray 1 - 4 puffs
|
Other: Placebo
placebo nasal spray 1, 2 3, and 4 puffs
|
|
Experimental: Rotigotine 1
Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
|
Drug: Rotigotine nasal spray
Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries
Other Names:
|
|
Experimental: Rotigotine 2
Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
|
Drug: Rotigotine nasal spray
Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries
Other Names:
|
|
Experimental: Rotigotine 3
Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
|
Drug: Rotigotine nasal spray
Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries
Other Names:
|
|
Experimental: Rotigotine 4
Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
|
Drug: Rotigotine nasal spray
Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries
Other Names:
|
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| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00296192 History of Changes |
| Other Study ID Numbers: | SP873, EudraCT: 2005-004290-19 |
| Study First Received: | February 22, 2006 |
| Results First Received: | July 30, 2009 |
| Last Updated: | May 25, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Austria: Agency for Health and Food Safety Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by UCB, Inc.:
|
Rotigotine Rotigotine nasal spray Efficacy, safety and tolerability Parkinson's disease |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
N 0437 Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013