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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2005-004290-19 | Other Identifier | EudraCT |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo 1 | Placebo Comparator | Placebo nasal spray 1 - 4 puffs |
|
| Rotigotine 1 | Experimental | Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) |
|
| Rotigotine 2 | Experimental | Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) |
|
| Rotigotine 3 | Experimental | Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) |
|
| Rotigotine 4 | Experimental | Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine nasal spray | Drug | Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Complete the Trial | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination | 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. | Baseline, and 24 minutes post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participants flow shows all subjects randomized. Safety analyses are based on actual treatment received; 4 subjects randomized to placebo were mistreated (1 subject each in the rotigotine 1 puff, rotigotine 2 puffs, rotigotine 3 puffs, and rotigotine 4 puffs treatment arms).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo 1-4 Puffs | Placebo nasal spray 1 - 4 puffs |
| FG001 | Rotigotine 1 Puff | Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) |
| FG002 | Rotigotine 2 Puffs | Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) |
| FG003 | Rotigotine 3 Puffs | Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) |
| FG004 | Rotigotine 4 Puffs | Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo 1-4 Puffs | Placebo nasal spray 1 - 4 puffs |
| BG001 | Rotigotine 1 Puff | Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Who Complete the Trial | Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. | Number | participants | 15 days |
|
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Safety analyses are based on actual treatment received; 4 subjects randomized to placebo were mistreated (1 subject each in the rotigotine 1 puff, rotigotine 2 puffs, rotigotine 3 puffs, and rotigotine 4 puffs treatment arms).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo 1-4 Puffs | Placebo nasal spray 1 - 4 puffs |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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|
| Placebo | Other | placebo nasal spray 1, 2 3, and 4 puffs |
|
| Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min) | 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). | Baseline and 34 minutes post-dose |
| "Success Rate" (Percentage of Subjects Achieving "Off" Reversals) | 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. | Up to 6 hours post-dose |
| Time of First "Off" Reversal | 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. | Up to 6 hours post-dose |
| BG002 | Rotigotine 2 Puffs | Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) |
| BG003 | Rotigotine 3 Puffs | Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) |
| BG004 | Rotigotine 4 Puffs | Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine) |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Rotigotine 3 Puffs | Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) |
| OG004 | Rotigotine 4 Puffs | Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine) |
|
|
| Secondary | Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination | 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. | Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 24 minutes post-dose timepoint were not imputed; number of observations at 24 minutes post-dose timepoint may be less than that for baseline timepoint. | Mean | Standard Deviation | score on a scale | Baseline, and 24 minutes post-dose |
|
|
|
|
| Secondary | Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min) | 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). | Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 34 minutes post-dose timepoint were not imputed; number of observations at 34 minutes post-dose timepoint may be less than that for baseline timepoint. | Mean | Standard Deviation | taps per minute | Baseline and 34 minutes post-dose |
|
|
|
|
| Secondary | "Success Rate" (Percentage of Subjects Achieving "Off" Reversals) | 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. | Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. | Number | percentage of participants | Up to 6 hours post-dose |
|
|
|
|
| Secondary | Time of First "Off" Reversal | 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. | Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. | Median | 95% Confidence Interval | minutes | Up to 6 hours post-dose |
|
|
|
| 0 |
| 13 |
| 3 |
| 13 |
| EG001 | Rotigotine 1 Puff | Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) | 0 | 17 | 9 | 17 |
| EG002 | Rotigotine 2 Puffs | Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) | 1 | 17 | 5 | 17 |
| EG003 | Rotigotine 3 Puffs | Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) | 0 | 18 | 9 | 18 |
| EG004 | Rotigotine 4 Puffs | Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine) | 1 | 17 | 9 | 17 |
| Depression | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Application site reaction | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Application site dryness | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Application site paraesthesia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Difficulty in walking | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| White blood cells urine | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| White blood cells urine postitive | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Back pain | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hypokinesia | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Sleep attacks | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Depression | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Anxiety | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.0 | Non-systematic Assessment |
|
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| 24 minutes post-dose |
|
| Change from baseline to 24 minutes post-dose |
|
Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.
| ANCOVA |
| Mean Difference (Net) |
| 0.1 |
| Standard Error of the Mean |
| 2.93 |
| 95 |
| -5.7 |
| 6.0 |
| No |
| Superiority or Other |
| Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value. | ANCOVA | Mean Difference (Net) | 2.9 | Standard Error of the Mean | 2.86 | 95 | -2.8 | 8.6 | No | Superiority or Other |
| Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value. | ANCOVA | Mean Difference (Net) | -1.4 | Standard Error of the Mean | 3.02 | 95 | -7.4 | 4.6 | No | Superiority or Other |
| 34 minutes post-dose |
|
| Change from baseline to 34 minutes post-dose |
|
Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.
| ANCOVA |
| Mean Difference (Net) |
| -16.8 |
| Standard Error of the Mean |
| 8.63 |
| 95 |
| -34.0 |
| 0.4 |
| No |
| Superiority or Other |
| Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value. | ANCOVA | Mean Difference (Net) | -1.4 | Standard Error of the Mean | 8.45 | 95 | -18.2 | 15.4 | No | Superiority or Other |
| Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value. | ANCOVA | Mean Difference (Net) | -5.5 | Standard Error of the Mean | 8.90 | 95 | -23.3 | 12.2 | No | Superiority or Other |
| Did not reverse from "off" to "on" |
|
| Difference in proportions |
| 4.4 |
| 95 |
| -25.9 |
| 34.7 |
| No |
| Superiority or Other |
| 95% confidence interval in difference in success rate | 95% confidence interval | Difference in proportions | 0.0 | 95 | -30.6 | 30.6 | No | Superiority or Other |
| 95% confidence interval in difference in success rate | 95% confidence interval | Difference in proportions | 4.4 | 95 | -25.9 | 34.7 | No | Superiority or Other |