Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00296192
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00296192
Recruitment Status : Completed
First Posted : February 24, 2006
Results First Posted : January 29, 2010
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: Rotigotine nasal spray
Other: Placebo
Enrollment 82
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs
Hide Arm/Group Description Placebo nasal spray 1 - 4 puffs Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
Period Title: Overall Study
Started 17 16 16 17 16
Completed 17 16 16 17 16
Not Completed 0 0 0 0 0
Arm/Group Title Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs Total
Hide Arm/Group Description Placebo nasal spray 1 - 4 puffs Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine) Total of all reporting groups
Overall Number of Baseline Participants 17 16 16 17 16 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 16 participants 17 participants 16 participants 82 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  52.9%
8
  50.0%
5
  31.3%
9
  52.9%
10
  62.5%
41
  50.0%
>=65 years
8
  47.1%
8
  50.0%
11
  68.8%
8
  47.1%
6
  37.5%
41
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 16 participants 16 participants 17 participants 16 participants 82 participants
63.9  (6.94) 67.1  (7.54) 66.8  (9.67) 63.9  (8.28) 60.5  (8.04) 64.4  (8.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 16 participants 17 participants 16 participants 82 participants
Female
4
  23.5%
5
  31.3%
4
  25.0%
7
  41.2%
4
  25.0%
24
  29.3%
Male
13
  76.5%
11
  68.8%
12
  75.0%
10
  58.8%
12
  75.0%
58
  70.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 16 participants 17 participants 16 participants 82 participants
Germany 11 12 12 10 13 58
Austria 2 2 1 4 1 10
United Kingdom 1 1 2 0 2 6
Spain 3 1 1 3 0 8
1.Primary Outcome
Title Number of Subjects Who Complete the Trial
Hide Description [Not Specified]
Time Frame 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.
Arm/Group Title Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs
Hide Arm/Group Description:
Placebo nasal spray 1 - 4 puffs
Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
Overall Number of Participants Analyzed 17 16 16 17 16
Measure Type: Number
Unit of Measure: participants
17 16 16 17 16
2.Secondary Outcome
Title Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination
Hide Description 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.
Time Frame Baseline, and 24 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs
Hide Arm/Group Description:
Placebo nasal spray 1 - 4 puffs
Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
Overall Number of Participants Analyzed 17 16 16 17 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 35.1  (7.77) 37.2  (10.68) 39.5  (12.94) 36.2  (7.60) 37.6  (9.30)
24 minutes post-dose 25.3  (12.44) 30.0  (11.35) 29.2  (13.53) 29.1  (8.51) 26.4  (12.95)
Change from baseline to 24 minutes post-dose -9.8  (7.8) -7.2  (10.32) -10.3  (6.17) -7.1  (6.47) -11.6  (10.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 1 Puff
Comments Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.9
Confidence Interval 95%
-2.9 to 8.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 2 Puffs
Comments Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval 95%
-5.7 to 6.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 3 Puffs
Comments Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.9
Confidence Interval 95%
-2.8 to 8.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 4 Puffs
Comments Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.4
Confidence Interval 95%
-7.4 to 4.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)
Hide Description 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).
Time Frame Baseline and 34 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs
Hide Arm/Group Description:
Placebo nasal spray 1 - 4 puffs
Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
Overall Number of Participants Analyzed 17 16 16 17 16
Mean (Standard Deviation)
Unit of Measure: taps per minute
Baseline 112.7  (47.08) 109.8  (28.94) 127.2  (44.33) 115.9  (41.05) 118.3  (40.41)
34 minutes post-dose 141.2  (50.92) 131.0  (30.01) 138.7  (44.42) 142.9  (51.20) 144.4  (57.64)
Change from baseline to 34 minutes post-dose 28.5  (27.83) 21.2  (26.69) 11.5  (11.27) 27.1  (25.25) 22.9  (27.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 1 Puff
Comments Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.6
Confidence Interval 95%
-25.7 to 8.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 2 Puffs
Comments Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -16.8
Confidence Interval 95%
-34.0 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 3 Puffs
Comments Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.4
Confidence Interval 95%
-18.2 to 15.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 4 Puffs
Comments Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.5
Confidence Interval 95%
-23.3 to 12.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.90
Estimation Comments [Not Specified]
4.Secondary Outcome
Title "Success Rate" (Percentage of Subjects Achieving "Off" Reversals)
Hide Description 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 Frame Up to 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.
Arm/Group Title Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs
Hide Arm/Group Description:
Placebo nasal spray 1 - 4 puffs
Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
Overall Number of Participants Analyzed 17 16 16 17 16
Measure Type: Number
Unit of Measure: percentage of participants
Reversed from "off" to "on" (success) 70.6 50.0 75.0 70.6 75.0
Did not reverse from "off" to "on" 29.4 50.0 25.0 29.4 25.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 1 Puff
Comments 95% confidence interval in difference in success rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -20.6
Confidence Interval 95%
-53.3 to 12.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 2 Puffs
Comments 95% confidence interval in difference in success rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 4.4
Confidence Interval 95%
-25.9 to 34.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 3 Puffs
Comments 95% confidence interval in difference in success rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.0
Confidence Interval 95%
-30.6 to 30.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo 1-4 Puffs, Rotigotine 4 Puffs
Comments 95% confidence interval in difference in success rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 4.4
Confidence Interval 95%
-25.9 to 34.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time of First "Off" Reversal
Hide Description 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.
Time Frame Up to 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.
Arm/Group Title Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs
Hide Arm/Group Description:
Placebo nasal spray 1 - 4 puffs
Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
Overall Number of Participants Analyzed 17 16 16 17 16
Median (95% Confidence Interval)
Unit of Measure: minutes
50
(24 to 65)
60
(40 to 60)
51
(22 to 84)
50
(35 to 70)
59
(35 to 190)
Time Frame [Not Specified]
Adverse Event Reporting Description 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).
 
Arm/Group Title Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs
Hide Arm/Group Description Placebo nasal spray 1 - 4 puffs Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
All-Cause Mortality
Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/17 (0.00%)      1/17 (5.88%)      0/18 (0.00%)      1/17 (5.88%)    
Cardiac disorders           
Bradycardia * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Psychiatric disorders           
Depression * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 1-4 Puffs Rotigotine 1 Puff Rotigotine 2 Puffs Rotigotine 3 Puffs Rotigotine 4 Puffs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/13 (23.08%)      9/17 (52.94%)      5/17 (29.41%)      9/18 (50.00%)      9/17 (52.94%)    
Cardiac disorders           
Atrioventricular block first degree * 1  1/13 (7.69%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Ear and labyrinth disorders           
Vertigo * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 1/18 (5.56%)  1 0/17 (0.00%)  0
Eye disorders           
Lacrimation increased * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Eye irritation * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0
Gastrointestinal disorders           
Nausea * 1  2/13 (15.38%)  2 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 3/17 (17.65%)  6
Vomiting * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 2/17 (11.76%)  2
Salivary hypersecretion * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
General disorders           
Application site reaction * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 3/17 (17.65%)  4 0/18 (0.00%)  0 2/17 (11.76%)  2
Application site irritation * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 2/18 (11.11%)  2 0/17 (0.00%)  0
Application site dryness * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Application site paraesthesia * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Oedema peripheral * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0
Fatigue * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 1/17 (5.88%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0
Difficulty in walking * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Infections and infestations           
Urinary tract infection * 1  1/13 (7.69%)  1 1/17 (5.88%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1 1/17 (5.88%)  1
Investigations           
Blood urine present * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
White blood cells urine * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
White blood cells urine postitive * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Back pain * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0
Nervous system disorders           
Dizziness * 1  1/13 (7.69%)  1 1/17 (5.88%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1 3/17 (17.65%)  3
Somnolence * 1  1/13 (7.69%)  1 2/17 (11.76%)  2 2/17 (11.76%)  2 3/18 (16.67%)  3 1/17 (5.88%)  1
Headache * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 1/17 (5.88%)  1
Dysgeusia * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 1/17 (5.88%)  1
Balance disorder * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Dystonia * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Burning sensation * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Hypokinesia * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0
Sleep attacks * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0
Depression * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0
Anxiety * 1  1/13 (7.69%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Renal and urinary disorders           
Haematuria * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Proteinuria * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Dysuria * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Renal failure * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Nasal congestion * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 2/17 (11.76%)  2
Yawning * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1 1/17 (5.88%)  1
Skin and subcutaneous tissue disorders           
Hyperhidrosis * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 2/17 (11.76%)  2
Vascular disorders           
Hypotension * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Orthostatic hypotension * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0
Pallor * 1  0/13 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Hypertension * 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00296192    
Other Study ID Numbers: SP0873
EudraCT: 2005-004290-19 ( Other Identifier: EudraCT )
First Submitted: February 22, 2006
First Posted: February 24, 2006
Results First Submitted: July 30, 2009
Results First Posted: January 29, 2010
Last Update Posted: October 2, 2014