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Trial record 1 of 1 for:    NCT00389831
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Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms

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ClinicalTrials.gov Identifier: NCT00389831
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : September 4, 2009
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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Restless Legs Syndrome
Interventions Drug: Rotigotine Nasal Spray
Other: Placebo Nasal Spray
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Rotigotine Nasal Spray
Hide Arm/Group Description Subjects receiving a single dose of placebo nasal spray on all 4 treatment days Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
Period Title: Overall Study
Started 10 34
Completed 10 27
Not Completed 0 7
Reason Not Completed
Lack of Efficacy             0             2
Did not receive treatment.             0             2
Other reasons             0             2
Lost to Follow-up             0             1
Arm/Group Title Placebo Rotigotine Nasal Spray Total
Hide Arm/Group Description Subjects receiving a single dose of placebo nasal spray on all 4 treatment days Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4 Total of all reporting groups
Overall Number of Baseline Participants 10 34 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 34 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  90.0%
33
  97.1%
42
  95.5%
>=65 years
1
  10.0%
1
   2.9%
2
   4.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 34 participants 44 participants
55.5  (5.40) 52.9  (7.78) 53.5  (7.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 34 participants 44 participants
Female
8
  80.0%
21
  61.8%
29
  65.9%
Male
2
  20.0%
13
  38.2%
15
  34.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 10 participants 34 participants 44 participants
10 34 44
1.Primary Outcome
Title Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo
Hide Description Subjects rate the severity of the RLS symptoms at the start of each pre dose and post dose Suggested Immobilization Test (SIT-0 to SIT-6) and every 5min during each SIT, using a numeric symptoms severity scale, where 0=not severe and 10=very severe.
Time Frame 4 hours post-treatment period at each treatment day
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Placebo - Day 1 Placebo - Day 2 Placebo - Day 3 Placebo - Day 4 Rotigotine Nasal Spray - Placebo Rotigotine Nasal Spray - Rotigotine 62µg Rotigotine Nasal Spray - Rotigotine 124µg Rotigotine Nasal Spray - Rotigotine 247µg
Hide Arm/Group Description:
Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
Overall Number of Participants Analyzed 10 10 10 10 31 31 28 28
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.6  (1.76) 2.2  (1.44) 2.5  (2.03) 2.0  (1.65) 2.9  (1.99) 2.7  (1.84) 2.0  (1.14) 1.5  (1.21)
2.Primary Outcome
Title Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.
Hide Description The Periodic Limb Movement (PLM) during Wakefulness Index (PLMWI) measures the number of limb movements per hour and indicates the frequency of PLMs when the subject is awake and the degree of motor symptoms of the disorder during wake time. No movements would result in a score of 0 PLM per hour. Outcome is the average movements per hour in the 4 hour post-dose period per subject.
Time Frame 4 hours post-treatment period at each treatment day
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Placebo - Day 1 Placebo - Day 2 Placebo - Day 3 Placebo - Day 4 Rotigotine Nasal Spray - Placebo Rotigotine Nasal Spray - Rotigotine 62µg Rotigotine Nasal Spray - Rotigotine 124µg Rotigotine Nasal Spray - Rotigotine 247µg
Hide Arm/Group Description:
Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
Overall Number of Participants Analyzed 10 10 10 10 31 31 27 28
Mean (Standard Deviation)
Unit of Measure: PLM per hour
37.8  (35.10) 22.6  (28.36) 34.9  (39.78) 19.0  (23.60) 28.7  (29.91) 25.4  (25.14) 26.2  (22.78) 20.2  (21.70)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo - Day 1 Placebo - Day 2 Placebo - Day 3 Placebo - Day 4 Rotigotine Nasal Spray - Placebo Rotigotine Nasal Spray - Rotigotine 62µg Rotigotine Nasal Spray - Rotigotine 124µg Rotigotine Nasal Spray - Rotigotine 247µg
Hide Arm/Group Description Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 1. Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 2. Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 3. Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 4. Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2. Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2. Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3. Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
All-Cause Mortality
Placebo - Day 1 Placebo - Day 2 Placebo - Day 3 Placebo - Day 4 Rotigotine Nasal Spray - Placebo Rotigotine Nasal Spray - Rotigotine 62µg Rotigotine Nasal Spray - Rotigotine 124µg Rotigotine Nasal Spray - Rotigotine 247µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo - Day 1 Placebo - Day 2 Placebo - Day 3 Placebo - Day 4 Rotigotine Nasal Spray - Placebo Rotigotine Nasal Spray - Rotigotine 62µg Rotigotine Nasal Spray - Rotigotine 124µg Rotigotine Nasal Spray - Rotigotine 247µg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/31 (0.00%)      0/31 (0.00%)      0/28 (0.00%)      0/28 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo - Day 1 Placebo - Day 2 Placebo - Day 3 Placebo - Day 4 Rotigotine Nasal Spray - Placebo Rotigotine Nasal Spray - Rotigotine 62µg Rotigotine Nasal Spray - Rotigotine 124µg Rotigotine Nasal Spray - Rotigotine 247µg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/10 (40.00%)      3/10 (30.00%)      2/10 (20.00%)      2/10 (20.00%)      16/31 (51.61%)      14/31 (45.16%)      10/28 (35.71%)      11/28 (39.29%)    
Cardiac disorders                 
Palpitations * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 1/28 (3.57%)  2 0/28 (0.00%)  0
Eye disorders                 
Eye irritation * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Gastrointestinal disorders                 
Diarrhoea * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 2/31 (6.45%)  2 0/31 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0
Dyspepsia * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/31 (3.23%)  1 0/31 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0
Flatulence * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/31 (3.23%)  1 1/31 (3.23%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Abdominal pain * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0
Abdominal pain upper * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 1/28 (3.57%)  1 1/28 (3.57%)  1
Abdominal discomfort * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Nausea * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/31 (6.45%)  2 2/31 (6.45%)  2 1/28 (3.57%)  1 1/28 (3.57%)  1
General disorders                 
Application site irritation * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Application site reaction * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Fatigue * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/31 (3.23%)  1 1/31 (3.23%)  1 1/28 (3.57%)  1 0/28 (0.00%)  0
Chest discomfort * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Catheter site pain * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/31 (6.45%)  2 0/31 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0
Infections and infestations                 
Rhinitis * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/31 (3.23%)  1 0/31 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0
Injury, poisoning and procedural complications                 
Arthropod bite * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Investigations                 
Bacteria urine identified * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
White blood cells urine positive * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Musculoskeletal and connective tissue disorders                 
Arthralgia * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Back pain * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 3/31 (9.68%)  3 3/31 (9.68%)  3 0/28 (0.00%)  0 2/28 (7.14%)  2
Neck pain * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0
Pain in extremity * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Nervous system disorders                 
Headache * 1  3/10 (30.00%)  3 2/10 (20.00%)  2 0/10 (0.00%)  0 2/10 (20.00%)  3 9/31 (29.03%)  10 5/31 (16.13%)  6 3/28 (10.71%)  4 3/28 (10.71%)  3
Sciatica * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1 1/28 (3.57%)  1 0/28 (0.00%)  0
Dizziness * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/31 (3.23%)  1 0/31 (0.00%)  0 2/28 (7.14%)  2 2/28 (7.14%)  2
Paraesthesia * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0
Restlessness * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Sleep disorder * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Nasal congestion * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 1/31 (3.23%)  1 0/31 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0
Sneezing * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Cold sweat * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Hyperhidrosis * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Vascular disorders                 
Pallor * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
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 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: NCT00389831    
Other Study ID Numbers: SP0879
2006-001937-17 ( EudraCT Number )
First Submitted: October 17, 2006
First Posted: October 19, 2006
Results First Submitted: July 28, 2009
Results First Posted: September 4, 2009
Last Update Posted: October 2, 2014