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Trial record 1 of 1 for:    NCT00464737
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The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults. (SP888)

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: NCT00464737
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : January 5, 2010
Last Update Posted : June 22, 2015
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 Fibromyalgia Syndrome
Interventions Drug: Rotigotine
Other: Placebo
Enrollment 230
Recruitment Details The Full Analysis Set (FAS) contains all randomized subjects who received at least 1 dose of trial medication, and had at least 1 post-Baseline Likert pain score. The Per Protocol Set contains all subjects in the FAS who completed at least 2 weeks of the Maintenance Phase and had no major protocol deviations.
Pre-assignment Details Participant flow is based on the 230 randomized subjects however 1 subject randomized to Rotigotine 4 mg/24 hrs did not receive study medication and was excluded from the Safety Set. Thus 229 subjects are included in summaries of baseline characteristics and adverse events. The excluded subject was a 47-year old female enrolled in the United States
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description Placebo Rotigotine 4 mg/24 hrs Rotigotine 8 mg/24 hrs
Period Title: Overall Study
Started 82 74 74
Completed 50 42 19
Not Completed 32 32 55
Reason Not Completed
Adverse Event             12             17             33
Lack of Efficacy             7             7             4
Withdrawal by Subject             5             3             5
Protocol Violation             1             1             5
Non-compliance             0             1             1
Lost to Follow-up             5             2             5
Other: Subject's schedule doesn't permit             1             0             0
Other: Subject left town; family illness             1             0             0
Other: Study demands too great             0             1             0
Other: Personal family reasons             0             0             1
Other: Subject's disability per sponsor             0             0             1
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg Total
Hide Arm/Group Description Placebo Rotigotine 4 mg/24 hrs Rotigotine 8 mg/24 hrs Total of all reporting groups
Overall Number of Baseline Participants 82 73 74 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 73 participants 74 participants 229 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
81
  98.8%
73
 100.0%
73
  98.6%
227
  99.1%
>=65 years
1
   1.2%
0
   0.0%
1
   1.4%
2
   0.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 73 participants 74 participants 229 participants
46.4  (10.7) 47.5  (10.3) 47.0  (11.6) 47.0  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 73 participants 74 participants 229 participants
Female
76
  92.7%
65
  89.0%
68
  91.9%
209
  91.3%
Male
6
   7.3%
8
  11.0%
6
   8.1%
20
   8.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 82 participants 73 participants 74 participants 229 participants
82 73 74 229
1.Primary Outcome
Title Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)
Hide Description The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame Baseline, Last 2 weeks of the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 81 70 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.12  (1.83) -1.27  (1.86) -0.83  (1.70)
2.Primary Outcome
Title Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)
Hide Description The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame Baseline, Last 2 weeks of the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 50, 33 and 22 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 50 33 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.28  (1.79) -2.09  (2.07) -1.57  (2.27)
3.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase
Hide Description The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 80, 64 and 63 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 80 64 63
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-14.9  (15.6) -13.4  (13.7) -12.8  (18.1)
4.Secondary Outcome
Title Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase
Hide Description Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase
Hide Description Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)
Time Frame Baseline, Last 2 weeks of the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 81 70 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.95  (2.01) -0.82  (2.03) -0.48  (2.09)
6.Secondary Outcome
Title Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase
Hide Description General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)
Time Frame Baseline, Last 2 weeks of the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 81 70 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.11  (2.05) -1.19  (1.82) -0.88  (2.10)
7.Secondary Outcome
Title Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase
Hide Description The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 76, 58, and 51 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 76 58 51
Measure Type: Number
Unit of Measure: Patients
Much better 8 10 9
Moderately better 14 14 7
Mildly better 25 12 11
No change 16 17 12
Mildly worse 5 3 5
Moderately worse 7 1 5
Much worse 1 1 2
8.Secondary Outcome
Title Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase
Hide Description An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame Baseline, Last 2 weeks of the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 81 70 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Morning Pain Score -1.07  (1.91) -1.30  (1.91) -0.78  (1.78)
Evening Pain Score -1.17  (1.82) -1.24  (1.90) -0.88  (1.89)
9.Secondary Outcome
Title Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase
Hide Description Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response. Use of alcohol to treat pain in the past 24 hours was recorded with a Yes/No response.
Time Frame 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12
Hide Description [Not Specified]
Time Frame End of the Maintenance Phase/Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients in the Placebo group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 73 (Rotigotine 4 mg) and 74 (Rotigotine 8 mg) patients respectively in the Safety Set, a total of 41 and 20 patients respectively at the end of Maintenance Phase/Week 12 have this assessment.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 0 41 20
Mean (Standard Deviation)
Unit of Measure: ug/ML
0.2388  (0.2337) 0.2981  (0.2973)
11.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase
Hide Description The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase
Hide Description All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase
Hide Description The Beck Depression Inventory-II is a 21-item questionnaire. Each item is scored on a scale of 0 to 3 with a total score ranging from 0 to 63. A higher total score is associated with more severe depressive symptoms.
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Number of Subjects With Presence of Impulse Control Disorders
Hide Description Impulse control disorders (ICDs) are a set of psychiatric disorders in which a person is unable to control strong and often harmful impulses. They are assessed in this study using the Jay Modified Minnesota Impulsive Disorders Interview (Jay Modified MIDI), which focuses on the five most common ICDs that may be associated with dopamine agonist use: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding (performing repetitive and/or mechanical tasks).
Time Frame 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description:
Placebo
Rotigotine 4 mg/24 hrs
Rotigotine 8 mg/24 hrs
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Set (SS) is comprised of all subjects who received at least 1 dose of trial medication.
 
Arm/Group Title Placebo Rotigotine 4 mg Rotigotine 8 mg
Hide Arm/Group Description Placebo Rotigotine 4 mg/24 hrs Rotigotine 8 mg/24 hrs
All-Cause Mortality
Placebo Rotigotine 4 mg Rotigotine 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Rotigotine 4 mg Rotigotine 8 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/82 (4.88%)      1/73 (1.37%)      1/74 (1.35%)    
General disorders       
Chest pain * 1  0/82 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis * 1  0/82 (0.00%)  0 0/73 (0.00%)  0 1/74 (1.35%)  1
Infections and infestations       
Pneumonia * 1  1/82 (1.22%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0
Injury, poisoning and procedural complications       
Ankle fracture * 1  1/82 (1.22%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0
Lung injury * 1  1/82 (1.22%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0
Rib fracture * 1  1/82 (1.22%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion * 1  1/82 (1.22%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0
Nervous system disorders       
Intracranial hypotension * 1  1/82 (1.22%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0
Nerve compression * 1  1/82 (1.22%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0
Trigeminal neuralgia * 1  1/82 (1.22%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pleural effusion * 1  1/82 (1.22%)  2 0/73 (0.00%)  0 0/74 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rotigotine 4 mg Rotigotine 8 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/82 (64.63%)      55/73 (75.34%)      65/74 (87.84%)    
Gastrointestinal disorders       
Abdominal pain upper * 1  2/82 (2.44%)  3 0/73 (0.00%)  0 4/74 (5.41%)  4
Constipation * 1  5/82 (6.10%)  6 5/73 (6.85%)  5 5/74 (6.76%)  6
Diarrhoea * 1  6/82 (7.32%)  7 5/73 (6.85%)  5 8/74 (10.81%)  8
Dry mouth * 1  3/82 (3.66%)  3 5/73 (6.85%)  6 7/74 (9.46%)  7
Nausea * 1  18/82 (21.95%)  25 34/73 (46.58%)  46 48/74 (64.86%)  63
Vomiting * 1  1/82 (1.22%)  1 13/73 (17.81%)  15 18/74 (24.32%)  22
General disorders       
Application site irritation * 1  1/82 (1.22%)  1 6/73 (8.22%)  6 5/74 (6.76%)  6
Application site pruritus * 1  4/82 (4.88%)  5 3/73 (4.11%)  3 11/74 (14.86%)  11
Fatigue * 1  2/82 (2.44%)  4 5/73 (6.85%)  6 1/74 (1.35%)  1
Infections and infestations       
Sinusitis * 1  6/82 (7.32%)  7 2/73 (2.74%)  2 0/74 (0.00%)  0
Upper respiratory tract infection * 1  1/82 (1.22%)  1 7/73 (9.59%)  7 2/74 (2.70%)  3
Musculoskeletal and connective tissue disorders       
Muscle spasms * 1  5/82 (6.10%)  5 2/73 (2.74%)  2 4/74 (5.41%)  4
Nervous system disorders       
Dizziness * 1  6/82 (7.32%)  6 10/73 (13.70%)  10 8/74 (10.81%)  10
Headache * 1  12/82 (14.63%)  17 13/73 (17.81%)  18 12/74 (16.22%)  15
Somnolence * 1  6/82 (7.32%)  6 8/73 (10.96%)  9 7/74 (9.46%)  9
Psychiatric disorders       
Anxiety * 1  2/82 (2.44%)  2 1/73 (1.37%)  1 4/74 (5.41%)  4
Insomnia * 1  4/82 (4.88%)  4 6/73 (8.22%)  10 7/74 (9.46%)  9
Respiratory, thoracic and mediastinal disorders       
Hiccups * 1  0/82 (0.00%)  0 3/73 (4.11%)  3 4/74 (5.41%)  7
Skin and subcutaneous tissue disorders       
Pruritus * 1  1/82 (1.22%)  1 4/73 (5.48%)  4 4/74 (5.41%)  4
Rash * 1  5/82 (6.10%)  6 3/73 (4.11%)  3 4/74 (5.41%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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 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
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00464737    
Other Study ID Numbers: SP888
First Submitted: April 23, 2007
First Posted: April 24, 2007
Results First Submitted: November 23, 2009
Results First Posted: January 5, 2010
Last Update Posted: June 22, 2015