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Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

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ClinicalTrials.gov Identifier: NCT00295022
Recruitment Status : Completed
First Posted : February 22, 2006
Results First Posted : July 23, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB S.A. - Pharma Sector )

Tracking Information
First Submitted Date  ICMJE February 20, 2006
First Posted Date  ICMJE February 22, 2006
Results First Submitted Date  ICMJE October 10, 2017
Results First Posted Date  ICMJE July 23, 2018
Last Update Posted Date September 11, 2018
Study Start Date  ICMJE July 29, 2006
Actual Primary Completion Date October 1, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I [ Time Frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2006)
Compare the efficacy of Levocetirizine to montelukast as measured by the mean change from baseline of major symptoms (mean value) related to Seasonal Allergic Rhinitis.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • Change From Baseline in the MSC Score Over Period II [ Time Frame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] ]
    Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the MSC Score Over Period III [ Time Frame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] ]
    Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III) [ Time Frame: Baseline to Day 2 ]
    Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I [ Time Frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II [ Time Frame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III [ Time Frame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III) [ Time Frame: Baseline to Day 2 ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I [ Time Frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II [ Time Frame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III [ Time Frame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III) [ Time Frame: Baseline to Day 2 ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Individual Symptom Scores Over Period I [ Time Frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
    Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Individual Symptom Scores Over Period II [ Time Frame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] ]
    Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Individual Symptom Scores Over Period III [ Time Frame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] ]
    Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) [ Time Frame: Baseline to Day 2 ]
    Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Time to First Feeling of Improvement During Period I [ Time Frame: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
    During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms).
  • Onset of Action During Period I [ Time Frame: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
    The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time.
  • Intensity of Action From Baseline in the MSC Score Over Period I [ Time Frame: Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
    The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.
  • Intensity of Action From Baseline in the MSC Score Over Period II [ Time Frame: Treatment Period II [Day 2, from 9:30 am to 11:00 am] ]
    The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.
  • Intensity of Action From Baseline in the MSC Score Over Period III [ Time Frame: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] ]
    The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.
  • Variability of Action From Baseline in the MSC Score Over Period I [ Time Frame: Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
    The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: < 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%.
  • Variability of Action From Baseline in the MSC Score Over Period II [ Time Frame: Treatment Period II [Day 2, from 9:30 am to 11:00 am] ]
    The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: < 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%.
  • Variability of Action From Baseline in the MSC Score Over Period III [ Time Frame: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] ]
    The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: < 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%.
  • Global Satisfaction of the Subjects at the End of Period III [ Time Frame: At the end of Period III (Day 2) ]
    Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied).
  • Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season [ Time Frame: At the end of Period III (Day 2) ]
    At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: "Do you want to take the same treatment during the next pollen season?" (yes or no).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2006)
  • -Efficacy of each active arm in reducing other SAR symptoms (calculated as mean value reduction for grouped symptoms and as absolute value reduction for each individual symptom), at different time points.
  • -Safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects
Official Title  ICMJE Double-blind, Three Parallel Randomized Groups, Therapeutic Confirmatory Clinical Trial to Compare the Efficacy of Oral Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subjects Exposed to Ragweed Pollen in an Environmental Exposure Unit (EEU)
Brief Summary To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rhinitis, Allergic, Seasonal
Intervention  ICMJE
  • Drug: Placebo
    • Pharmaceutical form: Over-encapsulated tablet
    • Route of administration: Oral use
  • Drug: Montelukast
    • Pharmaceutical form: Over-encapsulated tablet
    • Concentration: 10 mg
    • Route of administration: Oral use
  • Drug: Levocetirizine
    • Pharmaceutical form: Over-encapsulated tablet
    • Concentration: 5 mg
    • Route of administration: Oral use
Study Arms  ICMJE
  • Placebo Comparator: Placebo (PBO)
    Placebo was administered orally on Days 1 and 2.
    Intervention: Drug: Placebo
  • Experimental: Montelukast (MLKT)
    10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
    Intervention: Drug: Montelukast
  • Experimental: Levocetirizine (LCTZ)
    5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
    Intervention: Drug: Levocetirizine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2017)
418
Original Enrollment  ICMJE
 (submitted: February 20, 2006)
403
Actual Study Completion Date  ICMJE October 1, 2006
Actual Primary Completion Date October 1, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
  • Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the protocol

Exclusion Criteria:

  • Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
  • Have used forbidden concomitant medications as defined by the protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00295022
Other Study ID Numbers  ICMJE A00414
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB S.A. - Pharma Sector )
Study Sponsor  ICMJE UCB S.A. - Pharma Sector
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares UCB (+1 844 599 2273)
PRS Account UCB Pharma
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP