Trial Outcomes & Findings for Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction (NCT NCT01536015)
NCT ID: NCT01536015
Last Updated: 2014-08-01
Results Overview
Mean number of hours marked "off" during a 24-hour period.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
Baseline to 10 weeks
Results posted on
2014-08-01
Participant Flow
The total duration of the study was to be a maximum of 19 weeks for each subject, including the Screening Period (within 50 days prior to Day 1), the Titration Period (up to 3 weeks), the Maintenance Period (up to 7 weeks), and a Safety Follow-Up Visit. The Participant Flow refers to the Randomized Set which includes all randomized subjects.
A total of approximately 150 subjects were planned to be randomized in a 1:1 ratio to either Rotigotine or Placebo.
Participant milestones
| Measure |
Placebo
Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks
|
Rotigotine
Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks
|
Rotigotine
Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Inclusion Criterion not met
|
2
|
0
|
|
Overall Study
Study closure
|
5
|
5
|
Baseline Characteristics
Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks
|
Rotigotine
n=13 Participants
Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
66.7 years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
66.4 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
13 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Weight
|
84.64 kilogram
STANDARD_DEVIATION 14.93 • n=99 Participants
|
76.67 kilogram
STANDARD_DEVIATION 19.53 • n=107 Participants
|
80.50 kilogram
STANDARD_DEVIATION 17.58 • n=206 Participants
|
|
Height
|
171.79 centimeter
STANDARD_DEVIATION 13.65 • n=99 Participants
|
173.86 centimeter
STANDARD_DEVIATION 10.61 • n=107 Participants
|
172.87 centimeter
STANDARD_DEVIATION 11.95 • n=206 Participants
|
|
Body Mass Index (BMI)
|
28.714 kilogram/m^2
STANDARD_DEVIATION 4.167 • n=99 Participants
|
25.113 kilogram/m^2
STANDARD_DEVIATION 4.809 • n=107 Participants
|
26.842 kilogram/m^2
STANDARD_DEVIATION 4.785 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 10 weeksPopulation: This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
Mean number of hours marked "off" during a 24-hour period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 10 weeksPopulation: This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III is an 18-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 10 weeksPopulation: This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part IV is a 6-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 10 weeksPopulation: This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
Gastrointestinal Neurodegenerative Scale (GIND) is an 18-item scale measuring gastrointestinal dysfunction with each single item of the scale ranging from 0 (never or not at all) to 5 (very severe).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 10 weeksPopulation: This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
The Fatigue Severity Scale is a 9-item scale measuring the impact of fatigue on everyday functioning (e.g. "fatigue interferes with my work, each single item of the scale ranging from 1 (disagree) to 7 (agree).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 10 weeksPopulation: This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
The Parkinson's Disease Questionnaire (PDQ-8) is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Each single item of the 8-item questionnaire ranges from 0 (never) to 4 (always).
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Rotigotine
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=12 participants at risk
Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks
|
Rotigotine
n=13 participants at risk
Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks
|
Rotigotine
n=13 participants at risk
Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/13 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/13 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 2 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 3 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dyskinesia
|
8.3%
1/12 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
15.4%
2/13 • Number of events 5 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 3 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/13 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/13 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
1/13 • Number of events 1 • From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60