Trial Outcomes & Findings for An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease (NCT NCT00505687)
NCT ID: NCT00505687
Last Updated: 2014-10-02
Results Overview
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
186 participants
Primary outcome timeframe
four years
Results posted on
2014-10-02
Participant Flow
An Open-Label Extension Trial to Assess the Safety and Tolerability of Long-term Treatment of Rotigotine in Subjects with Idiopathic Parkinson's Disease in 26 locations from February 2005 to December 2008.
Participant milestones
| Measure |
Rotigotine
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Overall Study
STARTED
|
186
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
95
|
Reasons for withdrawal
| Measure |
Rotigotine
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Overall Study
Important protocol violation
|
2
|
|
Overall Study
Lack of Efficacy
|
15
|
|
Overall Study
Adverse Event
|
48
|
|
Overall Study
Subject withdrew consent
|
15
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Other: Underwent Implantation Of DBS
|
1
|
|
Overall Study
Other: Scheduled DBS Surgery
|
1
|
|
Overall Study
Other: Prolonged Hospitalization
|
1
|
|
Overall Study
Other: Patches Would Not Stick D/T Sweat
|
1
|
|
Overall Study
Other: Neupro Given In Hospital
|
1
|
|
Overall Study
Other: Disease Progression
|
1
|
|
Overall Study
Other: As Per Sponsor
|
8
|
Baseline Characteristics
An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Rotigotine
n=186 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
92 Participants
n=5 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: four yearsPopulation: Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Outcome measures
| Measure |
Rotigotine
n=186 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
|
170 Subjects
|
SECONDARY outcome
Timeframe: four yearsPopulation: Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Outcome measures
| Measure |
Rotigotine
n=186 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
|
48 Subjects
|
SECONDARY outcome
Timeframe: Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)Population: Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.
Outcome measures
| Measure |
Rotigotine
n=186 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
End of Treatment (n=182)
|
10.1 Score on a scale
Standard Deviation 5.9
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Visit 6 (post year 1) (n=164)
|
9.3 Score on a scale
Standard Deviation 5.6
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Visit 10 (post year 2) (n=164)
|
10.0 Score on a scale
Standard Deviation 5.9
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Visit 14 (post year 3) (n=164)
|
10.3 Score on a scale
Standard Deviation 6.1
|
Adverse Events
Rotigotine
Serious events: 45 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotigotine
n=186 participants at risk
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Cardiac disorders
Angina pectoris
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Cardiac disorders
Myocardial infarction
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Cardiac disorders
Coronary artery occlusion
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Cardiac disorders
Atrial fibrillation
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Gastrointestinal disorders
Constipation
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Gastrointestinal disorders
Gastritis
|
0.54%
1/186 • Number of events 2 • up to four years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
General disorders
Asthenia
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
General disorders
Pyrexia
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
General disorders
Chest pain
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Infections and infestations
Cellulitis
|
1.1%
2/186 • Number of events 3 • up to four years
|
|
Infections and infestations
Septic shock
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Infections and infestations
Urosepsis
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Infections and infestations
Pneumonia
|
0.54%
1/186 • Number of events 2 • up to four years
|
|
Infections and infestations
Urinary tract infection
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
2/186 • Number of events 2 • up to four years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
3/186 • Number of events 4 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
2/186 • Number of events 2 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Toe deformity
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.54%
1/186 • Number of events 2 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the small bowel
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant fibrous histiocytoma
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.54%
1/186 • Number of events 2 • up to four years
|
|
Nervous system disorders
Parkinson's disease
|
1.6%
3/186 • Number of events 3 • up to four years
|
|
Nervous system disorders
Parkinsonism
|
1.1%
2/186 • Number of events 3 • up to four years
|
|
Nervous system disorders
Syncope
|
1.1%
2/186 • Number of events 2 • up to four years
|
|
Nervous system disorders
Hypokinesia
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Nervous system disorders
Dyskinesia
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Nervous system disorders
Hydrocephalus
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Nervous system disorders
Tremor
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Nervous system disorders
Balance disorder
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Psychiatric disorders
Abnormal behaviour
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Psychiatric disorders
Depression
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Psychiatric disorders
Completed suicide
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Renal and urinary disorders
Urinary retention
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Renal and urinary disorders
Pollakiuria
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Renal and urinary disorders
Urge incontinence
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Renal and urinary disorders
Renal failure
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Renal and urinary disorders
Renal colic
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.54%
1/186 • Number of events 1 • up to four years
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.54%
1/186 • Number of events 1 • up to four years
|
Other adverse events
| Measure |
Rotigotine
n=186 participants at risk
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
11.3%
21/186 • Number of events 27 • up to four years
|
|
Gastrointestinal disorders
Constipation
|
6.5%
12/186 • Number of events 14 • up to four years
|
|
General disorders
Oedema peripheral
|
19.4%
36/186 • Number of events 45 • up to four years
|
|
General disorders
Application site erythema
|
12.9%
24/186 • Number of events 26 • up to four years
|
|
General disorders
Application site pruritus
|
8.6%
16/186 • Number of events 17 • up to four years
|
|
General disorders
Fatigue
|
5.4%
10/186 • Number of events 11 • up to four years
|
|
Injury, poisoning and procedural complications
Fall
|
15.6%
29/186 • Number of events 47 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.3%
21/186 • Number of events 24 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
12/186 • Number of events 14 • up to four years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
14/186 • Number of events 16 • up to four years
|
|
Nervous system disorders
Somnolence
|
28.0%
52/186 • Number of events 58 • up to four years
|
|
Nervous system disorders
Dizziness
|
9.7%
18/186 • Number of events 19 • up to four years
|
|
Nervous system disorders
Parkinson's disease
|
5.4%
10/186 • Number of events 13 • up to four years
|
|
Psychiatric disorders
Insomnia
|
12.9%
24/186 • Number of events 25 • up to four years
|
|
Psychiatric disorders
Depression
|
10.2%
19/186 • Number of events 20 • up to four years
|
|
Psychiatric disorders
Anxiety
|
8.6%
16/186 • Number of events 20 • up to four years
|
|
Psychiatric disorders
Hallucination
|
5.9%
11/186 • Number of events 13 • up to four years
|
|
Psychiatric disorders
Abnormal dreams
|
5.9%
11/186 • Number of events 11 • up to four years
|
|
Psychiatric disorders
Sleep disorder
|
5.4%
10/186 • Number of events 10 • up to four years
|
|
Vascular disorders
Hypertension
|
5.9%
11/186 • Number of events 11 • up to four years
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER