Trial Outcomes & Findings for Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease (NCT NCT00519532)
NCT ID: NCT00519532
Last Updated: 2014-10-27
Results Overview
The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. Baseline is defined as first titration visit (T1) of SP915.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
84 participants
Primary outcome timeframe
Baseline (baseline SP915) and week 13 (End of maintenance)
Results posted on
2014-10-27
Participant Flow
A total of 84 subjects belong to the Enrolled Set (ES) and all of them received at least 1 dose of trial medication, so they all belong to the Safety Set (SS). 83 subjects belong to the Full Analysis Set (FAS).
Participant Flow information belong to the Enrolled Set (ES). Baseline Characteristics are described for the Full Analysis Set (FAS).
Participant milestones
| Measure |
Rotigotine
Rotigotine Transdermal Patch
|
|---|---|
|
Overall Study
STARTED
|
84
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Rotigotine
Rotigotine Transdermal Patch
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Rotigotine
n=83 Participants
Rotigotine Transdermal Patch
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=93 Participants
|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 10.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=93 Participants
|
|
L- Dopa
Early
|
10 participants
n=93 Participants
|
|
L- Dopa
Advanced
|
73 participants
n=93 Participants
|
|
Body Mass Index (BMI)
|
26.928 kg/ m^2
STANDARD_DEVIATION 4.219 • n=93 Participants
|
|
Height
|
170.1 cm
STANDARD_DEVIATION 10.58 • n=93 Participants
|
|
Weight
|
78.3 kg
STANDARD_DEVIATION 16.6 • n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline (baseline SP915) and week 13 (End of maintenance)Population: Full Analysis Set (FAS).
The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. Baseline is defined as first titration visit (T1) of SP915.
Outcome measures
| Measure |
Rotigotine
n=76 Participants
Rotigotine Transdermal Patch
|
|---|---|
|
Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)
|
-5.8 units on a scale
Standard Deviation 9.4
|
PRIMARY outcome
Timeframe: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)Population: Full Analysis Set (FAS).
The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often. Baseline is defined as Visit 2 of previous double- blind trial SP889.
Outcome measures
| Measure |
Rotigotine
n=78 Participants
Rotigotine Transdermal Patch
|
|---|---|
|
Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)
|
-5.8 units on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)Population: Full Analysis Set (FAS).
Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep. Baseline is defined as Visit 2 of previous double- blind trial SP889.
Outcome measures
| Measure |
Rotigotine
n=79 Participants
Rotigotine Transdermal Patch
|
|---|---|
|
Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)
|
-1.5 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)Population: Full Analysis Set (FAS).
The change in number of nocturias was used to evaluate improvements in sleep disorders. Baseline is defined as Visit 2 of previous double- blind trial SP889.
Outcome measures
| Measure |
Rotigotine
n=78 Participants
Rotigotine Transdermal Patch
|
|---|---|
|
Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)
|
-0.4 Nocturias
Standard Deviation 1.2
|
Adverse Events
Rotigotine
Serious events: 16 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotigotine
n=84 participants at risk
Rotigotine Transdermal Patch
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Cardiac disorders
Atrioventricular block third degree
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
General disorders
Application site vesicles
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
General disorders
Chest pain
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
General disorders
Death
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Infections and infestations
Osteomyelitis
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
3.6%
3/84 • Number of events 3 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Investigations
Eosinophil count increased
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Syncope vasovagal
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Peroneal nerve palsy
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
Other adverse events
| Measure |
Rotigotine
n=84 participants at risk
Rotigotine Transdermal Patch
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
11.9%
10/84 • Number of events 13 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
5/84 • Number of events 6 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
5/84 • Number of events 6 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
General disorders
Application site pruritus
|
9.5%
8/84 • Number of events 10 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
General disorders
Application site erythema
|
11.9%
10/84 • Number of events 12 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
General disorders
Application site irritation
|
6.0%
5/84 • Number of events 6 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
General disorders
Oedema peripheral
|
9.5%
8/84 • Number of events 10 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
7/84 • Number of events 8 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
5/84 • Number of events 6 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Fall
|
11.9%
10/84 • Number of events 11 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
8/84 • Number of events 9 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
6/84 • Number of events 10 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
5/84 • Number of events 6 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Dyskinesia
|
10.7%
9/84 • Number of events 9 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Parkinson´s disease
|
9.5%
8/84 • Number of events 11 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Dizziness
|
10.7%
9/84 • Number of events 11 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Somnolence
|
13.1%
11/84 • Number of events 12 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Headache
|
6.0%
5/84 • Number of events 11 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Psychiatric disorders
Hallucination
|
13.1%
11/84 • Number of events 22 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
|
Psychiatric disorders
Insomnia
|
8.3%
7/84 • Number of events 7 • Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +18778229493
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 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.
- Publication restrictions are in place
Restriction type: OTHER