Trial Outcomes & Findings for Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients (NCT NCT01646268)

Results Overview

The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. The sum score ranges from 0 to 160, higher scores denote greater disability.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

249 participants

Primary outcome timeframe

From Baseline (Week 0) to end of Maintenance Period (up to Week 24)

Results posted on

2015-08-11

Participant Flow

The SP0914 study began recruitment in July 2012 and concluded in May 2014. All subjects were recruited in China.

The Participant Flow and Demographics data is taken from the Randomized Set (RS). The RS includes all subjects that were randomized.

Participant milestones

Participant milestones
Measure	Rotigotine Rotigotine, daily doses, treatment group Rotigotine: Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.	Placebo Placebo, daily doses, placebo group Placebo Patch: Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches.
Overall Study STARTED	124	123
Overall Study COMPLETED	113	107
Overall Study NOT COMPLETED	11	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Rotigotine Rotigotine, daily doses, treatment group Rotigotine: Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.	Placebo Placebo, daily doses, placebo group Placebo Patch: Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches.
Overall Study Adverse Event	6	7
Overall Study Lack of Efficacy	1	3
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	2	5
Overall Study Other	2	0

Baseline Characteristics

Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rotigotine n=124 Participants Rotigotine, daily doses, treatment group Rotigotine: Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.	Placebo n=123 Participants Placebo, daily doses, placebo group Placebo Patch: Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches.	Total n=247 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	88 Participants n=5 Participants	82 Participants n=7 Participants	170 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants
Age, Continuous	59.1 years STANDARD_DEVIATION 10.3 • n=5 Participants	59.7 years STANDARD_DEVIATION 10.1 • n=7 Participants	59.4 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	47 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	76 Participants n=7 Participants	150 Participants n=5 Participants
Region of Enrollment China	124 participants n=5 Participants	123 participants n=7 Participants	247 participants n=5 Participants
Weight	63.2 kilograms STANDARD_DEVIATION 10.5 • n=5 Participants	64.0 kilograms STANDARD_DEVIATION 9.9 • n=7 Participants	63.6 kilograms STANDARD_DEVIATION 10.2 • n=5 Participants

PRIMARY outcome

Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)

Population: This analysis consists of the Full Analysis Set \[Last Observation Carried Forward\], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.

The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. The sum score ranges from 0 to 160, higher scores denote greater disability.

Outcome measures

Outcome measures
Measure	Rotigotine n=123 Participants Rotigotine, daily doses, treatment group Rotigotine: Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.	Placebo n=121 Participants Placebo, daily doses, placebo group Placebo Patch: Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches.
Change in the Sum of the Score From the Activities of Daily Living (ADL) Scale and Motor Examination in the Unified Parkinson's Disease Rating Scale (UPDRS) (Parts II+III, a UPDRS Subtotal) From Baseline to the End of Double-blind Maintenance Period	-4.9 units on a scale Standard Deviation 9.9	-0.2 units on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)

Population: This analysis consists of the Full Analysis Set \[Last Observation Carried Forward\], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.

The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. A higher score denotes greater disability.

Outcome measures

Outcome measures
Measure	Rotigotine n=123 Participants Rotigotine, daily doses, treatment group Rotigotine: Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.	Placebo n=121 Participants Placebo, daily doses, placebo group Placebo Patch: Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches.
Response to Therapy, Defined as ≥20 % Decrease in the Sum of Scores From Activities of Daily Living (ADL) & Motor Examination in Unified Parkinson's Disease Rating Scale (UPDRS Parts II+III, a UPDRS Subtotal) From Baseline to End of Maintenance Period	42.3 percentage of responders	22.3 percentage of responders

SECONDARY outcome

Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)

Population: This analysis consists of the Full Analysis Set \[Last Observation Carried Forward\], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.

The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score ranges from 0 to 52, higher scores denote greater disability.

Outcome measures

Outcome measures
Measure	Rotigotine n=123 Participants Rotigotine, daily doses, treatment group Rotigotine: Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.	Placebo n=121 Participants Placebo, daily doses, placebo group Placebo Patch: Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches.
Change in Unified Parkinson's Disease Rating Scale [UPDRS Part II (ADL)] From Baseline to the End of the Double-blind Maintenance Period	-1.4 units on a scale Standard Deviation 3.6	0.1 units on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)

Population: This analysis consists of the Full Analysis Set \[Last Observation Carried Forward\], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.

The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score ranges from 0 to 108, higher scores denote greater disability.

Outcome measures

Outcome measures
Measure	Rotigotine n=123 Participants Rotigotine, daily doses, treatment group Rotigotine: Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.	Placebo n=121 Participants Placebo, daily doses, placebo group Placebo Patch: Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches.
Change in Unified Parkinson's Disease Rating Scale [UPDRS Part III (Motor Examination)] From Baseline to the End of the Double-blind Maintenance Period	-3.4 units on a scale Standard Deviation 7.3	-0.3 units on a scale Standard Deviation 7.4

Adverse Events

Rotigotine

Serious events: 6 serious events

Other events: 35 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rotigotine n=124 participants at risk Rotigotine, daily doses, treatment group Rotigotine: Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.	Placebo n=123 participants at risk Placebo, daily doses, placebo group Placebo Patch: Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches.
Cardiac disorders Coronary artery disease	0.00% 0/124 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	0.81% 1/123 • Number of events 1 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Cardiac disorders Atrial fibrillation	0.81% 1/124 • Number of events 1 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	0.00% 0/123 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Congenital, familial and genetic disorders Myocardial bridging	0.81% 1/124 • Number of events 1 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	0.00% 0/123 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Gastrointestinal disorders Gastric polyps	0.81% 1/124 • Number of events 1 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	0.00% 0/123 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Gastrointestinal disorders Large intestine polyp	0.81% 1/124 • Number of events 1 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	0.00% 0/123 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.81% 1/124 • Number of events 1 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	0.00% 0/123 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.81% 1/124 • Number of events 1 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	0.00% 0/123 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Nervous system disorders Transient ischaemic attack	0.81% 1/124 • Number of events 1 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	0.00% 0/123 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).

Other adverse events

Other adverse events
Measure	Rotigotine n=124 participants at risk Rotigotine, daily doses, treatment group Rotigotine: Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.	Placebo n=123 participants at risk Placebo, daily doses, placebo group Placebo Patch: Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches.
Gastrointestinal disorders Nausea	8.9% 11/124 • Number of events 16 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	3.3% 4/123 • Number of events 4 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Gastrointestinal disorders Vomiting	5.6% 7/124 • Number of events 9 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	1.6% 2/123 • Number of events 2 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Nervous system disorders Somnolence	8.1% 10/124 • Number of events 10 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	3.3% 4/123 • Number of events 4 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Nervous system disorders Dizziness	8.1% 10/124 • Number of events 13 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	5.7% 7/123 • Number of events 9 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Skin and subcutaneous tissue disorders Erythema	6.5% 8/124 • Number of events 11 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	1.6% 2/123 • Number of events 2 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).
Skin and subcutaneous tissue disorders Pruritus	8.1% 10/124 • Number of events 12 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).	4.1% 5/123 • Number of events 5 • Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. AE and SAE data represents Treatment-emergent Adverse Events (TEAE).

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee UCB has \> 60 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 the results shall be published regardless of outcome.
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