Trial Outcomes & Findings for A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients (NCT NCT01631812)

NCT ID: NCT01631812

Last Updated: 2014-03-19

Results Overview

Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing. \*decrease in difference between supine and standing systolic blood pressure

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 130 participants
• Primary outcome timeframe: Up to 55 weeks after dosing
• Results posted on: 2014-03-19

Participant Flow

Participant milestones

Measure	SPM 962 SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
Overall Study STARTED	130
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Measure	SPM 962 SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
Overall Study Adverse Event	25
Overall Study Lack of Efficacy	5
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	3

Baseline Characteristics

A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients

Baseline characteristics by cohort

Measure	SPM 962 n=130 Participants SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	96 Participants n=5 Participants
Age, Continuous	66.9 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants
Region of Enrollment Japan	130 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 55 weeks after dosing

Population: Safety set (SS)

Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing.

*decrease in difference between supine and standing systolic blood pressure

Outcome measures

Measure	SPM 962 n=130 Participants SPM 962 transdermal patch once a daily up to 36.0 mg/day
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. Any AEs	126 participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. Treatment-Related AEs	112 participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. SAEs including death	17 participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. Severe AEs	12 participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. Discontinuation due to AEs	26 participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. Severe laboratory abnormality	10 participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. ≥30 mmHg decrease*	6 participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. Treatment-related AE of orthostatic hypotension	6 participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. QTcB ≥500 ms	1 participants

PRIMARY outcome

Timeframe: Up to 55 weeks after dosing

Population: SS

Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.

-: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum

Outcome measures

Measure	SPM 962 n=130 Participants SPM 962 transdermal patch once a daily up to 36.0 mg/day
Skin Irritation Score of the Application Site -	18 participants
Skin Irritation Score of the Application Site ±	53 participants
Skin Irritation Score of the Application Site +	42 participants
Skin Irritation Score of the Application Site ++	9 participants
Skin Irritation Score of the Application Site +++	7 participants
Skin Irritation Score of the Application Site ++++	1 participants
Skin Irritation Score of the Application Site +++>	8 participants

SECONDARY outcome

Timeframe: Baseline, Up to 54 weeks after dosing

Population: Full analysis set (FAS), last observation carried forward (LOCF)

Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) up to 54 weeks after dosing UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.

Outcome measures

Measure	SPM 962 n=129 Participants SPM 962 transdermal patch once a daily up to 36.0 mg/day
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score Week 12	-9.6 Scores on a scale Standard Deviation 8.1
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score Week 24	-9.1 Scores on a scale Standard Deviation 8.2
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score Week 52	-8.3 Scores on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: Baseline, Up to 54 weeks after dosing

Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) up to 54 weeks after dosing UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.

Outcome measures

Measure	SPM 962 n=129 Participants SPM 962 transdermal patch once a daily up to 36.0 mg/day
UPDRS Part 2 Sum Score Week 12	-2.7 Scores on a scale Standard Deviation 3.5
UPDRS Part 2 Sum Score Week 24	-2.4 Scores on a scale Standard Deviation 3.7
UPDRS Part 2 Sum Score Week 52	-1.9 Scores on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: Up to 54 weeks after dosing

Population: FAS subjects with "off state" at baseline

Mean number of hours in "off state" during a 24-hour period.

Outcome measures

Measure	SPM 962 n=84 Participants SPM 962 transdermal patch once a daily up to 36.0 mg/day
Absolute Time Spent "Off" Week 12	-3.0 Hours Standard Deviation 2.7
Absolute Time Spent "Off" Week 24	-2.6 Hours Standard Deviation 2.9
Absolute Time Spent "Off" Week 52	-1.9 Hours Standard Deviation 3.0

Adverse Events

SPM 962

Serious events: 17 serious events

Other events: 119 other events

Deaths: 0 deaths

Serious adverse events

Measure	SPM 962 n=130 participants at risk SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
Gastrointestinal disorders Colonic Polyp	0.77% 1/130 • Number of events 1 • 54 weeks
General disorders Sudden Death	0.77% 1/130 • Number of events 1 • 54 weeks
Hepatobiliary disorders Bile Duct Stone	0.77% 1/130 • Number of events 1 • 54 weeks
Infections and infestations Atypical Mycobacterial Infection	0.77% 1/130 • Number of events 1 • 54 weeks
Infections and infestations Herpes Zoster	0.77% 1/130 • Number of events 1 • 54 weeks
Infections and infestations Pneumonia	1.5% 2/130 • Number of events 2 • 54 weeks
Injury, poisoning and procedural complications Femoral Neck Fracture	1.5% 2/130 • Number of events 2 • 54 weeks
Injury, poisoning and procedural complications Pelvic Fracture	0.77% 1/130 • Number of events 1 • 54 weeks
Investigations Weight Decreased	0.77% 1/130 • Number of events 1 • 54 weeks
Metabolism and nutrition disorders Dehydration	0.77% 1/130 • Number of events 1 • 54 weeks
Metabolism and nutrition disorders Diabetes Mellitus	0.77% 1/130 • Number of events 1 • 54 weeks
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.77% 1/130 • Number of events 1 • 54 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma Kidney	0.77% 1/130 • Number of events 1 • 54 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large Intestine Carcinoma	0.77% 1/130 • Number of events 1 • 54 weeks
Psychiatric disorders Delusion	1.5% 2/130 • Number of events 2 • 54 weeks
Psychiatric disorders Hallucination	0.77% 1/130 • Number of events 1 • 54 weeks
Psychiatric disorders Hallucination, Auditory	0.77% 1/130 • Number of events 1 • 54 weeks
Renal and urinary disorders Nephrolithiasis	0.77% 1/130 • Number of events 1 • 54 weeks

Other adverse events

Measure	SPM 962 n=130 participants at risk SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
Blood and lymphatic system disorders Anaemia	3.8% 5/130 • Number of events 5 • 54 weeks
Gastrointestinal disorders Nausea	13.1% 17/130 • Number of events 24 • 54 weeks
Gastrointestinal disorders Constipation	10.0% 13/130 • Number of events 13 • 54 weeks
Gastrointestinal disorders Vomiting	8.5% 11/130 • Number of events 13 • 54 weeks
Gastrointestinal disorders Diarrhoea	4.6% 6/130 • Number of events 6 • 54 weeks
Gastrointestinal disorders Toothache	3.1% 4/130 • Number of events 5 • 54 weeks
General disorders Application Site Reaction	51.5% 67/130 • Number of events 69 • 54 weeks
General disorders Oedema Peripheral	6.2% 8/130 • Number of events 8 • 54 weeks
General disorders Application Site Erythema	3.1% 4/130 • Number of events 5 • 54 weeks
General disorders Feeling Abnormal	3.1% 4/130 • Number of events 5 • 54 weeks
Infections and infestations Nasopharyngitis	20.8% 27/130 • Number of events 37 • 54 weeks
Infections and infestations Cystitis	3.1% 4/130 • Number of events 4 • 54 weeks
Infections and infestations Tinea Infection	3.1% 4/130 • Number of events 4 • 54 weeks
Injury, poisoning and procedural complications Contusion	11.5% 15/130 • Number of events 19 • 54 weeks
Injury, poisoning and procedural complications Fall	7.7% 10/130 • Number of events 14 • 54 weeks
Injury, poisoning and procedural complications Excoriation	3.1% 4/130 • Number of events 4 • 54 weeks
Injury, poisoning and procedural complications Tooth Fracture	3.1% 4/130 • Number of events 4 • 54 weeks
Investigations Blood Creatine Phosphokinase Increased	6.2% 8/130 • Number of events 11 • 54 weeks
Investigations Weight Decreased	3.8% 5/130 • Number of events 5 • 54 weeks
Metabolism and nutrition disorders Decreased Appetite	3.1% 4/130 • Number of events 5 • 54 weeks
Musculoskeletal and connective tissue disorders Back Pain	10.0% 13/130 • Number of events 16 • 54 weeks
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 4/130 • Number of events 5 • 54 weeks
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	3.1% 4/130 • Number of events 4 • 54 weeks
Musculoskeletal and connective tissue disorders Osteoarthritis	3.1% 4/130 • Number of events 4 • 54 weeks
Nervous system disorders Dyskinesia	16.2% 21/130 • Number of events 24 • 54 weeks
Nervous system disorders Dizziness	7.7% 10/130 • Number of events 13 • 54 weeks
Nervous system disorders Headache	5.4% 7/130 • Number of events 7 • 54 weeks
Nervous system disorders Dystonia	3.8% 5/130 • Number of events 6 • 54 weeks
Nervous system disorders Dizziness Postural	3.1% 4/130 • Number of events 6 • 54 weeks
Psychiatric disorders Hallucination Visual	15.4% 20/130 • Number of events 28 • 54 weeks
Psychiatric disorders Somnolence	14.6% 19/130 • Number of events 20 • 54 weeks
Psychiatric disorders Insomnia	6.2% 8/130 • Number of events 8 • 54 weeks
Psychiatric disorders Hallucination	3.8% 5/130 • Number of events 5 • 54 weeks
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Inflammation	7.7% 10/130 • Number of events 12 • 54 weeks
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	3.1% 4/130 • Number of events 4 • 54 weeks
Skin and subcutaneous tissue disorders Eczema	3.1% 4/130 • Number of events 4 • 54 weeks
Skin and subcutaneous tissue disorders Rash	3.1% 4/130 • Number of events 5 • 54 weeks
Vascular disorders Orthostatic Hypotension	5.4% 7/130 • Number of events 8 • 54 weeks

Additional Information

Director of Clinical Research and Development

Otsuka Pharmaceutical Co., Ltd.

Phone: +81-3-6361-7366

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place