Trial Outcomes & Findings for Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea (NCT NCT01268891)

Last Updated: 2013-12-03

Results Overview

Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia. The Change From Baseline in Mean Total Daily OFF Time is calculated by taking the difference between the average of the total daily OFF time at Weeks 6, 10, 14 and 18, and the Baseline Total Daily OFF Time.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

132 participants

Primary outcome timeframe

Baseline and Weeks 6, 10, 14, and 18

Results posted on

2013-12-03

Participant Flow

The study consisted of a 2-week Screening Period during which the levodopa dose was optimised (if required), a 2-week Screening Period during which the levodopa dose was stabilised, an 18-week double-blind treatment period with rasagiline or placebo once daily (patients were randomised in a 1:1 ratio), and a 4-week Safety Follow-up Period.

Participant milestones

Participant milestones
Measure	Placebo Once daily; tablet; orally; 18 weeks	Azilect® 1 mg daily; tablet; orally; 18 weeks
Overall Study STARTED	66	66
Overall Study COMPLETED	58	58
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Once daily; tablet; orally; 18 weeks	Azilect® 1 mg daily; tablet; orally; 18 weeks
Overall Study Adverse Event	3	7
Overall Study Lack of Efficacy	1	0
Overall Study Withdrawal of Consent	3	1
Overall Study Administrative or other reason(s)	1	0

Baseline Characteristics

Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=66 Participants Once daily; tablet; orally; 18 weeks	Azilect® n=66 Participants 1 mg daily; tablet; orally; 18 weeks	Total n=132 Participants Total of all reporting groups
Age Continuous	59.5 years STANDARD_DEVIATION 9.0 • n=5 Participants	60.2 years STANDARD_DEVIATION 8.6 • n=7 Participants	59.8 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	33 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	33 Participants n=7 Participants	76 Participants n=5 Participants
Total Daily OFF Time	6.24 hours STANDARD_DEVIATION 2.73 • n=5 Participants	6.26 hours STANDARD_DEVIATION 2.29 • n=7 Participants	6.25 hours STANDARD_DEVIATION 2.50 • n=5 Participants
CGI-S	3.05 units on a scale STANDARD_DEVIATION 0.92 • n=5 Participants	2.94 units on a scale STANDARD_DEVIATION 1.11 • n=7 Participants	2.99 units on a scale STANDARD_DEVIATION 1.02 • n=5 Participants
UPDRS-ADL Score During OFF Time	11.15 units on a scale STANDARD_DEVIATION 5.84 • n=5 Participants	11.79 units on a scale STANDARD_DEVIATION 6.58 • n=7 Participants	11.48 units on a scale STANDARD_DEVIATION 6.21 • n=5 Participants
UPDRS Motor Score During ON time	19.81 units on a scale STANDARD_DEVIATION 8.39 • n=5 Participants	17.98 units on a scale STANDARD_DEVIATION 8.71 • n=7 Participants	18.86 units on a scale STANDARD_DEVIATION 8.57 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Weeks 6, 10, 14, and 18

Population: Full-analysis set (FAS); observed cases (OC)

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Once daily; tablet; orally; 18 weeks	Azilect® n=63 Participants 1 mg daily; tablet; orally; 18 weeks
Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary	-1.24 hours Standard Error 0.26	-1.59 hours Standard Error 0.25

SECONDARY outcome

Timeframe: Week 18

Population: FAS; last observation carried forward (LOCF)

Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Once daily; tablet; orally; 18 weeks	Azilect® n=63 Participants 1 mg daily; tablet; orally; 18 weeks
Clinical Status Using CGI-I Score During ON Time	3.35 units on a scale Standard Error 0.13	3.05 units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: FAS; LOCF

Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Once daily; tablet; orally; 18 weeks	Azilect® n=63 Participants 1 mg daily; tablet; orally; 18 weeks
Change From Baseline in UPDRS-ADL Score During OFF Time	0.13 units on a scale Standard Error 0.42	-0.57 units on a scale Standard Error 0.41

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: FAS; LOCF

UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Once daily; tablet; orally; 18 weeks	Azilect® n=63 Participants 1 mg daily; tablet; orally; 18 weeks
Change From Baseline in UPDRS Motor Score During ON Time	-1.52 units on a scale Standard Error 0.72	-2.87 units on a scale Standard Error 0.69

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Azilect®

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=66 participants at risk	Azilect® n=66 participants at risk
Gastrointestinal disorders Gastritis	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Infections and infestations Pyelonephritis acute	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Injury, poisoning and procedural complications Joint injury	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Injury, poisoning and procedural complications Subdural haemorrhage	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Injury, poisoning and procedural complications Wrist fracture	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline ovarian tumour	0.00% 0/23 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	3.0% 1/33 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Nervous system disorders Loss of consciousness	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Nervous system disorders Subarachnoid haemorrhage	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.

Other adverse events

Other adverse events
Measure	Placebo n=66 participants at risk	Azilect® n=66 participants at risk
Injury, poisoning and procedural complications Accidental overdose	7.6% 5/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	4.5% 3/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Nervous system disorders Dizziness	1.5% 1/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	6.1% 4/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Nervous system disorders Dyskinesia	7.6% 5/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	12.1% 8/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Psychiatric disorders Insomnia	3.0% 2/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	6.1% 4/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.	6.1% 4/66 • Serious Adverse Events: 18-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 18-week double-blind treatment period.

Additional Information

H. Lundbeck A/S

Phone: +45 3630 1311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of this study will be published at the discretion of H. Lundbeck A/S. H. Lundbeck A/S will ensure that the authorship of all publications based on this study is in accordance with the criteria defined by the International Committee of Medical Journal Editors (ICMJE). The primary publication must be published before any secondary publications.
Publication restrictions are in place

Restriction type: OTHER