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Trial Outcomes & Findings for Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon (NCT NCT01568073)

NCT ID: NCT01568073

Last Updated: 2015-09-18

Results Overview

The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period, This results refers when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

600 participants

Primary outcome timeframe

14 to 15 weeks

Results posted on

2015-09-18

Participant Flow

Participant milestones

Participant milestones
Measure
Placebo
Placebo 200 mg
Entacapone
Entacapone - 200 mg
OPC 5mg
OPC, Opicapone 5mg
OPC 25mg
OPC, Opicapone 25mg
OPC 50mg
OPC, Opicapone 50mg
Overall Study
STARTED
121
122
122
119
116
Overall Study
COMPLETED
110
107
110
108
107
Overall Study
NOT COMPLETED
11
15
12
11
9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=121 Participants
Placebo 200 mg
Entacapone
n=122 Participants
Entacapone - 200 mg
OPC 5mg
n=122 Participants
OPC, Opicapone 5mg
OPC 25mg
n=119 Participants
OPC, Opicapone 25mg
OPC 50mg
n=116 Participants
OPC, Opicapone 50mg
Total
n=600 Participants
Total of all reporting groups
Age, Customized
<70 years
80 participants
n=5 Participants
84 participants
n=7 Participants
87 participants
n=5 Participants
81 participants
n=4 Participants
81 participants
n=21 Participants
413 participants
n=8 Participants
Age, Customized
≥70 years
41 participants
n=5 Participants
38 participants
n=7 Participants
35 participants
n=5 Participants
38 participants
n=4 Participants
35 participants
n=21 Participants
187 participants
n=8 Participants
Sex: Female, Male
Female
50 Participants
n=5 Participants
46 Participants
n=7 Participants
51 Participants
n=5 Participants
52 Participants
n=4 Participants
47 Participants
n=21 Participants
246 Participants
n=8 Participants
Sex: Female, Male
Male
71 Participants
n=5 Participants
76 Participants
n=7 Participants
71 Participants
n=5 Participants
67 Participants
n=4 Participants
69 Participants
n=21 Participants
354 Participants
n=8 Participants

PRIMARY outcome

Timeframe: 14 to 15 weeks

The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period, This results refers when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations

Outcome measures

Outcome measures
Measure
Placebo
n=112 Participants
Placebo 200 mg
Entacapone
n=104 Participants
Entacapone - 200 mg
OPC 5mg
n=110 Participants
OPC, Opicapone 5mg
OPC 25mg
n=105 Participants
OPC, Opicapone 25mg
OPC 50mg
n=106 Participants
OPC, Opicapone 50mg
Efficacy of 3 BIA 9-1067 (5 mg, 25 mg, and 50 mg) Compared With 200 mg of Entacapone or Placebo,
-56.0 minutes
Standard Error 13.38
-96.3 minutes
Standard Error 13.40
-91.3 minutes
Standard Error 13.46
-85.9 minutes
Standard Error 13.69
-116.8 minutes
Standard Error 13.97

SECONDARY outcome

Timeframe: 14 to 15 weeks

Total UPDRS (Part I, II (ON) and III) * UPDRS I evaluation of mentation, behavior, and mood * UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food * UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale. Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe The final cumulative score will range from 0 (no disability) to 199 (total disability).

Outcome measures

Outcome measures
Measure
Placebo
n=114 Participants
Placebo 200 mg
Entacapone
n=111 Participants
Entacapone - 200 mg
OPC 5mg
n=113 Participants
OPC, Opicapone 5mg
OPC 25mg
n=111 Participants
OPC, Opicapone 25mg
OPC 50mg
n=109 Participants
OPC, Opicapone 50mg
Total UPDRS SCORE (I, II (ON), and III)
Change from Baseline to Endpoint
-5.6 units on a scale
Standard Deviation 10.03
-6.0 units on a scale
Standard Deviation 11.69
-7.6 units on a scale
Standard Deviation 9.96
-7.6 units on a scale
Standard Deviation 9.76
-6.5 units on a scale
Standard Deviation 10.14
Total UPDRS SCORE (I, II (ON), and III)
Baseline (Day 0)
37.6 units on a scale
Standard Deviation 16.56
35.4 units on a scale
Standard Deviation 19.98
38.2 units on a scale
Standard Deviation 16.16
40.1 units on a scale
Standard Deviation 18.56
38.8 units on a scale
Standard Deviation 18.99
Total UPDRS SCORE (I, II (ON), and III)
Endpoint (14 to 15 weeks)
32.1 units on a scale
Standard Deviation 14.87
29.8 units on a scale
Standard Deviation 18.69
31.0 units on a scale
Standard Deviation 15.98
32.0 units on a scale
Standard Deviation 15.61
31.5 units on a scale
Standard Deviation 18.72

SECONDARY outcome

Timeframe: 14 to 15 weeks

The Parkinson's disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing. Subscale has 0-10 ratings, where 0 = severe and 10 = normal The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability.

Outcome measures

Outcome measures
Measure
Placebo
n=112 Participants
Placebo 200 mg
Entacapone
n=111 Participants
Entacapone - 200 mg
OPC 5mg
n=111 Participants
OPC, Opicapone 5mg
OPC 25mg
n=110 Participants
OPC, Opicapone 25mg
OPC 50mg
n=108 Participants
OPC, Opicapone 50mg
Parkinson's Disease Sleep Scale (PDSS)
Baseline
97.5 units on a scale
Standard Deviation 24.97
100.7 units on a scale
Standard Deviation 25.46
97.8 units on a scale
Standard Deviation 22.55
92.7 units on a scale
Standard Deviation 26.85
98.0 units on a scale
Standard Deviation 22.19
Parkinson's Disease Sleep Scale (PDSS)
Visit 5
97.6 units on a scale
Standard Deviation 24.20
102.5 units on a scale
Standard Deviation 26.20
103.8 units on a scale
Standard Deviation 22.08
101.7 units on a scale
Standard Deviation 23.92
100.2 units on a scale
Standard Deviation 24.37
Parkinson's Disease Sleep Scale (PDSS)
Visit 7
97.7 units on a scale
Standard Deviation 25.30
103.2 units on a scale
Standard Deviation 24.86
102.8 units on a scale
Standard Deviation 22.78
100.6 units on a scale
Standard Deviation 23.75
100.7 units on a scale
Standard Deviation 24.20
Parkinson's Disease Sleep Scale (PDSS)
Endpoint (14 to 15 weeks)
98.5 units on a scale
Standard Deviation 25.81
102.8 units on a scale
Standard Deviation 24.98
102.9 units on a scale
Standard Deviation 22.61
100.4 units on a scale
Standard Deviation 23.75
100.9 units on a scale
Standard Deviation 24.05

SECONDARY outcome

Timeframe: 14 to 15 weeks

The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3 Frequency Rarely (\<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4 The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency\*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores. The NMSS total score is calculated by adding all domain scores (0-360), and lower scores mean less disability.

Outcome measures

Outcome measures
Measure
Placebo
n=118 Participants
Placebo 200 mg
Entacapone
n=119 Participants
Entacapone - 200 mg
OPC 5mg
n=117 Participants
OPC, Opicapone 5mg
OPC 25mg
n=115 Participants
OPC, Opicapone 25mg
OPC 50mg
n=114 Participants
OPC, Opicapone 50mg
Non-motor Symptoms Scale (NMSS)
Baseline
38.8 units on a scale
Standard Deviation 29.20
32.1 units on a scale
Standard Deviation 25.09
36.1 units on a scale
Standard Deviation 26.67
39.8 units on a scale
Standard Deviation 30.18
36.4 units on a scale
Standard Deviation 28.02
Non-motor Symptoms Scale (NMSS)
Visit 5
33.4 units on a scale
Standard Deviation 27.91
27.9 units on a scale
Standard Deviation 21.53
30.2 units on a scale
Standard Deviation 24.36
34.0 units on a scale
Standard Deviation 24.83
30.2 units on a scale
Standard Deviation 21.56
Non-motor Symptoms Scale (NMSS)
Visit 7
32.3 units on a scale
Standard Deviation 25.75
27.5 units on a scale
Standard Deviation 21.91
29.5 units on a scale
Standard Deviation 24.30
34.6 units on a scale
Standard Deviation 25.39
33.7 units on a scale
Standard Deviation 30.24
Non-motor Symptoms Scale (NMSS)
Endpoint
32.0 units on a scale
Standard Deviation 25.71
27.5 units on a scale
Standard Deviation 21.82
29.5 units on a scale
Standard Deviation 24.30
34.4 units on a scale
Standard Deviation 25.32
33.4 units on a scale
Standard Deviation 30.23

Adverse Events

Placebo

Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths

Entacapone

Serious events: 8 serious events
Other events: 55 other events
Deaths: 0 deaths

OPC 5mg

Serious events: 4 serious events
Other events: 48 other events
Deaths: 0 deaths

OPC 25mg

Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths

OPC 50mg

Serious events: 4 serious events
Other events: 55 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo
n=121 participants at risk
Placebo 200 mg
Entacapone
n=122 participants at risk
Entacapone - 200 mg
OPC 5mg
n=122 participants at risk
OPC, Opicapone 5mg
OPC 25mg
n=119 participants at risk
OPC, Opicapone 25mg
OPC 50mg
n=115 participants at risk
OPC, Opicapone 50mg
Cardiac disorders
ANGINA UNSTABLE
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.87%
1/115
Cardiac disorders
COR PULMONALE ACUTE
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Cardiac disorders
CORONARY ARTERY DISEASE
0.00%
0/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.87%
1/115
Eye disorders
VISUAL IMPAIRMENT
0.83%
1/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Gastrointestinal disorders
CONSTIPATION
0.00%
0/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.87%
1/115
Gastrointestinal disorders
DUODENITIS
0.83%
1/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Gastrointestinal disorders
GASTRITIS
0.83%
1/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Gastrointestinal disorders
INGUINAL HERNIA
0.00%
0/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.87%
1/115
Gastrointestinal disorders
PANCREATITIS ACUTE
0.83%
1/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Hepatobiliary disorders
CHOLELITHIASIS
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Hepatobiliary disorders
HEPATITIS ACUTE
0.83%
1/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Infections and infestations
CHOLECYSTITIS INFECTIVE
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Infections and infestations
ERYSIPELAS
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Injury, poisoning and procedural complications
CONTUSION
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Injury, poisoning and procedural complications
FALL
0.00%
0/121
1.6%
2/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Injury, poisoning and procedural complications
FEMUR FRACTURE
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Injury, poisoning and procedural complications
NEAR DROWNING
0.83%
1/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Injury, poisoning and procedural complications
WRIST FRACTURE
0.00%
0/121
0.00%
0/122
0.82%
1/122
0.00%
0/119
0.00%
0/115
Investigations
HEPATIC ENZYME INCREASED
0.83%
1/121
0.00%
0/122
0.82%
1/122
0.00%
0/119
0.00%
0/115
Musculoskeletal and connective tissue disorders
BACK PAIN
0.83%
1/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
0.00%
0/121
0.00%
0/122
0.82%
1/122
0.00%
0/119
0.00%
0/115
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
0.00%
0/121
0.00%
0/122
0.82%
1/122
0.00%
0/119
0.00%
0/115
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN EAR NEOPLASM
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BOWEN'S DISEASE
0.00%
0/121
0.00%
0/122
0.00%
0/122
0.84%
1/119
0.00%
0/115
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SUPERFICIAL SPREADING MELANOMA STAGE
0.83%
1/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Nervous system disorders
DYSKINESIA
0.00%
0/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.87%
1/115
Nervous system disorders
SYNCOPE
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Renal and urinary disorders
URINARY TRACT INFLAMMATION
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
0.83%
1/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Vascular disorders
HYPERTENSION
0.83%
1/121
0.00%
0/122
0.00%
0/122
0.00%
0/119
0.00%
0/115
Vascular disorders
ORTHOSTATIC HYPOTENSION
0.00%
0/121
0.82%
1/122
0.00%
0/122
0.00%
0/119
0.00%
0/115

Other adverse events

Other adverse events
Measure
Placebo
n=121 participants at risk
Placebo 200 mg
Entacapone
n=122 participants at risk
Entacapone - 200 mg
OPC 5mg
n=122 participants at risk
OPC, Opicapone 5mg
OPC 25mg
n=119 participants at risk
OPC, Opicapone 25mg
OPC 50mg
n=115 participants at risk
OPC, Opicapone 50mg
Nervous system disorders
DYSKINESIA
4.1%
5/121
8.2%
10/122
13.9%
17/122
7.6%
9/119
15.7%
18/115
Psychiatric disorders
INSOMNIA
0.83%
1/121
5.7%
7/122
1.6%
2/122
5.9%
7/119
6.1%
7/115
Gastrointestinal disorders
CONSTIPATION
2.5%
3/121
4.1%
5/122
3.3%
4/122
0.00%
0/119
6.1%
7/115
Nervous system disorders
DIZZINESS
0.83%
1/121
4.1%
5/122
1.6%
2/122
5.0%
6/119
2.6%
3/115
Psychiatric disorders
HALLUCINATION
0.83%
1/121
0.82%
1/122
0.82%
1/122
5.0%
6/119
0.87%
1/115
Vascular disorders
HYPERTENSION
2.5%
3/121
1.6%
2/122
3.3%
4/122
1.7%
2/119
1.7%
2/115
Gastrointestinal disorders
NAUSEA
1.7%
2/121
6.6%
8/122
1.6%
2/122
2.5%
3/119
2.6%
3/115
Musculoskeletal and connective tissue disorders
BACK PAIN
5.0%
6/121
0.82%
1/122
3.3%
4/122
2.5%
3/119
0.00%
0/115
Injury, poisoning and procedural complications
FALL
2.5%
3/121
4.1%
5/122
1.6%
2/122
3.4%
4/119
0.87%
1/115
Nervous system disorders
HEADACHE
2.5%
3/121
2.5%
3/122
0.82%
1/122
1.7%
2/119
3.5%
4/115
Respiratory, thoracic and mediastinal disorders
NASOPHARYNGITIS
3.3%
4/121
1.6%
2/122
3.3%
4/122
1.7%
2/119
0.87%
1/115
Nervous system disorders
SOMNOLENCE
1.7%
2/121
0.00%
0/122
0.82%
1/122
3.4%
4/119
1.7%
2/115
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
0.83%
1/121
0.82%
1/122
0.82%
1/122
3.4%
4/119
0.87%
1/115
Psychiatric disorders
ANXIETY
3.3%
4/121
1.6%
2/122
0.82%
1/122
1.7%
2/119
1.7%
2/115
Investigations
WEIGHT DECREASED
0.00%
0/121
1.6%
2/122
0.82%
1/122
0.00%
0/119
3.5%
4/115
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
3.3%
4/121
0.82%
1/122
0.82%
1/122
1.7%
2/119
0.00%
0/115

Additional Information

Head of Clinical Research

Bial - Portela & Cª, S.A.

Phone: +351 229 866 100

Results disclosure agreements

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

Restriction type: OTHER