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Trial record 16 of 18 for:    "Basal Ganglia Disease" | "Benserazide"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01568073
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : January 8, 2015
Last Update Posted : September 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: BIA 9-1067
Drug: Entacapone
Drug: Placebo
Drug: Levodopa
Drug: Carbidopa
Drug: Benserazide
Enrollment 600
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Entacapone OPC 5mg OPC 25mg OPC 50mg
Hide Arm/Group Description Placebo 200 mg Entacapone - 200 mg OPC, Opicapone 5mg OPC, Opicapone 25mg OPC, Opicapone 50mg
Period Title: Overall Study
Started 121 122 122 119 116
Completed 110 107 110 108 107
Not Completed 11 15 12 11 9
Arm/Group Title Placebo Entacapone OPC 5mg OPC 25mg OPC 50mg Total
Hide Arm/Group Description Placebo 200 mg Entacapone - 200 mg OPC, Opicapone 5mg OPC, Opicapone 25mg OPC, Opicapone 50mg Total of all reporting groups
Overall Number of Baseline Participants 121 122 122 119 116 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants 122 participants 122 participants 119 participants 116 participants 600 participants
<70 years 80 84 87 81 81 413
≥70 years 41 38 35 38 35 187
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 122 participants 122 participants 119 participants 116 participants 600 participants
Female
50
  41.3%
46
  37.7%
51
  41.8%
52
  43.7%
47
  40.5%
246
  41.0%
Male
71
  58.7%
76
  62.3%
71
  58.2%
67
  56.3%
69
  59.5%
354
  59.0%
1.Primary Outcome
Title Efficacy of 3 BIA 9-1067 (5 mg, 25 mg, and 50 mg) Compared With 200 mg of Entacapone or Placebo,
Hide Description 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
Time Frame 14 to 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Entacapone OPC 5mg OPC 25mg OPC 50mg
Hide Arm/Group Description:
Placebo 200 mg
Entacapone - 200 mg
OPC, Opicapone 5mg
OPC, Opicapone 25mg
OPC, Opicapone 50mg
Overall Number of Participants Analyzed 112 104 110 105 106
Mean (Standard Error)
Unit of Measure: minutes
-56.0  (13.38) -96.3  (13.40) -91.3  (13.46) -85.9  (13.69) -116.8  (13.97)
2.Secondary Outcome
Title Total UPDRS SCORE (I, II (ON), and III)
Hide Description

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).

Time Frame 14 to 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Entacapone OPC 5mg OPC 25mg OPC 50mg
Hide Arm/Group Description:
Placebo 200 mg
Entacapone - 200 mg
OPC, Opicapone 5mg
OPC, Opicapone 25mg
OPC, Opicapone 50mg
Overall Number of Participants Analyzed 114 111 113 111 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (Day 0) 37.6  (16.56) 35.4  (19.98) 38.2  (16.16) 40.1  (18.56) 38.8  (18.99)
Endpoint (14 to 15 weeks) 32.1  (14.87) 29.8  (18.69) 31.0  (15.98) 32.0  (15.61) 31.5  (18.72)
Change from Baseline to Endpoint -5.6  (10.03) -6.0  (11.69) -7.6  (9.96) -7.6  (9.76) -6.5  (10.14)
3.Secondary Outcome
Title Parkinson's Disease Sleep Scale (PDSS)
Hide Description

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.

Time Frame 14 to 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Entacapone OPC 5mg OPC 25mg OPC 50mg
Hide Arm/Group Description:
Placebo 200 mg
Entacapone - 200 mg
OPC, Opicapone 5mg
OPC, Opicapone 25mg
OPC, Opicapone 50mg
Overall Number of Participants Analyzed 112 111 111 110 108
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 97.5  (24.97) 100.7  (25.46) 97.8  (22.55) 92.7  (26.85) 98.0  (22.19)
Visit 5 97.6  (24.20) 102.5  (26.20) 103.8  (22.08) 101.7  (23.92) 100.2  (24.37)
Visit 7 97.7  (25.30) 103.2  (24.86) 102.8  (22.78) 100.6  (23.75) 100.7  (24.20)
Endpoint (14 to 15 weeks) 98.5  (25.81) 102.8  (24.98) 102.9  (22.61) 100.4  (23.75) 100.9  (24.05)
4.Secondary Outcome
Title Non-motor Symptoms Scale (NMSS)
Hide Description

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.

Time Frame 14 to 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Entacapone OPC 5mg OPC 25mg OPC 50mg
Hide Arm/Group Description:
Placebo 200 mg
Entacapone - 200 mg
OPC, Opicapone 5mg
OPC, Opicapone 25mg
OPC, Opicapone 50mg
Overall Number of Participants Analyzed 118 119 117 115 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 38.8  (29.20) 32.1  (25.09) 36.1  (26.67) 39.8  (30.18) 36.4  (28.02)
Visit 5 33.4  (27.91) 27.9  (21.53) 30.2  (24.36) 34.0  (24.83) 30.2  (21.56)
Visit 7 32.3  (25.75) 27.5  (21.91) 29.5  (24.30) 34.6  (25.39) 33.7  (30.24)
Endpoint 32.0  (25.71) 27.5  (21.82) 29.5  (24.30) 34.4  (25.32) 33.4  (30.23)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Entacapone OPC 5mg OPC 25mg OPC 50mg
Hide Arm/Group Description Placebo 200 mg Entacapone - 200 mg OPC, Opicapone 5mg OPC, Opicapone 25mg OPC, Opicapone 50mg
All-Cause Mortality
Placebo Entacapone OPC 5mg OPC 25mg OPC 50mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Entacapone OPC 5mg OPC 25mg OPC 50mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/121 (4.96%)   8/122 (6.56%)   4/122 (3.28%)   1/119 (0.84%)   4/115 (3.48%) 
Cardiac disorders           
ANGINA UNSTABLE  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  1/115 (0.87%) 
COR PULMONALE ACUTE  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
CORONARY ARTERY DISEASE  1  0/121 (0.00%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  1/115 (0.87%) 
Eye disorders           
VISUAL IMPAIRMENT  1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
Gastrointestinal disorders           
CONSTIPATION  1  0/121 (0.00%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  1/115 (0.87%) 
DUODENITIS  1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
GASTRITIS  1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
INGUINAL HERNIA  1  0/121 (0.00%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  1/115 (0.87%) 
PANCREATITIS ACUTE  1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
Hepatobiliary disorders           
CHOLELITHIASIS  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
HEPATITIS ACUTE  1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
Infections and infestations           
CHOLECYSTITIS INFECTIVE  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
ERYSIPELAS  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
Injury, poisoning and procedural complications           
CONTUSION  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
FALL  1  0/121 (0.00%)  2/122 (1.64%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
FEMUR FRACTURE  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
NEAR DROWNING  1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
WRIST FRACTURE  1  0/121 (0.00%)  0/122 (0.00%)  1/122 (0.82%)  0/119 (0.00%)  0/115 (0.00%) 
Investigations           
HEPATIC ENZYME INCREASED  1  1/121 (0.83%)  0/122 (0.00%)  1/122 (0.82%)  0/119 (0.00%)  0/115 (0.00%) 
Musculoskeletal and connective tissue disorders           
BACK PAIN  1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
PAIN IN EXTREMITY  1  0/121 (0.00%)  0/122 (0.00%)  1/122 (0.82%)  0/119 (0.00%)  0/115 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
BASAL CELL CARCINOMA  1  0/121 (0.00%)  0/122 (0.00%)  1/122 (0.82%)  0/119 (0.00%)  0/115 (0.00%) 
BENIGN EAR NEOPLASM  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
BOWEN'S DISEASE  1  0/121 (0.00%)  0/122 (0.00%)  0/122 (0.00%)  1/119 (0.84%)  0/115 (0.00%) 
SUPERFICIAL SPREADING MELANOMA STAGE  1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
Nervous system disorders           
DYSKINESIA  1  0/121 (0.00%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  1/115 (0.87%) 
SYNCOPE  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
Renal and urinary disorders           
URINARY TRACT INFLAMMATION  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
PNEUMONIA ASPIRATION  1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
PULMONARY EMBOLISM  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
Vascular disorders           
HYPERTENSION  1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
ORTHOSTATIC HYPOTENSION  1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/119 (0.00%)  0/115 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo Entacapone OPC 5mg OPC 25mg OPC 50mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/121 (35.54%)   55/122 (45.08%)   48/122 (39.34%)   50/119 (42.02%)   55/115 (47.83%) 
Gastrointestinal disorders           
CONSTIPATION  1  3/121 (2.48%)  5/122 (4.10%)  4/122 (3.28%)  0/119 (0.00%)  7/115 (6.09%) 
NAUSEA  1  2/121 (1.65%)  8/122 (6.56%)  2/122 (1.64%)  3/119 (2.52%)  3/115 (2.61%) 
Injury, poisoning and procedural complications           
FALL  1  3/121 (2.48%)  5/122 (4.10%)  2/122 (1.64%)  4/119 (3.36%)  1/115 (0.87%) 
Investigations           
WEIGHT DECREASED  1  0/121 (0.00%)  2/122 (1.64%)  1/122 (0.82%)  0/119 (0.00%)  4/115 (3.48%) 
Musculoskeletal and connective tissue disorders           
BACK PAIN  1  6/121 (4.96%)  1/122 (0.82%)  4/122 (3.28%)  3/119 (2.52%)  0/115 (0.00%) 
MUSCLE SPASMS  1  1/121 (0.83%)  1/122 (0.82%)  1/122 (0.82%)  4/119 (3.36%)  1/115 (0.87%) 
Nervous system disorders           
DYSKINESIA  1  5/121 (4.13%)  10/122 (8.20%)  17/122 (13.93%)  9/119 (7.56%)  18/115 (15.65%) 
DIZZINESS  1  1/121 (0.83%)  5/122 (4.10%)  2/122 (1.64%)  6/119 (5.04%)  3/115 (2.61%) 
HEADACHE  1  3/121 (2.48%)  3/122 (2.46%)  1/122 (0.82%)  2/119 (1.68%)  4/115 (3.48%) 
SOMNOLENCE  1  2/121 (1.65%)  0/122 (0.00%)  1/122 (0.82%)  4/119 (3.36%)  2/115 (1.74%) 
Psychiatric disorders           
INSOMNIA  1  1/121 (0.83%)  7/122 (5.74%)  2/122 (1.64%)  7/119 (5.88%)  7/115 (6.09%) 
HALLUCINATION  1  1/121 (0.83%)  1/122 (0.82%)  1/122 (0.82%)  6/119 (5.04%)  1/115 (0.87%) 
ANXIETY  1  4/121 (3.31%)  2/122 (1.64%)  1/122 (0.82%)  2/119 (1.68%)  2/115 (1.74%) 
Respiratory, thoracic and mediastinal disorders           
NASOPHARYNGITIS  1  4/121 (3.31%)  2/122 (1.64%)  4/122 (3.28%)  2/119 (1.68%)  1/115 (0.87%) 
Skin and subcutaneous tissue disorders           
HYPERHIDROSIS  1  4/121 (3.31%)  1/122 (0.82%)  1/122 (0.82%)  2/119 (1.68%)  0/115 (0.00%) 
Vascular disorders           
HYPERTENSION  1  3/121 (2.48%)  2/122 (1.64%)  4/122 (3.28%)  2/119 (1.68%)  2/115 (1.74%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Research
Organization: Bial – Portela & Cª, S.A.
Phone: +351 229 866 100
EMail: jose.rocha@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01568073     History of Changes
Other Study ID Numbers: BIA-91067-301
2010-021860-13 ( EudraCT Number )
First Submitted: March 29, 2012
First Posted: April 2, 2012
Results First Submitted: November 26, 2014
Results First Posted: January 8, 2015
Last Update Posted: September 18, 2015