Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

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: NCT02284854
Recruitment Status : Completed
First Posted : November 6, 2014
Results First Posted : January 8, 2015
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: BIA 2-093
Drug: Carbamazepine
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B
Hide Arm/Group Description Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Period Title: Overall Study
Started 23 20
Completed 18 20
Not Completed 5 0
Arm/Group Title Group A Group B Total
Hide Arm/Group Description Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + 400 mg twice-daily Total of all reporting groups
Overall Number of Baseline Participants 23 20 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 20 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
20
 100.0%
43
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 20 participants 43 participants
Female
10
  43.5%
7
  35.0%
17
  39.5%
Male
13
  56.5%
13
  65.0%
26
  60.5%
1.Primary Outcome
Title Cmax (BIA 2-093) - the Maximum Plasma Concentration
Hide Description Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg
Time Frame Day 7 to 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A
Hide Arm/Group Description:
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax ESL (D7 ESL 800mg) 18601  (3164)
Cmax ESL (D35 ESL 800mg) 14591  (1800)
2.Primary Outcome
Title Cmax (CBZ) - the Maximum Plasma Concentration
Hide Description Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg
Time Frame Day 28 to 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group B
Hide Arm/Group Description:
Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax CBZ (D28 CBZ 400 mg twice-daily) 10414  (1896)
Cmax CBZ (D35 CBZ 400 mg twice-daily) 9719  (2019)
3.Primary Outcome
Title Cmax (CBZE) - the Maximum Plasma Concentration
Hide Description

Reference - Day 28 following twice-daily oral administration of CBZ 400 mg twice-daily Test - Day 35 following twice-daily oral administration of CBZ 400 mg twice-daily

CBZE - carbamazepine-epoxide is the active metabolite of CBZ

Time Frame Day 28 to 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group B
Hide Arm/Group Description:
Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax CBZE (D28 CBZ 400 mg twice-daily) 1562  (429)
Cmax CBZE (D35 CBZ 400 mg twice-daily) 1560  (332)
4.Primary Outcome
Title AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093
Hide Description Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg
Time Frame Day 7 to 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A
Hide Arm/Group Description:
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
AUC0-t ESL (D7 ESL 800mg) 276836  (43062)
AUC0-t ESL (D35 ESL 800mg) 188648  (23897)
5.Primary Outcome
Title AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ
Hide Description Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg
Time Frame Day 28 to 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group B
Hide Arm/Group Description:
Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
AUC0-t CBZ (D28 CBZ 400 mg twice-daily) 104494  (16344)
AUC0-t CBZ (D35 CBZ 400 mg twice-daily) 94394  (17230)
6.Primary Outcome
Title AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE
Hide Description

Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg

CBZE - carbamazepine-epoxide is the active metabolite of CBZ

Time Frame Day 28 to 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group B
Hide Arm/Group Description:
Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
AUC0-t CBZE (D28 CBZ 400 mg twice-daily) 15322  (3857)
AUC0-t CBZE (D35 CBZ 400 mg twice-daily) 14953  (3121)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CBZ 200 mg CBZ 400 mg CBZ 400 mg Twice-daily ESL 800 mg + CBZ 400 mg Twice-daily ESL 800 mg ESL 800 mg + CBZ 200 mg ESL 800 mg + CBZ 400 mg Before Treatment After Treatment
Hide Arm/Group Description Group B CBZ 200 mg Group B CBZ 400 mg Group B CBZ 400 mg twice-daily Group A + B ESL 800 mg + CBZ 400 mg twice-daily Group A ESL 800 mg Group A ESL 800 mg + CBZ 200 mg Group A ESL 800 mg + CBZ 400 mg Group A and B Before treatment Group A and B After treatment
All-Cause Mortality
CBZ 200 mg CBZ 400 mg CBZ 400 mg Twice-daily ESL 800 mg + CBZ 400 mg Twice-daily ESL 800 mg ESL 800 mg + CBZ 200 mg ESL 800 mg + CBZ 400 mg Before Treatment After Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CBZ 200 mg CBZ 400 mg CBZ 400 mg Twice-daily ESL 800 mg + CBZ 400 mg Twice-daily ESL 800 mg ESL 800 mg + CBZ 200 mg ESL 800 mg + CBZ 400 mg Before Treatment After Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/39 (0.00%)   0/23 (0.00%)   0/21 (0.00%)   0/19 (0.00%)   0/43 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CBZ 200 mg CBZ 400 mg CBZ 400 mg Twice-daily ESL 800 mg + CBZ 400 mg Twice-daily ESL 800 mg ESL 800 mg + CBZ 200 mg ESL 800 mg + CBZ 400 mg Before Treatment After Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/20 (55.00%)   9/20 (45.00%)   12/20 (60.00%)   21/39 (53.85%)   14/23 (60.87%)   10/21 (47.62%)   10/19 (52.63%)   0/43 (0.00%)   4/38 (10.53%) 
Blood and lymphatic system disorders                   
Lymphadenopathy  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  3/19 (15.79%)  0/43 (0.00%)  0/38 (0.00%) 
Cardiac disorders                   
Palpitations  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Ear and labyrinth disorders                   
Tinnitus  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Eye disorders                   
Vision blurred  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  3/39 (7.69%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Gastrointestinal disorders                   
Abdominal discomfort  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Abdominal pain  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  2/39 (5.13%)  0/23 (0.00%)  0/21 (0.00%)  2/19 (10.53%)  0/43 (0.00%)  1/38 (2.63%) 
Constipation  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Diarrhoea  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  2/39 (5.13%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Dry mouth  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  1/23 (4.35%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Dyspepsia  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Flatulence  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/43 (0.00%)  0/38 (0.00%) 
Hypoaesthesia oral  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Nausea  1/20 (5.00%)  1/20 (5.00%)  1/20 (5.00%)  3/39 (7.69%)  2/23 (8.70%)  0/21 (0.00%)  2/19 (10.53%)  0/43 (0.00%)  0/38 (0.00%) 
Toothache  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Vomiting  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  2/39 (5.13%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
General disorders                   
Asthenia  3/20 (15.00%)  4/20 (20.00%)  7/20 (35.00%)  5/39 (12.82%)  7/23 (30.43%)  3/21 (14.29%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Feeling drunk  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Malaise  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  1/38 (2.63%) 
Oedema peripheral  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Pyrexia  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/43 (0.00%)  0/38 (0.00%) 
Infections and infestations                   
Nasopharyngitis  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Rhinitis  0/20 (0.00%)  1/20 (5.00%)  2/20 (10.00%)  1/39 (2.56%)  0/23 (0.00%)  1/21 (4.76%)  1/19 (5.26%)  0/43 (0.00%)  0/38 (0.00%) 
Investigations                   
Alanine aminotransferase increased  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Gamma-glutamyltransferase increased  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Inspiratory capacity abnormal  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Back pain  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Myalgia  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/43 (0.00%)  0/38 (0.00%) 
Neck pain  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Sensation of heaviness  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  1/38 (2.63%) 
Torticollis  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/43 (0.00%)  0/38 (0.00%) 
Nervous system disorders                   
Disturbance in attention  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Dizziness  3/20 (15.00%)  0/20 (0.00%)  4/20 (20.00%)  8/39 (20.51%)  0/23 (0.00%)  4/21 (19.05%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Dysgeusia  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/43 (0.00%)  0/38 (0.00%) 
Dystonia  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  5/39 (12.82%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Headache  5/20 (25.00%)  2/20 (10.00%)  3/20 (15.00%)  9/39 (23.08%)  4/23 (17.39%)  1/21 (4.76%)  2/19 (10.53%)  0/43 (0.00%)  2/38 (5.26%) 
Paraesthesia  1/20 (5.00%)  0/20 (0.00%)  2/20 (10.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Presyncope  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Sciatica  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  1/38 (2.63%) 
Somnolence  4/20 (20.00%)  1/20 (5.00%)  5/20 (25.00%)  5/39 (12.82%)  4/23 (17.39%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Speech disorder  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Tremor  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Psychiatric disorders                   
Insomnia  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  1/38 (2.63%) 
Reproductive system and breast disorders                   
Dysmenorrhoea  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Menstrual discomfort  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/43 (0.00%)  0/38 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Oropharyngeal pain  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Skin and subcutaneous tissue disorders                   
Hyperhidrosis  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Night sweats  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/39 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Rash erythematous  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Sweat gland disorder  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  2/39 (5.13%)  0/23 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Vascular disorders                   
Hot flush  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  2/39 (5.13%)  0/23 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  0/43 (0.00%)  0/38 (0.00%) 
Orthostatic hypotension  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/39 (2.56%)  0/23 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/43 (0.00%)  0/38 (0.00%) 
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: NCT02284854     History of Changes
Other Study ID Numbers: BIA-2093-129
First Submitted: November 4, 2014
First Posted: November 6, 2014
Results First Submitted: December 9, 2014
Results First Posted: January 8, 2015
Last Update Posted: January 8, 2015