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Trial record 4 of 18 for:    "Basal Ganglia Disease" | "Benserazide"

Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide

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ClinicalTrials.gov Identifier: NCT01533116
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : November 16, 2015
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Parkinson Disease
Interventions Drug: BIA 9-1067
Drug: Placebo
Drug: levodopa/carbidopa
Drug: levodopa/benserazide
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067
Hide Arm/Group Description

Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.

Placebo

levodopa/carbidopa

levodopa/benserazide

5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

Period Title: Overall Study
Started 14 13 13 12
Completed 12 12 12 12
Not Completed 2 1 1 0
Arm/Group Title Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067 Total
Hide Arm/Group Description

Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.

Placebo

levodopa/carbidopa

levodopa/benserazide

5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

Total of all reporting groups
Overall Number of Baseline Participants 14 13 13 12 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 13 participants 12 participants 52 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
13
 100.0%
13
 100.0%
12
 100.0%
52
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 13 participants 12 participants 52 participants
Female
7
  50.0%
6
  46.2%
6
  46.2%
6
  50.0%
25
  48.1%
Male
7
  50.0%
7
  53.8%
7
  53.8%
6
  50.0%
27
  51.9%
1.Primary Outcome
Title Cmax - Maximum Plasma Concentration
Hide Description Cmax - maximum plasma concentration Cmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Time Frame pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
Hide Outcome Measure Data
Hide Analysis Population Description
According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)
Arm/Group Title Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067
Hide Arm/Group Description:

Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.

Placebo

levodopa/carbidopa

levodopa/benserazide

5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

Overall Number of Participants Analyzed 13 12 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax (Levodopa) Sinemet® 100/25 985  (290) 1245  (524) 1200  (607) 944  (256)
Cmax (Levodopa) Prolopa® 100-25 1704  (682) 2100  (907) 1727  (957) 1795  (788)
Cmax (3-OMD) Sinemet® 100/25 456  (130) 307  (106) 167  (82.5) 115  (54.5)
Cmax (3-OMD) Prolopa® 100/25 688  (230) 360  (96) 206  (110.8) 160  (61.9)
Cmax (BIA 9-1067) Sinemet® 100/25 NA [1]   (NA) 75.0  (39) 263  (82.3) 310  (115)
Cmax (BIA 9-1067) Prolopa® 100/25 NA [1]   (NA) 95.5  (41.1) 281  (153.4) 370  (181.7)
[1]
BIA 9-1067 was not administered
2.Primary Outcome
Title Tmax - Time to Maximum Plasma Concentration
Hide Description Tmax - time to maximum plasma concentration Tmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Time Frame pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
Hide Outcome Measure Data
Hide Analysis Population Description
According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)
Arm/Group Title Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067
Hide Arm/Group Description:

Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.

Placebo

levodopa/carbidopa

levodopa/benserazide

5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

Overall Number of Participants Analyzed 13 12 12 12
Median (Full Range)
Unit of Measure: hours
Tmax (Levodopa) Sinemet® 100/25
0.5
(0.5 to 3.0)
0.75
(0.5 to 3.0)
0.5
(0.5 to 1.5)
1.0
(0.5 to 2.0)
Tmax (Levodopa) Prolopa® 100-25
1.0
(0.5 to 2.0)
1.0
(0.5 to 1.5)
1.0
(0.5 to 2.0)
1.0
(0.5 to 2.0)
Tmax (3-OMD) Sinemet® 100/25
4.0
(4.0 to 6.0)
8.0
(6.0 to 8.0)
6.0
(3.0 to 8.0)
8.0
(4.0 to 8.0)
Tmax (3-OMD) Prolopa® 100/25
4.0
(3.0 to 6.0)
8.0
(4.0 to 8.0)
6.0
(2.0 to 8.0)
4.0
(3.0 to 8.0)
Tmax (BIA 9-1067) Sinemet® 100/25
NA [1] 
(NA to NA)
1.5
(0.5 to 6.0)
3.0
(1.5 to 6.0)
4.0
(1.5 to 6.0)
Tmax (BIA 9-1067) Prolopa® 100/25
NA [1] 
(NA to NA)
3.0
(1.0 to 4.0)
2.5
(0.5 to 6.0)
3.0
(1.0 to 6.0)
[1]
BIA 9-1067 was not administered
3.Primary Outcome
Title AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
Hide Description AUC0-t - area under the plasma concentration-time curve from time 0 to last observed concentration 3-OMD - 3-O-methyl-dopa - metabolite of L-DOPA (levodopa) AUC0-t (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Time Frame pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
Hide Outcome Measure Data
Hide Analysis Population Description
According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)
Arm/Group Title Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067
Hide Arm/Group Description:

Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.

Placebo

levodopa/carbidopa

levodopa/benserazide

5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

Overall Number of Participants Analyzed 13 12 12 12
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
AUC0-t (Levodopa) Sinemet® 100/25 1837  (593) 3386  (1449) 2952  (1003) 2753  (889)
AUC0-t (Levodopa) Prolopa® 100-25 2438  (712) 4115  (1547) 3442  (1225) 4056  (1051)
AUC0-t (3-OMD) Sinemet® 100/25 7631  (1786) 5147  (1534) 2836  (1495) 1751  (988)
AUC0-t (3-OMD) Prolopa® 100/25 11371  (3707) 6205  (1458) 3473  (1962) 2623  (1065)
AUC0-t (BIA 9-1067) Sinemet® 100/25 NA [1]   (NA) 223  (58.2) 872  (412) 1101  (525)
AUC0-t (BIA 9-1067) Prolopa® 100/25 NA [1]   (NA) 232  (82.4) 836  (497) 1185  (562)
[1]
BIA 9-1067 was not administered
4.Primary Outcome
Title tEmax - Time of Occurrence of Maximum Observed Effect on S-COMT Activity
Hide Description tEmax - time of occurrence of maximum observed effect on S-COMT activity COMT - Catechol-O-Methyltransferase
Time Frame pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
Hide Outcome Measure Data
Hide Analysis Population Description
According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)
Arm/Group Title Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067
Hide Arm/Group Description:

Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.

Placebo

levodopa/carbidopa

levodopa/benserazide

5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

Overall Number of Participants Analyzed 13 12 12 12
Mean (Standard Deviation)
Unit of Measure: hours
8.12  (8.15) 2.71  (2.16) 4.67  (1.92) 3.50  (2.41)
5.Primary Outcome
Title AUEC0-24 - Area Under the Effect-time Curve (AUEC) to 24 h Post-dose
Hide Description AUEC0-24 - Area under the effect-time curve (AUEC) to 24 h post-dose.
Time Frame pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
Hide Outcome Measure Data
Hide Analysis Population Description
According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)
Arm/Group Title Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067
Hide Arm/Group Description:

Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.

Placebo

levodopa/carbidopa

levodopa/benserazide

5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

Overall Number of Participants Analyzed 13 12 12 12
Mean (Standard Deviation)
Unit of Measure: pmol/mg Hb/h.h
906  (276) 454  (97.3) 319  (134) 226  (177)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067
Hide Arm/Group Description

Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.

Placebo

levodopa/carbidopa

levodopa/benserazide

5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28

BIA 9-1067

levodopa/carbidopa

levodopa/benserazide

All-Cause Mortality
Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg BIA 9-1067
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/14 (78.57%)   9/13 (69.23%)   11/13 (84.62%)   9/12 (75.00%) 
Ear and labyrinth disorders         
Ear discomfort  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Ear pain  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%) 
Eye disorders         
Dark circles under eyes  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Eye pain  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Eye pruritus  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%) 
Ocular hyperaemia  1/14 (7.14%)  1/13 (7.69%)  2/13 (15.38%)  0/12 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  0/14 (0.00%)  2/13 (15.38%)  0/13 (0.00%)  1/12 (8.33%) 
Abdominal pain upper  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Constipation  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%) 
Diarrhoea  2/14 (14.29%)  2/13 (15.38%)  2/13 (15.38%)  1/12 (8.33%) 
Eructation  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%) 
Nausea  2/14 (14.29%)  1/13 (7.69%)  1/13 (7.69%)  1/12 (8.33%) 
General disorders         
Chest discomfort  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%) 
Chills  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%) 
Fatigue  1/14 (7.14%)  0/13 (0.00%)  2/13 (15.38%)  1/12 (8.33%) 
Feeling hot  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%) 
Vessel puncture site reaction  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%) 
Infections and infestations         
Upper respiratory tract infection  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications         
Excoriation  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  1/12 (8.33%) 
Sunburn  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%) 
Investigations         
Blood potassium increased  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Hepatic enzyme increased  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%) 
Muscle spasms  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%) 
Nervous system disorders         
Disturbance in attention  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  2/12 (16.67%) 
Dizziness  2/14 (14.29%)  3/13 (23.08%)  1/13 (7.69%)  1/12 (8.33%) 
Dysgeusia  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Headache  2/14 (14.29%)  1/13 (7.69%)  1/13 (7.69%)  3/12 (25.00%) 
Hypoaesthesia  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%) 
Sensory disturbance  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%) 
Somnolence  5/14 (35.71%)  3/13 (23.08%)  5/13 (38.46%)  6/12 (50.00%) 
Psychiatric disorders         
Euphoric mood  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%) 
Renal and urinary disorders         
Polyuria  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%) 
Urine odour abnormal  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%) 
Reproductive system and breast disorders         
Dysmenorrhoea  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  1/12 (8.33%) 
Nasal congestion  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Oropharyngeal pain  1/14 (7.14%)  1/13 (7.69%)  1/13 (7.69%)  0/12 (0.00%) 
Rhinorrhoea  1/14 (7.14%)  1/13 (7.69%)  0/13 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders         
Acne  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Dry skin  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%) 
Eczema  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Erythema  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Photosensitivity reaction  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Rash  1/14 (7.14%)  0/13 (0.00%)  2/13 (15.38%)  1/12 (8.33%) 
Rash maculo-papular  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%) 
Skin hyperpigmentation  2/14 (14.29%)  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%) 
Vascular disorders         
Hot flush  1/14 (7.14%)  1/13 (7.69%)  0/13 (0.00%)  0/12 (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
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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01533116     History of Changes
Other Study ID Numbers: BIA-91067-118
First Submitted: January 24, 2012
First Posted: February 15, 2012
Results First Submitted: July 22, 2015
Results First Posted: November 16, 2015
Last Update Posted: November 16, 2015