Trial Outcomes & Findings for Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy (NCT NCT00980746)

Last Updated: 2016-06-22

Results Overview

Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

557 participants

Primary outcome timeframe

17 weeks

Results posted on

2016-06-22

Participant Flow

Date first subject enrolled: 06 Nov 2007 Date last subject completed: 18 Nov 2008 Randomised and treated: 557. Analyzed for efficacy (per-protocol \[PP\]): 403. Analyzed for safety: 557.

During the 2week baseline period,current neuropathic pain drug therapy was discontinued and subjects had to be free of any medication that could affect efficacy(except authorized rescue medication)for 2weeks before start of double-blind study treatment.In case of unbearable pain, this drug-free period could be reduced,but had to be at least 7 days.

Participant milestones

Participant milestones
Measure	ESL 1200 mg QD Eslicarbazepine acetate (ESL) 1200 mg once daily. ESL tablets, scored to allow dose titration during the titration period.	ESL 400 mg BD ESL 400 mg twice daily ESL tablets, scored to allow dose titration during the titration period.	ESL 600 mg BID ESL 600 mg twice daily ESL tablets, scored to allow dose titration during the titration period.	ESL 800 mg BID ESL 800 mg twice daily ESL tablets, scored to allow dose titration during the titration period.	ESL 800 mg QD ESL 800 mg once-daily ESL tablets, scored to allow dose titration during the titration period.	Placebo Placebo Placebo : oral route
Overall Study STARTED	85	89	95	100	92	96
Overall Study Randomized	85	89	95	100	92	96
Overall Study Safety Population	85	89	95	100	92	96
Overall Study Per-protocol	55	66	73	62	73	74
Overall Study COMPLETED	58	67	75	64	75	78
Overall Study NOT COMPLETED	27	22	20	36	17	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ESL 1200 mg QD n=85 Participants Eslicarbazepine acetate 1200 mg once daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 400 mg BD n=89 Participants ESL 400 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 600 mg BID n=95 Participants Eslicarbazepine 600 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 800 mg BID n=100 Participants Eslicarbazepine acetate 800 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 800 mg QD n=92 Participants ESL 800 mg once-daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	Placebo n=96 Participants Placebo Placebo : oral route	Total n=557 Participants Total of all reporting groups
Age, Customized <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants
Age, Customized Between 18 and 65 years	53 participants n=5 Participants	61 participants n=7 Participants	61 participants n=5 Participants	61 participants n=4 Participants	59 participants n=21 Participants	65 participants n=8 Participants	360 participants n=8 Participants
Age, Customized >=65 years	32 participants n=5 Participants	28 participants n=7 Participants	34 participants n=5 Participants	39 participants n=4 Participants	33 participants n=21 Participants	31 participants n=8 Participants	197 participants n=8 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	48 Participants n=7 Participants	56 Participants n=5 Participants	56 Participants n=4 Participants	50 Participants n=21 Participants	57 Participants n=8 Participants	309 Participants n=8 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	41 Participants n=7 Participants	39 Participants n=5 Participants	44 Participants n=4 Participants	42 Participants n=21 Participants	39 Participants n=8 Participants	248 Participants n=8 Participants

PRIMARY outcome

Timeframe: 17 weeks

Outcome measures

Outcome measures
Measure	ESL 1200 mg QD n=85 Participants Eslicarbazepine acetate 1200 mg once daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 400 mg BD n=89 Participants ESL 400 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 600 mg BID n=95 Participants Eslicarbazepine 600 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 800 mg BID n=100 Participants Eslicarbazepine acetate 800 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 800 mg QD n=92 Participants ESL 800 mg once-daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	Placebo n=96 Participants Placebo Placebo : oral route
Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain	-1.7546 units on a scale Standard Error 0.2352	-2.2865 units on a scale Standard Error 0.2325	-1.6746 units on a scale Standard Error 0.2312	-1.8353 units on a scale Standard Error 0.2260	-1.9829 units on a scale Standard Error 0.2328	-1.5801 units on a scale Standard Error 0.2311

Adverse Events

ESL 1200 mg QD

Serious events: 7 serious events

Other events: 11 other events

Deaths: 0 deaths

ESL 400 mg BD

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

ESL 600 mg BID

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

ESL 800 mg BID

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

ESL 800 mg QD

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ESL 1200 mg QD n=85 participants at risk Eslicarbazepine acetate 1200 mg once daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 400 mg BD n=89 participants at risk ESL 400 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 600 mg BID n=95 participants at risk Eslicarbazepine 600 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 800 mg BID n=100 participants at risk Eslicarbazepine acetate 800 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 800 mg QD n=92 participants at risk ESL 800 mg once-daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	Placebo n=96 participants at risk Placebo Placebo : oral route
Cardiac disorders Cardiac failure	1.2% 1/85 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	2.0% 2/100 • Number of events 2 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Cardiac disorders Angina pectoris	1.2% 1/85 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	1.1% 1/89 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	1.0% 1/100 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Cardiac disorders Bradyarrhythmia	0.00% 0/85 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	1.0% 1/100 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/85 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	1.0% 1/100 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Cardiac disorders Acute myocardial infarction	2.4% 2/85 • Number of events 2 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/100 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Renal and urinary disorders Hydronephrosis	0.00% 0/85 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/100 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	1.1% 1/92 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Gastrointestinal disorders Dyspepsia	0.00% 0/85 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	1.1% 1/89 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/100 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Nervous system disorders Loss of consciousness	0.00% 0/85 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	1.1% 1/89 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/100 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Cardiac disorders Cardiac failure congestive	1.2% 1/85 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/100 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Gastrointestinal disorders Ascites	1.2% 1/85 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/100 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Cardiac disorders Bundle branch block left	1.2% 1/85 • Number of events 1 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/100 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized

Other adverse events

Other adverse events
Measure	ESL 1200 mg QD n=85 participants at risk Eslicarbazepine acetate 1200 mg once daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 400 mg BD n=89 participants at risk ESL 400 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 600 mg BID n=95 participants at risk Eslicarbazepine 600 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 800 mg BID n=100 participants at risk Eslicarbazepine acetate 800 mg twice daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	ESL 800 mg QD n=92 participants at risk ESL 800 mg once-daily Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	Placebo n=96 participants at risk Placebo Placebo : oral route
General disorders Nausea	0.00% 0/85 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	7.4% 7/95 • Number of events 7 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	10.0% 10/100 • Number of events 10 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	6.2% 6/96 • Number of events 6 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Gastrointestinal disorders Vomiting	0.00% 0/85 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	10.0% 10/100 • Number of events 10 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Nervous system disorders Dizziness	7.1% 6/85 • Number of events 6 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	5.3% 5/95 • Number of events 5 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	9.0% 9/100 • Number of events 9 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Ear and labyrinth disorders Vertigo	0.00% 0/85 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	6.0% 6/100 • Number of events 6 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Nervous system disorders Headache	5.9% 5/85 • Number of events 5 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/95 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	5.0% 5/100 • Number of events 5 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Nervous system disorders Somnolence	0.00% 0/85 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	6.3% 6/95 • Number of events 6 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/100 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized
Gastrointestinal disorders Abdominal pain upper	0.00% 0/85 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/89 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	5.3% 5/95 • Number of events 5 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/100 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/92 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized	0.00% 0/96 • All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized

Additional Information

Head of Clinical Research Section

BIAL - Portela & Ca, SA

Phone: 351 22 986 6100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER