Clinical trials: BIA
Parkinson's Disease
Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202
The objectives as stated in the study protocol were as follows: To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy…
- Trial name
- NCT02763800
- Testing
- BIA 3-202
- Where
- United Kingdom
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Epilepsy
A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093
The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.
- Trial name
- NCT02170077
- Testing
- BIA 2-093
- Where
- Portugal
- Volunteers
- 144 people
- Sponsor
- Bial - Portela C S.A.
Hypertension, Chronic Heart Failure
Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453
The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple rising dose regimens of BIA 5-453.
- Trial name
- NCT02840565
- Testing
- BIA 5-453
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Hypertension, Chronic Heart Failure
Tolerability, Pharmacokinetics and Dopamine ß-hydroxylase (DßH) Inhibition Profile of BIA 5-453
The purpose of this study is to assess the safety and tolerability of BIA 5-453 after single oral doses
- Trial name
- NCT02845037
- Testing
- BIA 5-453
- Where
- France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Parkinson Disease
Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156
The study is designed to determine the absorption, distribution, metabolism and elimination (ADME) of BIA 28-6156 in humans, further explore the PK of BIA 28-6156, evaluate the extent of distribution of total radioactivity into…
- Trial name
- NCT05220072
- Testing
- Carbon-14 BIA 28-6156
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bial R&D Investments, S.A.
Hypertension, Congestive Heart Failure
Bioavailability Study of BIA 5-453
The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.
- Trial name
- NCT03090568
- Testing
- BIA 5-453
- Where
- France
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Hypertension, Chronic Heart Failure
Pharmacokinetics of BIA 5-453 and Its Metabolites
The purpose of this study was to assess the effects of age on the pharmacokinetic (PK) profile of BIA 5-453 and its metabolites.
- Trial name
- NCT03090724
- Testing
- BIA 5-453
- Where
- France
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Parkinson's Disease
Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD
The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who…
- Trial name
- ACTIVATE (NCT05819359)
- Testing
- BIA 28-6156 10 mg, BIA 28-6156 60 mg
- Where
- 95 sites in United States, Canada and 9 more
- Volunteers
- 237 people
- Sponsor
- Bial R&D Investments, S.A.
Epilepsy
Pharmacokinetics, Efficacy and Tolerability of BIA 2-093
The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy.
- Trial name
- NCT02170064
- Testing
- BIA 2-093 (Eslicarbazepine acetate)
- Where
- Romania
- Volunteers
- 35 people
- Sponsor
- Bial - Portela C S.A.
Cardiovascular Disease+Pulmonary Disease, Pulmonary Arterial Hypertension
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058
This is a single centre, double-blind, randomised, placebo-controlled, parallel staggered group study of BIA 5-1058 in 11 different cohorts of 15 healthy subjects.
- Trial name
- NCT03708146
- Testing
- BIA 5-1058
- Where
- United Kingdom
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Parkinson Disease
Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide
The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.
- Trial name
- NCT01536366
- Testing
- BIA 9-1067, Repaglinide
- Where
- Portugal
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Parkinson's Disease (PD)
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide
To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa 100 mg/benserazide…
- Trial name
- NCT02169466
- Testing
- BIA 9-1067, Madopar® HBS
- Where
- Portugal
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Bipolar I Disorder
Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
This was an extension study consisting of 2 parts. In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
- Trial name
- NCT01825837
- Testing
- BIA 2-093 1800 mg once daily [Group 1 (Part II)], BIA 2-093 900 mg once daily [Group 2 (Part II)], BIA 2-093 300 mg once daily [Group 3 (Part II)]
- Volunteers
- 104 people
- Sponsor
- Bial - Portela C S.A.
Parkinson Disease
Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics
The purpose of the study was to To investigate whether the administration of BIA 6-512 (25 mg, 50 mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when administered in combination with a single-dose…
- Trial name
- NCT03094156
- Testing
- BIA 6-512, Madopar® 250, Comtan®
- Where
- Portugal
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Pulmonary Arterial Hypertension
Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH (Zamicastat)
This Study evaluates the pharmacokinetic (PK) profile of different zamicastat doses in Pulmonary arterial hypertension (PAH) patients to find the most promising therapeutic dosage range for the treatment of PAH disease
- Trial name
- NCT04316143
- Testing
- Oral zamicastat
- Where
- 13 sites in Austria, Germany and 5 more
- Volunteers
- 33 people
- Sponsor
- Bial - Portela C S.A.
Parkinson's Disease (PD)
Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067
The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.
- Trial name
- NCT02071810
- Testing
- BIA 9-1067
- Where
- France
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Epilepsy
Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients
This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.
- Trial name
- NCT01422720
- Testing
- Eslicarbazepine Acetate
- Where
- 48 sites in Austria, Bulgaria and 8 more
- Volunteers
- 72 people
- Sponsor
- Bial - Portela C S.A.
BIPOLAR I DISORDER
Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder
The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with placebo, as therapy in patients with acute…
- Trial name
- NCT01824602
- Testing
- Eslicarbazepine acetate 1800 mg, Eslicarbazepine acetate 1200 mg, Eslicarbazepine acetate 600 mg
- Volunteers
- 38 people
- Sponsor
- Bial - Portela C S.A.
Parkinson's Disease
Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg)
The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA 3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4 different single doses of BIA 3-202 (50 mg…
- Trial name
- NCT02763839
- Testing
- BIA 3-202, Sinemet 25/100
- Where
- Portugal
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Parkinson's Disease (PD)
Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics
The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a…
- Trial name
- NCT02169414
- Testing
- BIA 9-1067 5 mg, BIA 9-1067 25 mg, levodopa/carbidopa 100/25
- Where
- France
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.