Clinical Trials
In continuous collaboration with laboratories and associations, it offers its patients the possibility, if they meet the inclusion criteria, to participate in studies and trials of innovative drugs.
We have a long experience in performing this type of studies aimed at patients with different neurological pathologies and regardless of their place of residence.
UCB EP0162: A double-blind outpatient study to investigate the efficacy and safety of a single administration of Staccato alprazolam in study participants ≥12 years of age with stereotypical prolonged seizures . Alprazolam
Double-blind outpatient study to investigate the efficacy and safety of a single administration of Staccato alprazolam in study participants ≥12 years of age with prolonged stereotyped seizures
Criteria
- Patients 12 years of age or older
- With a diagnosis of focal and/or generalized epilepsy and seizures of prolonged duration.
- 4 or more prolonged crises in the last 6 months
Principal Investigator DR GIL-NAGEL
UCB EP0165: An open-label outpatient extension study to evaluate the safety and tolerability of Staccato alprazolam in study participants ≥12 years of age with stereotypical prolonged seizures Alprazolam
Open-label outpatient extension study to evaluate the safety and tolerability of alprazolam in patients with stereotypic prolonged seizures in study participants aged 12 years and older.
Criteria
- Patients who have previously participated in the EP0162 study.
Principal Investigator DR GIL-NAGEL
PRAX-562-221: A Phase 2, Double-Blind, Randomized Clinical trial to Explore the Tolerability, Efficacy, and Pharmacokinetics of PRAX-562 in Pediatric Participants with Developmental and epileptic Encephalopathies Followed by an Open-Label Extension.
PRAX-562
Randomized, double-blind, Phase 2 clinical trial to explore the tolerability, efficacy and pharmacokinetics of PRAX-562 in pediatric participants with epileptic and developmental encephalopathies followed by open-label extension.
Cristerios
- Patients between 2 and 18 years of age (included).
- Body weight over 10 kilos.
- With SCN2A mutation (and seizure onset in the first 3 months of life) or SCN8A mutation (and seizure onset in the first 6 months of life).
- At least 8 countable seizures per month.
Principal Investigator DR GIL-NAGEL
NE001: SAFETY AND THERAPEUTIC MEASURES OF TRANSCRANIAL CATHODAL DIRECT CURRENT STIMULATION (TDCS) IN PATIENTS WITH REFRACTORY FOCAL EPILEPSY.
SAFETY AND THERAPEUTIC MEASURES OF CATHODAL TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS) IN PATIENTS WITH REFRACTORY FOCAL EPILEPSY
Criteria:
- Patients over 9 years of age
- Diagnosis of Focal Epilepsy
- At least 3 crises per month during the last year.
Principal Investigator DR GIL-NAGEL
YKP509C003: Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of carisbamate (YKP509) as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in children and adults, with optional open-label extension. Carisbamate.
Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of carisbamate (YKP509) as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults, with optional open-label extension.
Criteria:
- Patients between 4 and 55 years old (included).
- Diagnosed with Lennox-Gastaut Syndrome.
- 8 or more Countable Epileptic Seizures with drop ( Tonic, Atonic or GTC ) in the 4 weeks prior to BSL
- 1-4 Antiepileptic drugs at a stable dose during the 4 weeks prior to the baseline visit.
Principal Investigator DR GIL-NAGEL
XPF-010-301: A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizure XEN1101.
Randomized, double-blind, placebo-controlled, multicenter phase 3 study to evaluate the safety, tolerability and efficacy of XEN1101 as adjunctive therapy in focal onset seizures.
Criteria:
- Patients 18 years of age or older.
- With diagnosis of Focal Epilepsy.
- With stable doses of 1-3 antiepileptic drugs 4 weeks prior to the baseline visit.
Principal Investigator DR GIL-NAGEL
XPF-010-304: A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Adults Diagnosed With Epilepsy. XEN1101
Multicenter, open-label, long-term study of safety, tolerability and efficacy of XEN1101 in adults diagnosed with epilepsy.
Criteria:
- Patients who have previously participated in the XPF-010-301 study.
Principal Investigator DR GIL-NAGEL
EstuEla2022 : Treatment of refractory epilepsy associated with tuberous sclerosis complex (TSC) with full-spectrum cannabis extract: SPECTRUM”. Cannabis Extract
Treatment, with full spectrum cannabis extract, of refractory epilepsy associated with complex Tuberous Sclerosis (TSC): SPECTRUM”.
Criteria:
- Patients between 2 and 65 years of age (included).
- Diagnosed with epilepsy associated with Tuberous Sclerosis Complexes .
- 4 or more Epileptic Seizures per month.
- On treatment with 1-3 Antiepileptic Drugs at stable doses 4 weeks prior to the Baseline Visit.
Principal Investigator DR GIL-NAGEL
GWEP17005 : An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants with Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) who Experience Inadequately-controlled Seizures Cannabidiol
Single-arm, open-label study to evaluate the safety, pharmacokinetics, and efficacy of adjuvant cannabidiol oral solution (GWP42003-P) in participants with tuberous sclerosis complex (1 month to < 2 years of age), Dravet syndrome (1 year to < 2 years of age), or Lennox-Gastaut syndrome (1 year to < 2 years of age) experiencing inadequately controlled seizures
Criteria:
- Patients with Dravet Syndrome and age between 1 and 2 years old.
- Patients with Lennox-Gastaut syndrome aged between 1 and 2 years.
- Patients with CSD and age between 1 month and 2 years.
- On treatment with 1 or more stable antiepileptic drugs 2 weeks prior to Visit 3
Principal Investigator DR GIL-NAGEL
EXPAND: Deep phenotyping of non-epileptic phenomena in adult patients with Dravet Syndrome . Observational
Deep phenotyping of non-epileptic phenomena in adult patients with Dravet syndrome.
Criteria:
Patients diagnosed with Dravet Syndrome over 18 years of age.
Principal Investigators DR BELTRÁN / DR GIL-NAGEL
eDREXCO: Efficient drugs in Dravet syndrome for Executive and Cognitive Outcomes (eDREXCO). Observational
Effective drugs in Dravet syndrome for executive and cognitive outcomes
Criteria:
- Patients older than 2 years.
- Diagnosed with Dravet syndrome with confirmation of mutation in the SCN1A gene.
- Who has received in the past treatment with any of the following drugs: Fenfluramine, Styripentol, Valproic, Cannabidiol, Topiramate or Clobazam.
Principal Investigators DR VALLS / DR GIL-NAGEL
RAD-GRIN-201: A Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Radiprodil in Patients with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type II. Radiprodil
Multicenter, open-label study to assess the safety, tolerability, pharmacokinetics and effect on seizures and behavioral symptoms of radiprodil in patients with tuberous sclerosis complex (TSC) or focal cortical dysplasia (FCD) type II
Criteria:
- Patients between 6 months and 18 years of age
- Diagnosed with Dysplasia type II (with confirmatory MRI).
- O Diagnosis of TSC (by clinical and / or Genetic confirmation)
- 8 or more Countable Seizures in the 4 weeks prior to Visit 2
- And stable treatment in the 28 days prior to the Screening Visit (V1).
Principal Investigators DR GIL-NAGEL
dBM-DEV : Digital biomarkers development, validation and verification study.
Study of development, validation and verification of digital biomarkers.
Criteria:
- Over 18 years of age.
- Participant uses a compatible smart phone, a smart watch will be provided for the duration of the study.
- The participant has a caregiver with whom he shares his room at night.
- Known REM sleep behavior disorder as defined by the International Classification of Sleep Disorders (ICSD-3) as demonstrated by polysomnography with at least one episode per week (on average over the past month, frequency reported with caregiver assistance).
Principal Investigator DRA KURTIS
AI-PRA Study : Artificial intelligence-based Parkinson’s risk assessment study.
Artificial intelligence-based Parkinson’s risk assessment study.
Criteria:
Over 55 years of age.
- At least one of these requirements:
- Olfactory Loss ( measured with UPSIT )
- REM Sleep Behavior Disorder (confirmed by polysomnography)
- Neurogenic Orthostatic Hypotension.
- Participant uses a compatible smart phone (a smart watch will be provided for the duration of the study)
Principal Investigator DRA KURTIS
AI-PMP Study: AI-based progression and medication response prediction study.
AI-based study on prediction of progression and response to medication.
Criteria:
Diagnosis of Parkinson’s disease according to the MDS criteria.
- Age between 40 and 80 years old (included).
- Participant uses a compatible smart phone (a smart watch will be provided for the duration of the study)
- Patients with atypical parkinsonian syndrome, more than 4 doses of L-Dopa per day (LEED greater than 1500 mg), hallucinations, Hoehn and Yahr greater than 3 in ON will not be included.
Principal Investigator DRA KURTIS
EPILEPSY
NBI-921352-DEE2013A Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE).
Prospective, long-term, interventional, active extension study to evaluate the safety and tolerability of NBI-921352 as adjuvant therapy in subjects with SCN8A developmental and epileptic encephalopathy syndrome (SCN8A-DEE).
Criteria:
- Patients between 12 and 21 years of age (both included) with a diagnosis of SCN8A-DEE.
- History or ongoing motor abnormalities (ataxia, hypotonia, dystonia…).
- History of convulsive or non-convulsive status.
- Beneficial response to sodium channel blockers (phenytoin, valproate, carbamazepine, lacosamide, lamotrigine, rufinamide and oxcarbamazepine).
- At least 4 countable motor epileptic seizures per month.
Principal Investigator DR GIL-NAGEL
BHV7000-303: A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy BHV-7000.
Multicenter, randomized, double-blind, placebo-controlled, phase 2/3 study to evaluate the efficacy, safety and tolerability of BHV-7000 in subjects with refractory focal-onset epilepsy.
Criteria:
- Patients between 18 and 75 years of age.
- 4 or more observable focal seizures per month in the 3 months prior to screnning.
- 1 to 3 antiepileptic drugs in stable dosage 1 month before the baseline visit.
Principal Investigator DR BELTRÁN
BHV7000-201 : A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy. BHV-7000
Long-term, multicenter, global, Phase 2, multicenter safety study designed to evaluate the safety and tolerability of BHV-7000 in subjects with refractory focal epilepsy.
Criteria:
- Patients who have previously participated in the BHV7000-303 study.
Principal Investigator DR BELTRÁN
EP0213 : OPEN-LABEL, SINGLE-ARM, PHASE 3 STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF FENFLURAMINE (HYDROCHLORIDE) IN INFANTS 1 YEAR TO LESS THAN 2 YEARS OF AGE WITH DRAVET SYNDROME Fenfluramine.
PHASE 3, OPEN-LABEL, SINGLE-ARM, PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF FENFLURAMINE (HYDROCHLORIDE) IN INFANTS 1 TO LESS THAN 2 YEARS OF AGE WITH DRAVET SYNDROME
Criteria:
- Patients aged 1-2 years.
- Diagnosed with Dravet Syndrome.
- On treatment with 1 or more antiepileptic drugs at a stable dose 4 weeks prior to the baseline visit.
- 4 or more Countable Motor Crises per month.
- Body Weight 8 kilos or more.
Principal Investigator DR GIL-NAGEL
LP352-301 : A Phase 3 randomized, double-blind, placebo-controlled, multi-center study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with Developmental and Epileptic Encephalopathies (DEE). LP352
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy, safety and tolerability of LP352 in the treatment of seizures in children and adults with developmental and epileptic encephalopathies (DEE).
Criteria:
- Patient with Epileptic and Developmental Encephalopathy (DEE).
- Aged between 2 and 65 years old (included).
- Body weight equal to or greater than 10 kilos.
- They must have Motor Epileptic Seizures.
- At least 4 crises per month during the 3 months prior to the Initial Visit.
- Must take between 1-4 antiepileptic drugs at stable doses 4 weeks prior to the Initial Visit.
Principal Investigator DR GIL-NAGEL
LP352-302 : A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults with Dravet Syndrome LP352.
Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy, safety and tolerability of LP352 in the treatment of seizures in children and adults with Dravet syndrome.
Criteria:
Patient diagnosed with Dravet Syndrome .
- Aged between 2 and 65 years old (included).
- Body weight equal to or greater than 10 kilos.
- They must have Motor Epileptic Seizures.
- At least 4 crises per month during the 3 months prior to the Initial Visit.
- Must take between 1-4 antiepileptic drugs at stable doses 4 weeks prior to the Initial Visit.
Principal Investigator DR GIL-NAGEL
ZX008-1900 An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome. Fenfluramine
Principal Investigator DR GIL-NAGEL
XPF-008-201 A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, with an Open-label Extension ( Xenon Pharmaceuticals Inc. ). XEN1101
Principal Investigator DR GIL-NAGEL
NBI-827104-CSWS2025 Long-Term, Open-Label Extension Study to Evaluate the Safety and Tolerability of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep. NBI-827104
Principal Investigator DR GIL-NAGEL
TAK 935 18 001 A phase 2, Prospective, International, open-label, ulti-site, extension study to Assess the long-Term safety and Tolerability of TAK-935 as adjunctive Therapy in Patients with rare Epilepsy. TAK-935
DR GIL-NAGEL
PTC743-MIT-001-EP Efficacy and Safety Study of Vatiquinone for the Treatment of Mitochondrial Disease Subjects with Refractory Epilepsy. Vatiquinone
Principal Investigator DR GIL-NAGEL
CANDID 1263 (Lou Lou) Endpoint Enabling Study in Cyclin-dependent kinase-like 5 Deficiency Disorder (CDD) . CDKL5 Deficiency Disorder (CDD).
Principal Investigator DR GIL-NAGEL
FENDEEPFenfluramine for the treatment of different types of developmental and epileptic encephalopathies: a pilot trial exploring epileptic and non-epileptic outcomes. Fenfluramine
Principal Investigator DR GIL-NAGEL
1042-TSC-3001 BIORASI A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC), Ganaxolone
Principal Investigator Dr GIL-NAGEL
PD0053 A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, 18-MONTH PHASE 2A STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ORAL UCB0599 IN STUDY PARTICIPANTS WITH EARLY PARKINSON’S DISEASE UCB0599
Principal Investigator Dr. MÓNICA KURTIS
BIA 28-6156-201: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson’s Disease With a Pathogenic Variant in the Glucocerebrosidase(GBA1) BIA 28-6156.
Principal Investigator Dr. MÓNICA KURTIS
PD0053 A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, 18-MONTH PHASE 2A STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ORAL UCB0599 IN STUDY PARTICIPANTS WITH EARLY PARKINSON’S DISEASE UCB0599
Principal Investigator Dr. MÓNICA KURTIS
BIA 28-6156-201: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson’s Disease With a Pathogenic Variant in the Glucocerebrosidase(GBA1) BIA 28-6156.
Principal Investigator Dr. MÓNICA KURTIS
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