Línies d’investigació.

Assaigs clínics actius

Malaltia de Parkinson

– INTEC PHARMA. IN11004 y IN11004E: Double-blind, multicenter, double-simulated, active-controlled, phase III study to compare the efficacy and safety of the accordion pills carbidopa / levodopa (AP-CD / LD) and immediate release CD / LD in patients with fluctuating Parkinson’s disease. Principal Investigator E. Balaguer.  Hospital Universitari General de Catalunya, Sant Cugat.

– PREXTON. PXT-CL17-001. A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 in Reducing Motor Complications of Levodopa Therapy in Parkinson’s Disease Patients Experiencing End-of-Dose Wearing Off and Levodopa-Induced Dyskinesia. Phase II. 2017. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– BIOGEN: BIIB059. Anti-alpha- synuclein monoclonal antibody in early Parkinson’s Disease. Phase IIa. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– ROCHE: BP39529. A randomized, double-blind, placebo controlled, 52-week Phase II study to evaluate the efficacy of intravenous RO7046015 (PRX002) in participants with early Parkinson’s disease with a 52-week blinded extension(PASADENA). Principal Investigator E. Balaguer.  Hospital Universitari General de Catalunya, Sant Cugat.

Udic

Malaltia d’Alzheimer

– BIOGEN: 221AD301 (EMERGE). Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Aducanumab (BIIB037) in patients with early Alzheimer’s disease. Phase II / III. Principal Investigator A. Ugarte / E. Balaguer. Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– ROCHE: BN 29552 (CREAD),A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab (RO 5490245)  in Patients With Prodromal to Mild Alzheimer’s Disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat. Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– ROCHE: BN 29553 (CREAD2). A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab (RO 5490245)  in Patients With Prodromal to Mild Alzheimer’s Disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– EISAI: E2609-G000-302 (MISSION AD). A Placebo-Controlled, Double-Blind, Parallel-Group, 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s disease. 2017. Principal Investigator E. Balaguer.  Hospital Universitari General de Catalunya, Sant Cugat.

– BOEHRINGER-INGELHEIM: 1346.23 A multi-center, double-blind, parallel-group, randomized controlled study to investigate efficacy, safety and tolerabilityof orally administered BI 425809 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer’s Disease. Fase II. IP. 2016. Principal Investigator E. Balaguer.  Hospital Universitari General de Catalunya, Sant Cugat. Principal Investigator A. Hernández. Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– ACADIA: ACP-103-045. A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

Paràlisi Supranuclear Progresiva

– BIOGEN. 251PP301. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear Palsy. Phase III.  2017. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

Apomorfina sublingual

–Assaig de fase 3, obert, alealorizado i emmascarat, mitjançant un avaluador simple cec, per avaluar APL-130277 comparat amb Apomorfina subcutània en subjectes que responen a Levodopa, amb malaltia de Parkinson complicada per fluctuacions motores.

Historial d’ assaigs clínics

Malaltia de Parkinson

– MERCK SERONO: EMR 701165-024. A Double-blind, Randomized, Placebo-controlled, Parallel-group Phase II Study to Explore the Potential Beneficial Effects of Safinamide on Cognition in Non-demented Patients with Idiopathic Parkinson’s Disease (PD) and Cognitive Impairment. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– MERCK SERONO: OLE28850.Open Phase III study to determine the long-term safety of Safinamide in Patients with Parkinson’s disease. . Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– MERCK SCHERING PLOUGH: P04938. A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– MERCK SCHERING PLOUGH: P05664. A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease. Principal Investigator E. Balaguer.  Hospital Universitari General de Catalunya, Sant Cugat. Principal Investigator A. Ugarte.  Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– MERCK SCHERING PLOUGH: P06153. A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– NOVARTIS: CAFQ056 A2222. 12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson’s Disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– NOVARTIS: CAFQ056 A2223. 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson’s Disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– NOVARTIS: CAFQ056 A2299. An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson’s Patients with L-dopa Induced Dyskinesias. July 2012. Principal Investigator Dr. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– MUNDIPHARMA: OXN 2504. A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled  to study the  Efficacy and Safety of OXN PR in Subjects in subjects with chronic severe pain associated with Parkinson’s disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– BIAL: BIA 91067-301. Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson’s Disease Patients With “Wearing-off” Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical Study. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– UCB: SP 0976. Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson’s Disease. Principal Investigator E. Balaguer.  Hospital Universitari General de Catalunya, Sant Cugat.

– OSMOTICA: ALLAYD-I, OS320-3005 A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson’s Disease Subjects With Levodopa-Induced Dyskinesias. 2015. Principal Investigator E. Balaguer.  Hospital Universitari General de Catalunya, Sant Cugat.

– OSMOTICA: ALLAYD-II. OS320-3006   A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson’s Disease Subjects With Levodopa-Induced Dyskinesias. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– CIVITAS/ACORDA: CVT 301-005. A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena). Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– CIVITAS/ACORDA.CVT-301-004 & extension 004E: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™). Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat

BIOTIE: 14BIO-009: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End-of-Dose “Wearing-Off. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat

Malaltia d’Alzheimer

– NOVARTIS: CAD106 A2203 A 90-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study in Patients With Mild Alzheimer’s Disease (AD) to Investigate the Safety, Tolerability and Abeta-specific Antibody Response Following Repeated i.m. Injections of Adjuvanted CAD106. Phase II. EUDRACT: 2009-012394-35. October 2010. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– GENENTECH (ROCHE): GN ABE 4869g. A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients with Mild to Moderate Alzheimer’s disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– GENENTECH: GN 28525 A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients With Mild to Moderate Alzheimer’s Disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– ROCHE: BP 28248. A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of RO4602522 Added to Background Alzheimer’s Disease Therapy in Patients With Moderate Severity Alzheimer’s Disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– SERVIER: CL2-38093-012. A randomized, multicenter Phase IIb study to investigate the efficacy and safety of 3 doses of S38093 (2, 5, and 20 mg / day) versus placebo, associated with donepezil (10 mg / day) in patients with moderate Alzheimer’s disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– EISAI: BAN 2401-G000-201. A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease. Phase II. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– LUPIN: LRP / LND101001. A Randomized, Double-blind, Placebo-controlled, Parallel Group, Comparative, Multicenter, Phase 2 Clinical Study to Evaluate Efficacy and Safety of Two Doses of LND101001 Monotherapy in Patients with Mild to Moderate Alzheimer’s Disease. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– LUNDBECK: LU14861A. A randomized, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE 58054 in patients with mild or moderate Alzheimer’s disease treated with Donepezil. Phase III. Principal Investigator A. Ugarte. Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– LUNDBECK: LU14861B/memantina. Open and memantine extension of assay 14861A. Phase III. Principal Investigator A. Ugarte. Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– LUNDBECK: LU14863A. Phase 3 multicenter, randomized, double-blind, comparative, placebo-controlled, and parallel-group clinical trial to assess the efficacy and safety of Lu AE58054 in patients with mild-to-moderate Alzheimer’s disease and treated with acetylcholinesterase inhibitors. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat. Principal Investigator A. Ugarte.  Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– GRIFOLS: IG 1002 AMBAR. A Multicenter, Randomized, Controlled Study To Evaluate The Efficacy and Safety of Short-Term Plasma Exchange Followed by Long-Term Plasmapheresis With Infusion of Human Albumin Combined With Intravenous Immunoglobulin In Patients With Mild-Moderate AD. Phase II. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– LILLY: H8A-MC-LZAX. Effect of Passive Immunization on the Progression of Mild Alzheimer’s Disease: Solanezumab (LY2062430) Versus Placebo. Phase III. Principal Investigator A. Ugarte.  Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– AXOVANT: RVT-101-3001. A Phase III Study to evaluate the Safety and Tolerability of RVT-101 in Subjects with Alzheimer’s disease. Phase III.Principal Investigator E. Balaguer.  Hospital Universitari General de Catalunya, Sant Cugat.

– AXOVANT: RVT-101-3002. A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Alzheimer’s disease. Phase III.Principal Investigator E. Balaguer.  Hospital Universitari General de Catalunya, Sant Cugat.

BOEHRINGER INGELHEIM: 1289.5. Estudio multicéntrico, doble ciego, aleatorizado controlado de grupos paralelos para investigar la eficacia, seguridad y tolerabilidad de BI 409306, administrado oralmente durante un periodo de tratamiento de 12 semanas, comparado con placebo en pacientes con enfermedad de Alzheimer. Fase II. IP: E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– LILLY: D5010C00009. A 24-month randomized, double-blind, placebo-controlled, parallel-group study on the efficacy, safety, tolerability, biomarkers and pharmacokinetics of AZD3293 in early-stage Alzheimer’s disease (AMARANTH Study). Phase. II/III. Principal Investigator A. Ugarte / E. Balaguer.  Hospital Sant Joan de Déu, Manresa, Fundació Althaia

– JANSSEN. 54861911ALZ2003 (EARLY): A phase IIb/III randomized, bouble-blind, placebo-controlled, parallel group, multicenter study investigating the efficacy and safety of JNJ-54861911 in subjects who are asymptomatic at risc for developing Alzheimer’s Dementia.Principal Investigator A. Ugarte / E. Balaguer. Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– LILLY / ASTRAZENECA:  DAYBREAK I8D-MC (AZET). A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer’s disease Dementia. Phase III.  2017. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– HEPTARES. HTL0018318-202. A phase 1b randomized, double-blind, placebo-controlled, parallel group, multi-center study to determine the safety and tolerability of HTL0018318 in subjects with mild to moderate Alzheimer’s disease receiving donepezil or donepezil/memantine. Phase Ib. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

Paràlisis Supranuclear Progresiva

– Alfa Bioresearch: AB 13004. A prospective, multicenter, randomized, double-blind, placebo-controlled, parallels groups phaseIIb/ III study to compare the efficacy and safety of Masitinib versus placebo in the treatment of patients suffering from Progressive Supranuclear Palsy. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

Síndrome X Fràgil

– NOVARTIS: CAFQ056 A2212. An Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of AFQ056 in Adult Patients with Fragile X Syndrome. Phase II. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– NOVARTIS: CAFQ056 B2214. An Open-label Study to Evaluate the Long-term Safety and Tolerability of AFQ056 in Adolescent Patients with Fragile X Syndrome. Phase II. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– NOVARTIS: CAFQ056 B2279. An Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of AFQ056 in Adult Patients with Fragile X Syndrome. Phase II. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– NOVARTIS: CAFQ056 B2278. An Open-label Study to Evaluate the Long-term Safety and Tolerability of AFQ056 in Adolescent Patients with Fragile X Syndrome. Phase II. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– NOVARTIS: CAFQ056 B2154. Sequential, Two-period Study to Assess the Pharmacokinetics, Safety & Tolerability of Single and Multiple Oral Doses of AFQ056 in Patients with FXS (Fragile X Syndrome) Aged 5-11 Years (Cohort 1) and 3-4 Years (Cohort 2). Phase I. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, SantCugat.

-ROCHE: NP27936. A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients with Fragile X Syndrome. Phase II, November 2012. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

Esclerosi Múltiple

– NURON: NU-100-101. A multicenter, double-blind, randomized, placebo-controlled, parallel-group Phase III study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

Epilèpsia

– BIAL: Epidemiological study of depression in patients with focal epilepsy and its impact on quality of life. IMDYVA study (IMPact of Depression and quality of life). Phase IV. 2012. Collaborating researcher. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– UCB: SP 0980. Open-label, Single Arm, Study Evaluating Tolerability and Efficacy of Lacosamide When Added to Levetiracetamwith Withdrawal of Concomitant Sodium Channel Blocking Antiepileptic Drug in Subjects with Uncontrolled Partial-onset Seizures. Phase III. Principal Investigator A. Ugarte. Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– BIAL: BIA 2093-311. Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures:a Double-blind, Randomized, Active-controlled, Parallel-group, Multicenter Clinical Study. Phase III. . Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat. Principal Investigator A. Ugarte / E. Balaguer. Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

Assaigs Clínics no neurològics

– LEON FARMA: CF 111/302. Double-blind, double-masked, randomized, double-blind, pivotal Phase III study to compare the contraceptive efficacy, tolerability and safety of LF111 (Drospirenone) for 9 cycles with Cerazette (Desogestrel 0.075 mg). Research Associate Investigator and Management: E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.

– NOVARTIS. PERSPECTIVE. CLCZ696B2320. A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Heart Failure and Preserved Ejection Fraction. Phase III. Principal Investigator E. Balaguer. Hospital Universitari General de Catalunya, Sant Cugat.