Lines of investigation.
Active clinical trials
Clinical trials at PARKINSON
P2B001-003. Phase III trial of PHARMA TWO 2. A new idea: a capsule that combines low doses of rasagiline and pramipexole (two drugs already sold separately) in the initial Parkinson’s. It is intended to maintain or improve the efficacy of the two compounds or reduce the possible side effects (drowsiness, edema in the legs, impulse control disorder).
– PHARMA TWO 2: P2B001-003. A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. 2018. IP. Hospital Universitari General de Catalunya.
CTH-302. SUNOVION phase III test. A practical and democratic solution for treating motor blockages in advanced Parkinson’s disease. Comparing the use on demand (according to the patient’s blockages) of a new sublingual apomorphine formulation. There has already been subcutaneous apomorphine for many years, but its administration by subcutaneous injection or by perfusion pump has limited its use. This clinical trial compares the 2 drugs and evaluates their efficacy and safety
– SUNOVION: CTH-302. An Open- Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations. 2018. IP. Hospital Universitari General de Catalunya. Fase III.
AMBLED: PXT-CL17-001. Assaig de fase IIa de Prexton / Lundbeck de breu durada i recerca de diferents dosis. Una aportació original en un greu problema clínic sense una fàcil solució: les discinèsies. S’ avalua un modulador glutamatèrgic front a placedo, per conèixer la seva seguretat i la seva eficàcia en dicinesias coreicas invalidants.
– PREXTON: PXT-CL17-001. AMBLED. 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. 2017-2018. IP. Hospital Universitari General de Catalunya.
Open label extension sudy with sublingual apomorphine to assess its long-term safety (for 3 years). It offers a practical solution for its timely use, at the patient’s discretion, of motor blockages, without interfering with the rest of the patient’s usual medication.
– SUNOVION: CTH-301: A phase 3, open-label study, examining the safety, tolerability and long-term efficacy of APL-130277 in patients with a response to levodopa with Parkinson’s disease complicated by motor fluctuations (“OFF” episodes).
CONTERA: JM010-CS03. An imaginative combination in a serious clinical problem: abnormal movements and dyskinesias. The efficacy and safety of Zolmitriptan and Bupropion, both at low doses, are studied in this complication of advanced Parkinson’s disease.
-CONTERA: JM010-CS03. Randomized, double-blind, placebo-controlled study of parallel groups in patients with Parkinson’s disease with moderate to severe dyskinesia to assess the efficacy and safety and tolerability of two dose combinations of JM-010.
IPX203-B16-02 (RISE-PD): A new formulation of Levodopa in Parkinson’s disease with motor Off periods, such as nocturnal akinesia. It is compared against standard Levodopa-Carbidopa. Similar to Rytary (Levodopa extended release) but with simultaneous acute effect. There is an open label extension period with a drug delivery for patients during 3 years.
– IMPAX: IPX203-B16-02 (RISE-PD). Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release Carbidopa-Levodopa in Parkinson’s Disease Patients with Motor Fluctuations.
Clinical trials at ALZHEIMER'S
EISAI: BAN2401-G000-301 (CLARITY AD). An opportunity in the treatment of Alzheimer’s: monoclonal antiamyloid antibody to assess risk / benefit in reducing clinical worsening and amyloid burden. A phase III clinical trial that attempts to replicate the positive outcome of its phase II.
EISAI: BAN2401-G000-301 (CLARITY AD). A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phaseto ConfirmSafety and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease
Roche: WN29922 (GRADUATE). A reference essay. An anti-amyloid monoclonal antibody administered subcutaneously, which could replicate the positive result of the EMERGE trial, with Aducanumab from Biogen. In this case, Gantenereumab is compared to placebo, in order to evaluate the efficacy (in various neuropsychological like Clinical Dementia Rating) and the safety (with periodic controls in cerebral MRi) of increasing doses of this drug. An extended long-term extension is planned.
-Roche: WN29922 (GRADUATE). A phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of Gantenerumab in patients with early (prodromal to mild) Alzheimer’s disease
A surprising hypothesis and an imaginative solution: a clinical trial to assess the efficacy and safety of a drug (administered orally) that could inhibit the proteases of a gum bacterium (P. gingivalis) that has been detected in the brain of patients with Alzheimer’s disease. It is an approach to this pathology, absolutely different from the other projects under way.
– CORTEXYME: OR388-010 (GAIN): A Randomized, Double-Blind, Placebo-Controlled Study of COR388HCI in Subjects with Alzheimer’s Disease. Phase II/III