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.
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.
– 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.
BIOGEN: 254PD101 (REASON). A phase I trial in early or mild Parkinson’s disease with a disruptive hypothesis. It evaluates the safety of a new generation drug (an antisense oligonucleotide) that is administered intrathecally. It aims to evaluate the safety of this drug, by means of a reduction in the formation of alfasinuclein by inhibiting the LRRK2 gene.
– BIOGEN: 254PD101 (REASON). A Phase 1 Single and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults with Parkinson’s Disease
CEREVEL: CVL-751-PD-001 (TemPo-1) A clinical phase III trial in early and naive Parkinsonian patients to valuate a new dopamine D1 receptor agonist, called Tavapadon. It’s monotherapy for patients who do not they have previously received no antiparkinson medication, for 6 months and compared to placebo.
– CEREVEL: CVL-751-PD-001 (TemPo-1). A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial of the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson’s Disease.
CEREVEL: CVL-751-PD-003 (TemPo-3). A phase III clinical trial in Parkinson’s disease with motor fluctuations, as an added therapy to levodopa to evaluate a new dopamine D1 receptor agonist, called Tavapadon, during 6 months and compared to placebo.
– CEREVEL: CVL-751-PD-003 (TemPo-3). A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial of the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations.
NEURODERM: ND0612-007 Ultra concentrated levodopa to be administered as a continuous subcutaneous infusion, compared to oral levodopa in patients with motor fluctuations and motor blocks. There will be an open label extension.
-NEURODERM: ND0612-007 (BoundLess) . A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy and tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (BoundLess)
SUN PHARMA: SPARC CRL18-06 (PROSEEK). A Phase 2 Study In Early Parkinson’s Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706).– SUN PHARMA: SPARC CRL18-06 (PROSEEK). A phase III clinical trial evaluating efficacy and safety of a thyroxin-hydroxylase inhibitor in patients with early Parkinson’s disease, as monotherapy, with no other medications during for 6 months.
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
CORTEXYME: COR388-010 (GAIN). 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: COR388-010 (GAIN). A Randomized, Double-Blind, Placebo-Controlled Study of COR388HCI in Subjects with Alzheimer’s Disease. Phase II/III
TauRx Therapeutics: TRx-237-039 (LUCIDITY). A phase III clinical trial in mild and moderate Alzheimer’s evaluating the efficacy and safety of an oral drug, called LMTM, to assess its efficacy and safety on the rate of deterioration of cognition and functionality in routine tasks, compared to placebo, for one year . There is an extension open for 1 year.
– TauRx Therapeutics: TRx-237-039 (LUCIDITY). A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 9 Month, Brain Imagin and S&E Study of LMTM in Subjects with Early Alzheimer’s Disease.