Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

CVXL-0107 a glutamate release inhibitor, has shown evidence of antiparkinsonian and antidyskinetic activity in a macaque model and has shown a significant effect on the UPDRS-III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) while "ON", as well as an increase of "ON-time" without dyskinesia or without troublesome dyskinesia in a previous phase 2a proof of concept study. This study will confirm the efficacy of CVXL-0107 in combination with optimal dose of levodopa on motor symptoms of Parkinson's disease (PD) .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CleveXel Pharma
• Treatments: Levodopa

Criteria

Inclusion Criteria:

1. Signed written Informed Consent

2. Male and female patient aged 40 -75 years

3. Clinical diagnosis of idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria

4. Advanced PD with clear daily motor fluctuations and dyskinesia with optimal levodopa-based therapy

5. At least 2 hours in "OFF" state per day including morning OFF

6. Predictable "OFF" in the morning on awakening prior to receiving morning dose of levodopa

7. During an acute levodopa challenge test : Motor improvement of at least 30% on the MDS-UPDRS part III and AIMS score ≥ 1 at least two time points

8. Patient with dyskinesia: MDS-UPDRS items 4.1 ("time spent with dyskinesia") and 4.2 ("functional impact of dyskinesia") scores ≥ 1 at Screening

9. Hoehn and Yahr stages of 2-4 in the "OFF" state at Screening

10. Stable doses and regimens of antiparkinsonian medications for at least the last month prior to randomization (levodopa, dopamine agonists and selective monoamine oxidase type B inhibitors (selegiline, rasagiline))

11. Anti-PD therapy intended to remain constant throughout the course of the study

12. Normal platelets count

13. Mini-mental state examination (MMSE)≥24 at Screening

14. PD patient treated by DBS can be included if surgery occurred at least one year before the study

15. Patient with health insurance

16. Female of childbearing potential with an effective contraception

Exclusion Criteria:

1. Any relevant neurologic or psychiatric disease, except idiopathic PD

2. Any secondary causes for Parkinsonism or other neurodegenerative disorder with Parkinsonism symptoms

3. Any neurosurgical intervention for PD planned during the study period

4. Neuroleptics and any D2-receptor antagonists within the last 3 months before Screening

5. Amantadine, Riluzole, dextromethorphan, apomorphine continuous infusion (pump), morphine, or memantine, during the last month before screening and during the study duration

6. History of psychosis or treatment with any antipsychotic drugs within the last 2 years

7. History of seizure or epilepsy, or treatment with anticonvulsant drugs within the last year

8. Any clinically significant unstable medical illness in the last month before randomization (e.g. unstable angina, unstable vascular disease etc)

9. Anti-cancer treatment within the 3 months before Screening

10. Treatment with anticoagulant drugs

11. Any clinically significant renal (serum creatinine level ≥1.5x ULN or dialysis) or hepatic (liver enzyme values≥2x ULN) disease

12. Any clinically significant condition that may compromise the safety of patient or the conduct of the study protocol according to Investigators' opinion.

13. Known genetic disorder of human UDP-glucuronosyltransferase

14. Participation in another trial with any investigational product within the last month before randomization or intake of any investigational product

15. Pregnant, breastfeeding or lactating female