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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02641054
• Date of registration: 07/12/2015
• Prospective Registration: Yes
• Primary sponsor: CleveXel Pharma
• Public title: Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease
• Scientific title: Double-Blind Randomized Placebo-Controlled Cross-Over Phase IIa Trial to Evaluate Efficacy of CVXL-0107 on Parkinson-Related Symptoms and Levodopa-Induced Dyskinesia in Advanced Parkinson's Disease Patients Using a Levodopa Challenge Test
• Date of first enrolment: February 2016
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02641054
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Jean-Christophe Corvol, MD, PhD
• Affiliation: CIC-Neurologie, bâtiment ICM, Hôpital Pitié-Salpêtrière, 47/83 Bd de l'Hôpital, 75013 Paris, France

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Parkinson Disease

Intervention(s)

Drug: CVXL-0107

Drug: Levodopa

Drug: Placebo

Primary Outcome(s)

Change in AIMS ( Abnormal Involuntary Movement Scale) score [Time Frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37 = challenge test day): at baseline (before L-Dopa administration), then every 20 minutes during the first hour and then every 30 minutes during 5 hours]

Change in MDS-UPDRS part III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III) score. [Time Frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day): at baseline (before L-Dopa administration), then every 20 minutes during the first hour and then every 30 minutes during 5 hours.]

Secondary Outcome(s)

Assessment of total daily "ON" time in Patients Diaries [Time Frame: During 3 days, prior to visit 3 (days 11-13) and prior to visit 4 (days 33, 34, 35)]

Assessment of daily "ON" time without dyskinesia in Patients Diaries [Time Frame: During 3 days; prior to visit 3 (days 11-13) and prior to visit 4 (days 33, 34, 35)]

Area Under the Curve [AUC] of CVXL-0107 concentrations [Time Frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day)]

Hepatic laboratory safety of CVXL-0107 [Time Frame: at visit 3 (day 14) and visit 4 (day 36)]

Incidence of Clinical Treatment-Emergent Adverse Events [Safety and Tolerability] [Time Frame: at visit 3 (day 14) and visit 4 (day 36)]

Area Under the Curve [AUC] of levodopa concentrations [Time Frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day)]

Hematology laboratory safety of CVXL-0107 [Time Frame: at visit 3 (day 14) and visit 4 (day 36)]

Secondary ID(s)

CT-CVXL-0107-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors