Early Parkinson's Disease MedDRA version: 20.0 Level: HLT Classification code 10034005 Term: Parkinson's disease and parkinsonism System Organ Class: 100000004852
Conditions
Interventions
Product Code: P2B001
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
CAS Number: 191217-81-9
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Concent
Sponsors
Pharma Two B Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about his/her participation in this study and has given his/her written informed consent on an EC/IRB approved consent form. 2. Subject is willing and able to comply with all study requirements (protocol, clinic visits, procedures and medication administration). 3. Subject is male or female =35 years of age to =80 years of age at the time of enrollment 4. Subject has Parkinson's disease consistent with the UK Brain Bank Criteria and must have bradykinesia with sequence effect. If rest tremor does not exist must have prominent asymmetry of motor function. 5. Subject with disease duration less than 3 years since diagnosis 6. Subject has a H&Y stage score of =65 years) yes F.1.3.1 Number of subjects for this age range 263
Exclusion criteria
Exclusion criteria: Subjects are not permitted to enroll in the study if any 1 of the following criteria is met. 1. Subject has previously participated in this study. 2. Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the last 30 days or is currently participating in another study of an IMP or medical device. 3. Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, toxins, metabolic disorders, encephalitis, cerebrovascular disease or degenerative disease). 4. Subject has a history of psychosis or hallucinations within the previous 12 months. 5. Subject has cognitive impairment in the judgment of the Investigator that excludes him/her from understanding consent or participating in the study. 6. Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit. 7. Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit. 8. Subject who has taken anticholinergic drugs for PD or amantadine for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 1 month prior to the baseline visit. 9. Subject who is taking non-selective MAO inhibitors. 10. Subject who is taking potent CYP1A2 inhibitors, e,g, Ciprofloxacin 11. Subject who is taking antitussive agent dextromethorphan. 12. Subject who is taking analgesic agents such as tramadol, meperidine, methadone and propoxyphene. 13. Subject who is taking strong 3A4 inducers, e.g., St. John's Wort or cyclobenzaprine (tricyclic muscle relaxant). 14. Subject who is taking dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide. 15. Subject has a history of alcohol or drug abuse or dependence within the prior 12 months, according to Investigator judgment, (alcohol intake is limited to 1 glass or shot per day during the whole study taken not less than 3 hours before or after dosing (see section 10.2). 16. Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study. 17. Subject has severe renal impairment (creatinine clearance <30 mL/min) or on dialysis. 18. Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment. 19. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) at Screening. 20. Subject has known hypersensitivity or intolerance to pramipexole or rasagiline or to any components or excipients of the test drug or placebo. 21. Subject who has a history of neuroleptic malignant syndrome. 22. Subject who is pregnant or breastfeeding. 23. Subject, who, for any reason, is judged by the Investigator or the eligibility monitoring committee (EMC) to be inappropriate for this study, including a subject who is unable to communicate or cooperate with the Investigator or who has/h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the superiority of P2B 0.6/0.75 mg as compared to its individual components in the change of total UPDRS score (defined as sum of parts II and III, scores (0-160).;Secondary Objective: • To determine 12 weeks the superiority of P2B 0.6/0.75 mg as compared to pramipexole ER in the change of Epworth Sleepiness Scale (ESS) score. • To determine the efficacy of P2B 0.6/0.75 mg as compared to its individual components in the change of Total PDQ39 score. • To determine the efficacy of P2B 0.6/0.75 mg as compared to its individual components in the change of ADL UPDRS (part II) score. • To determine the efficacy of P2B 0.6/0.75 mg as compared to its individual components in the change of motor UPDRS (part III) score. • To determine the efficacy of P2B 0.6/0.75 mg as compared to its individual components in the CGI-S responder’s analysis (change from baseline =1 CGI-S points).;Primary end point(s): Superiority of P2B001 0.6/0.75 mg as compared to its individual components in the change of total UPDRS score.;Timepoint(s) of evaluation of this end point: Week 12/Treatment termination visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 12/Treatment termination visit.;Secondary end point(s): 1. Superiority of P2B001 as compared to pramipexole ER in the change of Epworth Sleepiness Scale (ESS) score. 2. Efficacy of P2B001 as compared to its individual components in the change of Total PDQ39 score. 3. Efficacy of P2B001 as compared to its individual components in the change of ADL UPDRS (part II) score. 4. Efficacy of P2B001 as compared to its individual components in the change of motor UPDRS (part III) score. 5. Efficacy of P2B001 as compared to its individual components in the CGI-S responder’s analysis (change from baseline =1 CGI-S points). | — |
Countries
Canada, France, Germany, Spain, United States
Contacts
Public ContactHadas Friedmann
Pharma Two B Ltd
Outcome results
None listed