Parkinson's Desease (PD) MedDRA version: 21.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852
Conditions
Interventions
Product Name: EXN-44(LEVODOPA)
Product Code: EXN-44
Pharmaceutical Form: Oral suspension
CAS Number: 59-92-7
Current Sponsor code: na
Concentration unit: mg/ml milligram(s)/millilitre
Concentration ty
Sponsors
DR. REDDY’S LABORATORIES LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of Idiopathic Parkinson’s Disease (according to modified Hoehn and Yahr Criteria Stages I - IV) (may allow stage IV in and “ON” period). ¿ Patients’ receiving stable regimen of levodopa for at least one month before screening with or without concomitant therapy with dopamine agonists, COMT inhibitors, MAO-B inhibitors, or amantadine. ¿ Patient suffering from at least three “OFF” periods on an average per day for last one months (including one in the morning). ¿ Subjects, male and female, aged 40 years or higher. ¿ Provide written informed consent. ¿ Be willing and able to comply with the study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: ¿ Atypical or secondary Parkinsonism. ¿ Lack of response to levodopa. ¿ Any dopamine receptor-blocking agent or non-selective MAO inhibitors. ¿ Dyskinesia disability score > 3 from UPDRS. ¿ Previous stereotactic surgery. ¿ Any participation in a clinical trial in the previous 6 months. ¿ Current or previous (within last 12 months) history of alcohol or substance abuse. ¿ Malignant melanoma or suspicious undiagnosed skin lesion. ¿ Narrow-angle glaucoma. ¿ Hypersensitivity to levodopa. ¿ Myocardial infarction with residual problems, abnormal kidney function, or abnormal liver transaminase values. Contraception requirements (in case of female subjects of child bearing potential): Females must either be postmenopausal with no menses for at least 12 months or surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective method of contraception with a pearl index of <1% up to 1 month after last dose. Contraception methods with low user dependency should preferably be used, in particular when contraception is introduced as a result of participation in this clinical study. Highly effective’ methods of birth control include*: ¿ combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal ¿ progesterone-only hormonal contraception associated with inhibition of ovulation*: o oral o injectable o implantable† ¿ intra-uterine device (IUD)† ¿ intra-uterine hormone releasing system (IUS)† ¿ bilateral tubular occlusion† ¿ vasectomy of sexual partner that was performed at least 90 days prior to Baseline, and has been medically assessed as successful† ¿ sexual abstinence o Note: Sexually inactive female subjects may be enrolled at the investigator’s discretion provided that they are counselled to refrain from heterosexual intercourse for the duration of the study and for one month after the last dose, and understand the possible risks involved in getting pregnant during the study. *Hormonal methods: If on hormonal contraceptives, must have been on the same hormonal contraceptive product for 3 months (90 days) prior to Baseline and continued on same method and dose throughout the duration of the study. If subject had used hormonal birth control and had stopped, this should have occurred more than 6 months prior to Baseline. Female subjects on low dose oral contraceptives (containing =35 µg of ethinyl estradiol or equivalent dose of other estrogens) must use a second form of contraceptive during the study. †Contraception methods that are considered to have low user dependency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate following pharmacodynamic properties of EXN-32 and EXN-44, and compare them with SINEMET¿. ¿ Time to resolution of ¿OFF¿ period following administration of EXN-32 and EXN-44. ¿ Duration of ¿ON¿ period following dosing. ¿ Proportion of patients evaluated to be in the ¿ON¿ state at 05, 15, 30, 60, 90, and 120 minutes after administration of EXN-32, and EXN-44. ¿ UPDRS Part III motor score at 10, 20, 30, 60, 90, and 120 minutes after each dose of study medication in each period. ¿ To estimate the pharmacokinetic profiles of levodopa and carbidopa. ¿ Maximum plasma concentration (Cmax). ¿ Time to reach maximum plasma concentration (Tmax). ¿ Area under the concentration-time curve from time zero to last measured concentration (AUC0-t).;Secondary Objective: - The secondary study objective of the trial are as follows: - Pharmacokinetic / Pharmacodynamic relationship. - Safety and tolerability.;Primary end point(s): Pharmacodynamic / Efficacy endpoints: The following pharmacodynamics endpoints will be evaluated for EXN-32, EXN-44, or SINEMET®: ¿ Time to resolution of “OFF” period following administration of EXN-32 and EXN-44. ¿ Duration of “ON” period following dosing. ¿ UPDRS III scores. Pharmacodynamic assessments: Baseline and at 05, 15, 30, 60, 90, and 120 minutes following each dose, except UPDRS Part III which will be assessed at pre-dose, 10, 20, 30, 60, 90, and 120 minutes after each dose of study treatment. Pharmacokinetic endpoints: The following pharmacokinetic parameters will be calculated for levodopa and carbidopa in plasma: ¿ AUC0-t ¿ Cmax ¿ Tmax;Timepoint(s) of evaluation of this end point: Pharmacodynamic assessments: Baseline and at 05, 15, 30, 60, 90, and 120 minutes following each dose, except UPDRS Part III which will be assessed at pre-dose, 10, 20, 30, 60, 90, and 120 minutes after each dose of study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿ Pharmacokinetic / Pharmacodynamic relationship. Safety endpoints: ¿ Vital Signs (blood pressure [BP], temperature, pulse rate, and respiration rate). ¿ Clinical laboratory tests (hematology, clinical chemistry). ¿ Urine analysis ¿ Adverse events.; ¿ Pharmacokinetic / Pharmacodynamic relationship. Safety endpoints: ¿ Vital Signs (blood pressure [BP], temperature, pulse rate, and respiration rate). ¿ Clinical laboratory tests (hematology, clinical chemistry). ¿ Urine analysis ¿ Adverse events.;Timepoint(s) of evaluation of this end point: screening period: -14 to -1 treatment period: day 1 - day 10 - day 19 follow up: day 27; ¿ Screening Period (Day -14 to -1) ¿ Treatment period (Day 1 to 19) ¿ Follow-up Period (Day 27) | — |
Countries
Italy
Contacts
Public ContactClinical Operation
TFS Trial Form Support
Outcome results
None listed