Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations

Phase 1

• Conditions: Parkinson's Desease (PD); MedDRA version: 21.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000262-30-IT
• Lead Sponsor: DR. REDDY’S LABORATORIES LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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

¿ 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified