EUCTR2017-000262-30-IT
Active, not recruiting
Phase 1
Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations - NA
ConditionsParkinson's Desease (PD)MedDRA version: 21.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsSinemet
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Parkinson's Desease (PD)
- Sponsor
- DR. REDDY’S LABORATORIES LIMITED
- Enrollment
- 18
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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