Status:
COMPLETED
Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
Lead Sponsor:
Alkahest, Inc.
Conditions:
Parkinson Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of AKST4290 in subjects with Parkinson's Disease who are currently on stable dopaminergic treatment.
Eligibility Criteria
Inclusion
- Key
- Diagnosis of clinically established or clinically probable PD according to MDS-PD criteria with at least 1 year of PD symptoms.
- Modified Hoehn and Yahr ≤2.5.
- Have notable motor worsening during off-medication state.
- Clear-cut improvement of motor response to levodopa medications, as assessed by the investigator.
- Must be on stable dopaminergic therapy (e.g., levodopa, dopamine agonists, monoamine oxidase inhibitors, catechol-O-methyl transferase inhibitors, amantadine), for at least 8 weeks prior to enrollment and remain on stable dose during the 12-week treatment period.
- Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening. WOCBP must agree to use highly effective contraception prior to study entry. Male subjects must be willing to use a barrier method of contraception.
- Key
Exclusion
- Secondary or atypical parkinsonian syndromes, for example, patients with parkinsonism from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive supranuclear palsy, Lewy body dementia.
- History of any brain surgery for PD (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplant).
- Conditions affecting the peripheral or central nervous system, unless related to PD, that would affect the ability to adequately perform the MDS-UPDRS and motor assessments: i.e., severe sensory neuropathy affecting arm or leg function, or stroke affecting motor or gait function.
- Significant alcohol or drug abuse within past 2 years.
- Based on ECG reading, subjects with a risk of QT prolongation.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
January 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04369430
Start Date
January 16 2020
End Date
March 10 2021
Last Update
October 10 2022
Active Locations (22)
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1
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
2
Henry Ford Hospital West Bloomfield
West Bloomfield, Michigan, United States, 48322
3
Movement Disorder Clinic of Oklahoma PLLC
Tulsa, Oklahoma, United States, 74136
4
AS Ida-Tallinna Keskhaigla / East Tallinn Central Hospital
Tallinn, Estonia