A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment

Alkahest, Inc.22 sites in 5 countries110 target enrollmentJanuary 16, 2020

ConditionsParkinson Disease

InterventionsAKST4290 Placebo

Overview

Phase: Phase 2
Intervention: AKST4290
Conditions: Parkinson Disease
Sponsor: Alkahest, Inc.
Enrollment: 110
Locations: 22
Primary Endpoint: Change in Motor Function During Levodopa Withdrawal.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 16, 2020

End Date

March 10, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alkahest, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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.

Exclusion Criteria

•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.

Arms & Interventions

AKST4290

Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks.

Intervention: AKST4290

Placebo

Subjects will receive placebo, twice daily, for 12 weeks.

Intervention: Placebo

Outcomes

Primary Outcomes

Change in Motor Function During Levodopa Withdrawal.

Time Frame: Baseline to 12 weeks

Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 Motor Examination has 33 scores based on 18 questions with several right, left, or both body distribution scores. Each Parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The minimum score on the MDS-UPDRS Part 3 is 0 and the maximum is 132. Outcome is the mean change from Baseline in motor function during the practically defined off-medication state, defined as at least 12 hours off levodopa, at Week 12, with lower score representing better outcome.

Secondary Outcomes

Safety as Assessed by the Incidence, Seriousness and Severity of Adverse Events (AEs).(Baseline to week 14)
The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts 1-4, Change From Baseline During the On-medication State.(Baseline to week 12)
Evaluation of Laboratory Changes.(Baseline to week 14)
Evaluation of Electrocardiogram Changes.(Baseline to week 12)
Evaluation of Vital Sign Changes.(Baseline to week 12)
The Montreal Cognitive Assessment (MoCA), Change From Baseline in MoCA During the On-medication State.(Baseline to week 12)
The Schwab and England Activities of Daily Living (SE-ADL) Scale, Change From Baseline in SE-ADL During the On-medication State.(Baseline to week 12)
10-meter Timed Walk, Change in Baseline 10-meter Timed Walk During the on and Off-medication State(Baseline to week 12)
Hauser 3-Day Patient Diary, Change in Baseline Mean Time Spent With and Without Troublesome Dyskinesia as Measured by the Hauser 3-Day Patient Diary(Baseline to week 12)
The Clinical Impression of Severity Index - PD (CISI-PD), Change From Baseline in CISI-PD During the On-medication State.(Baseline to week 12)
The Sheehan-Suicidality Tracking Scale (S-STS), Change From Baseline in S-STS During the On-medication State.(Baseline to week 12)
The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39), Change From Baseline in PDQ-39 During the On-medication State.(Baseline to week 12)