Clinical trial NCT04369430: Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Parkinson's Disease
Dementia
Movement Disorder
Shaking Palsy
Lead sponsor: Alkahest, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-30
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: Key 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 ≤2.5.
* 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 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.

Primary outcomes:
measure: Change in Motor Function During Levodopa Withdrawal.
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Safety as Assessed by the Incidence, Seriousness and Severity of Adverse Events (AEs).
timeFrame: Baseline to week 14
measure: Evaluation of Laboratory Changes.
timeFrame: Baseline to week 14
measure: Evaluation of Vital Sign Changes.
timeFrame: Baseline to week 12
measure: Evaluation of Electrocardiogram Changes.
timeFrame: Baseline to week 12
measure: The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts 1-4, Change From Baseline During the On-medication State.
timeFrame: Baseline to week 12
measure: The Montreal Cognitive Assessment (MoCA), Change From Baseline in MoCA During the On-medication State.
timeFrame: Baseline to week 12
measure: The Schwab and England Activities of Daily Living (SE-ADL) Scale, Change From Baseline in SE-ADL During the On-medication State.
timeFrame: Baseline to week 12
measure: The Clinical Impression of Severity Index - PD (CISI-PD), Change From Baseline in CISI-PD During the On-medication State.
timeFrame: Baseline to week 12
measure: The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39), Change From Baseline in PDQ-39 During the On-medication State.
timeFrame: Baseline to week 12
measure: The Sheehan-Suicidality Tracking Scale (S-STS), Change From Baseline in S-STS During the On-medication State.
timeFrame: Baseline to week 12
measure: 10-meter Timed Walk, Change in Baseline 10-meter Timed Walk During the on and Off-medication State
timeFrame: Baseline to week 12
measure: 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
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: West Bloomfield
country: United States
facility: Henry Ford Hospital West Bloomfield
state: Michigan
city: Tulsa
country: United States
facility: Movement Disorder Clinic of Oklahoma PLLC
state: Oklahoma
city: Tallinn
country: Estonia
facility: AS Ida-Tallinna Keskhaigla / East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: Astra Kliinik / Astra Team Clinic
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden
city: Hausham
country: Germany
facility: Krankenhaus Agatharied GmbH
city: Kassel
country: Germany
facility: Paracelsus-Elena-Klinik Kassel
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Marburg
country: Germany
facility: UKGM Marburg
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Częstochowa
country: Poland
facility: Centrum Medyczne PRATIA/ Medical Center PRATIA
city: Kraków
country: Poland
facility: Krakowska Akademia Neurologii/ Cracow Academy of Neurology
city: Oświęcim
country: Poland
facility: Instytut Zdrowia Dr Boczarska-Jedynak Spolka Z Oraganiczona Odpowiedzialnoscia Spolka Komandytowa/ Institute of Health dr Boczarska-Jedynak
city: Oświęcim
country: Poland
facility: Medicome SP. ZO. O./ Medicome
city: Plewiska
country: Poland
facility: Neurologiczny Nzoz Centrum Leczenia Sm Osrodek Badan Klinicznych
city: Bratislava
country: Slovakia
facility: Euro-Neuro, s.r.o., Neurologická ambulancia
city: Bratislava
country: Slovakia
facility: Nemocnica Kramáre II. Neurologická klinika LF UK a UNB /2nd Dept. Of Neurology, Comenius University Faculty of Medicine and University Hospital Bratislava
city: Galanta
country: Slovakia
facility: Nemocnica s poliklinikou Sv. Lukáša Galanta, a. s Neurologické oddelenie /Neurology Dpt., NsP Galanta
city: Martin
country: Slovakia
facility: Univerzitná nemocnica Martin Neurologická klinika/University hospital Martin, Clinic of Neurology
Study officials:
affiliation: Alkahest, Inc.
name: Alkahest Medical Monitor
role: STUDY_DIRECTOR
References: