Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment

NCT ID: NCT04369430

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-16
• Study Completion Date: 2021-03-10

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AKST4290

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

Group Type: EXPERIMENTAL

AKST4290

Intervention Type: DRUG

Oral AKST4290

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral Placebo

Interventions

AKST4290

Oral AKST4290

Intervention Type: DRUG

Placebo

Oral Placebo

Intervention Type: DRUG

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 ≤2.5.
• 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.

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alkahest, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alkahest Medical Monitor

Role: STUDY_DIRECTOR

Alkahest, Inc.

Locations

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Henry Ford Hospital West Bloomfield

West Bloomfield, Michigan, United States

Movement Disorder Clinic of Oklahoma PLLC

Tulsa, Oklahoma, United States

AS Ida-Tallinna Keskhaigla / East Tallinn Central Hospital

Tallinn, , Estonia

Astra Kliinik / Astra Team Clinic

Tallinn, , Estonia

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, , Germany

Krankenhaus Agatharied GmbH

Hausham, , Germany

Paracelsus-Elena-Klinik Kassel

Kassel, , Germany

Universitatsklinikum Leipzig

Leipzig, , Germany

UKGM Marburg

Marburg, , Germany

Klinikum rechts der Isar der Technischen Universität München

München, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Centrum Medyczne PRATIA/ Medical Center PRATIA

Częstochowa, , Poland

Krakowska Akademia Neurologii/ Cracow Academy of Neurology

Krakow, , Poland

Instytut Zdrowia Dr Boczarska-Jedynak Spolka Z Oraganiczona Odpowiedzialnoscia Spolka Komandytowa/ Institute of Health dr Boczarska-Jedynak

Oświęcim, , Poland

Medicome SP. ZO. O./ Medicome

Oświęcim, , Poland

Neurologiczny Nzoz Centrum Leczenia Sm Osrodek Badan Klinicznych

Plewiska, , Poland

Euro-Neuro, s.r.o., Neurologická ambulancia

Bratislava, , Slovakia

Nemocnica Kramáre II. Neurologická klinika LF UK a UNB /2nd Dept. Of Neurology, Comenius University Faculty of Medicine and University Hospital Bratislava

Bratislava, , Slovakia

Nemocnica s poliklinikou Sv. Lukáša Galanta, a. s Neurologické oddelenie /Neurology Dpt., NsP Galanta

Galanta, , Slovakia

Univerzitná nemocnica Martin Neurologická klinika/University hospital Martin, Clinic of Neurology

Martin, , Slovakia

Countries

United States; Estonia; Germany; Poland; Slovakia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AKST4290-211

Identifier Type: -

Identifier Source: org_study_id