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

NCT04369430 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AKST4290-211
• Study Type: interventional
• Target: 110
• Locations: 5 countries
• Sites: 22

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

Keywords

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinson's Disease; Dementia; Movement Disorder; Shaking Palsy

Outcome Measures

Primary Outcomes (1)

• Change in Motor Function During Levodopa Withdrawal.

  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.

  Baseline to 12 weeks

Secondary Outcomes (12)

• Safety as Assessed by the Incidence, Seriousness and Severity of Adverse Events (AEs).

  Baseline to week 14

• Evaluation of Laboratory Changes.

  Baseline to week 14

• Evaluation of Vital Sign Changes.

  Baseline to week 12

• Evaluation of Electrocardiogram Changes.

  Baseline to week 12

• 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

Study Arms (2)

AKST4290

EXPERIMENTAL

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

Drug: AKST4290

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AKST4290 DRUG

Oral AKST4290

AKST4290

Placebo DRUG

Oral Placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alkahest, Inc.: lead

Study Sites (22)

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Henry Ford Hospital West Bloomfield

West Bloomfield, Michigan, 48322, United States

Location

Movement Disorder Clinic of Oklahoma PLLC

Tulsa, Oklahoma, 74136, United States

Location

AS Ida-Tallinna Keskhaigla / East Tallinn Central Hospital

Tallinn, Estonia

Location

Astra Kliinik / Astra Team Clinic

Tallinn, Estonia

Location

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

Location

Krankenhaus Agatharied GmbH

Hausham, Germany

Location

Paracelsus-Elena-Klinik Kassel

Kassel, Germany

Location

Universitatsklinikum Leipzig

Leipzig, Germany

Location

UKGM Marburg

Marburg, Germany

Location

Klinikum rechts der Isar der Technischen Universität München

München, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Centrum Medyczne PRATIA/ Medical Center PRATIA

Częstochowa, Poland

Location

Krakowska Akademia Neurologii/ Cracow Academy of Neurology

Krakow, Poland

Location

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

Oświęcim, Poland

Location

Medicome SP. ZO. O./ Medicome

Oświęcim, Poland

Location

Neurologiczny Nzoz Centrum Leczenia Sm Osrodek Badan Klinicznych

Plewiska, Poland

Location

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

Bratislava, Slovakia

Location

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

Bratislava, Slovakia

Location

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

Galanta, Slovakia

Location

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

Martin, Slovakia

Location

MeSH Terms

Conditions

Parkinson Disease; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dementia; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies

Results Point of Contact

• Title: Clinical Development
• Organization: Alkahest, Inc.

trials@alkahest.com

(650) 801-0474

Study Officials

• Alkahest Medical Monitor

  Alkahest, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 30, 2020
• Study Start: January 16, 2020
• Primary Completion: February 11, 2021
• Study Completion: March 10, 2021
• Last Updated: October 10, 2022
• Results First Posted: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); PL (5); DE (8); ES (2); SL (4)