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

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ClinicalTrials.gov Identifier: NCT04369430
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Alkahest, Inc.

Tracking Information
First Submitted Date  ICMJE April 13, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date May 12, 2021
Actual Study Start Date  ICMJE January 16, 2020
Actual Primary Completion Date April 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
Change in motor function during levodopa withdrawal. [ Time Frame: Baseline to 12 weeks ]
Change from Baseline in motor function during the practically defined off-medication state, defined as at least 12 hours off levodopa, at Week 12 as measured by Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 Motor Examination (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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • Safety as assessed by the incidence, seriousness and severity of adverse events (AEs). [ Time Frame: Baseline to 14 weeks ]
    Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) identified by the Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) and grouped by MedDRA System Organ Class (SOC).
  • Evaluation of laboratory changes. [ Time Frame: Baseline to week 12 ]
    Incidence of abnormalities or clinically-significant changes from Baseline in laboratory test data (chemistry, hematology, and urinalysis).
  • Evaluation of Vital Sign changes. [ Time Frame: Baseline to week 12 ]
    Incidence of abnormalities or clinically-significant changes from Baseline in Vital sign measurements (blood pressure as measured in mmHg, heartrate as measured in beats per minute, and temperature as measured in degrees Fahrenheit or Celsius).
  • Evaluation of Electrocardiogram changes. [ Time Frame: Baseline to week 12 ]
    Incidence of abnormalities or clinically-significant changes from Baseline in 12-lead electrocardiogram (ECG) QT-interval.
  • The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts 1-4, change from baseline during the on-medication state. [ Time Frame: Baseline to week 12 ]
    Part I, Non-Motor Aspects of Experiences of Daily Living (13 items); Part II, Motor Aspects of Experiences of Daily Living (13 items); Part III, Motor Examination (33 items); and Part IV, Motor Complications (6 items). 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 maximum total MDS-UPDRS score is 272, indicating the worst possible disability from Parkinson's Disease.
  • The Montreal Cognitive Assessment (MoCA), change from baseline in MoCA during the on-medication state. [ Time Frame: Baseline to week 12 ]
    The Montreal Cognitive Assessment (MoCA) is a neuropsychological tool that requires approximately 15 minutes to assess the following domains: attention, executive function, memory, language, visuoconstructional skills, and orientation. MoCA scores range between 0 and 30, with higher scores indicating more intact cognition.
  • The Schwab and England Activities of Daily Living (SE-ADL) Scale, change from baseline in SE-ADL during the on-medication state. [ Time Frame: Baseline to week 12 ]
    The SE-ADL evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100% indicates completely independent, 0% indicates bedridden with impaired vegetative functions), so that the lower the score, the worse the functional status. The assessment is conducted by a trained clinician.
  • The Clinical Impression of Severity Index - PD (CISI-PD), change from baseline in CISI-PD during the on-medication state. [ Time Frame: Baseline to week 12 ]
    The CISI-PD is a severity index formed by four items (motor signs, disability, motor complications, and cognitive status), rated 0 (not at all) to 6 (very severe or completely disabled).
  • The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39), change from baseline in PDQ-39 during the on-medication state. [ Time Frame: Baseline to week 12 ]
    The PDQ-39 is a patient-reported outcome of 39 questions relating to 8 key areas of health and daily activities, including both motor and non-motor symptoms. The eight dimensions include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. It is scored on a scale of 0-100 with lower scores indicating better health and high scores indicating more severe symptoms.
  • The Sheehan-Suicidality Tracking Scale (S-STS), change from baseline in S-STS during the on-medication state. [ Time Frame: Baseline to week 12 ]
    The standard version of the S-STS is a 16-item scale that assesses the seriousness of suicidality phenomena on a Likert-type scale (0-4) ranging from "not at all" (0) to "extremely" (4), where higher scores indicate more risk of suicidality.
  • 10-meter timed walk. [ Time Frame: Baseline to week 12 ]
    Change from baseline in a 10-meter timed walk during the on-medication state and the off-medication state.
  • The Hauser 3-Day Patient Diary, change from baseline in the Hauser 3-Day Patient Diary during the on-medication state. [ Time Frame: Baseline to week 12 ]
    The Hauser Patient Diary was developed to assess functional status over a period of time in patients with motor fluctuations and dyskinesia. The diary is designed to record patient motor state for half-hour intervals over a 24-hour period.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: AKST4290
    Oral AKST4290
  • Drug: Placebo
    Oral Placebo
Study Arms  ICMJE
  • Experimental: AKST4290
    Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks.
    Intervention: Drug: AKST4290
  • Placebo Comparator: Placebo
    Subjects will receive placebo, twice daily, for 12 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2021)
110
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2020)
120
Actual Study Completion Date  ICMJE April 8, 2021
Actual Primary Completion Date April 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia,   Germany,   Poland,   Slovakia,   United States
Removed Location Countries Hungary
 
Administrative Information
NCT Number  ICMJE NCT04369430
Other Study ID Numbers  ICMJE AKST4290-211
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alkahest, Inc.
Study Sponsor  ICMJE Alkahest, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alkahest, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP