Phase 2
Completed N=110
Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
Source: ClinicalTrials.gov NCT04369430 ↗Enrolled (actual)
110
Serious AEs
3.7%
Results posted
Oct 2022
Primary outcomePrimary: Change in Motor Function During Levodopa Withdrawal. — -4.210; -5.114 score on a scale
Summary
This study will evaluate the efficacy and safety of AKST4290 in subjects with Parkinson's Disease who are currently on stable dopaminergic treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Motor Function During Levodopa Withdrawal. |
-4.210; -5.114 | — |
| SECONDARY Safety as Assessed by the Incidence, Seriousness and Severity of Adverse Events (AEs). |
12; 17; 6; 9; 1; 0 | — |
| SECONDARY Evaluation of Laboratory Changes. |
18; 12; 2; 1; 0; 0 | — |
| SECONDARY Evaluation of Vital Sign Changes. |
0; 2 | — |
| SECONDARY Evaluation of Electrocardiogram Changes. |
35; 26; 10; 16; 0; 5 | — |
| SECONDARY The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts 1-4, Change From Baseline During the On-medication State. |
-0.412; -0.827; -0.929; 0.023; -1.340; -1.300 | — |
| SECONDARY The Montreal Cognitive Assessment (MoCA), Change From Baseline in MoCA During the On-medication State. |
0.0; -0.2 | — |
| SECONDARY The Schwab and England Activities of Daily Living (SE-ADL) Scale, Change From Baseline in SE-ADL During the On-medication State. |
1.7; 1.7 | — |
| SECONDARY The Clinical Impression of Severity Index - PD (CISI-PD), Change From Baseline in CISI-PD During the On-medication State. |
-0.662; -0.271 | — |
| SECONDARY The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39), Change From Baseline in PDQ-39 During the On-medication State. |
-5.021; -0.744; -5.557; -3.022; -7.299; -4.602 | — |
| SECONDARY The Sheehan-Suicidality Tracking Scale (S-STS), Change From Baseline in S-STS During the On-medication State. |
0.0; 0.0 | — |
| SECONDARY 10-meter Timed Walk, Change in Baseline 10-meter Timed Walk During the on and Off-medication State |
0.091; 0.084; 0.030; 0.041; 0.107; 0.150 | — |
| SECONDARY 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 |
-1.1; -1.3; 1.7; 0.4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04369430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.