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

Alkahest

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Placebo; Drug: AKST4290

Study type: Interventional

Funder types: Industry

Identifiers

NCT04369430

AKST4290-211

Details and patient eligibility

About

This study will evaluate the efficacy and safety of AKST4290 in subjects with Parkinson's Disease who are currently on stable dopaminergic treatment.

Enrollment: 110 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

AKST4290

Experimental group

Description:

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

Treatment:

Drug: AKST4290

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo