IkT-148009 for Parkinson's Disease

Recruiting at 35 trial locations

Overseen By Carl Klint

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ABLi Therapeutics, Inc.

Must not be taking: Antipsychotics, Amphetamines, Levodopa, others

Disqualifiers: Atypical parkinsonism, Hallucinations, Substance abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

120 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

Yes, you will need to stop certain medications to join the trial. You cannot be on any anti-parkinsonian therapy, and you must not have taken certain medications like levodopa or monoamine oxidase-B inhibitors within 28 days before screening. If you've used irreversible monoamine oxidase-B inhibitors, they must be stopped at least 90 days before screening.

What is the purpose of this trial?

This trial tests the safety and effects of IkT-148009, a daily pill, in people aged 30 to 80 with untreated Parkinson's disease. The drug aims to block an enzyme that may help manage symptoms. Participants will take the drug for a few months.

Research Team

Milton Werner, PhD

Principal Investigator

ABLi Therapeutics, Inc.

Eligibility Criteria

This trial is for people aged 30-80 with untreated Parkinson's Disease (PD) who meet specific medical criteria and can self-administer a drug daily with food. They must not need other PD treatments during the study, agree to birth control methods if of childbearing potential, and have no significant health issues that could affect participation.

Inclusion Criteria

I have Parkinson's disease with slow movements and uneven symptoms on both sides.

I am not on any medication for Parkinson's disease.

Montreal Cognitive Assessment ≥ 24

Exclusion Criteria

I have advanced or intermediate age-related vision loss.

I experience significant dizziness when standing up.

I haven't taken Parkinson's disease medications or supplements for over 28 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive one of three doses of IkT-148009 or placebo once daily for 12 weeks

12 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• IkT-148009
• Placebo

Trial Overview The trial tests IkT-148009's safety and how it affects the body compared to a placebo in managing Parkinson's symptoms. Participants will randomly receive either one of three doses of IkT-148009 or a placebo once daily for 12 weeks.

Participant Groups

Group I: 50mg IkT-148009 Experimental Treatment 1 Intervention

This arm will consist of thirty (30) patients on 50mg of active treatment.

Group II: 200mg IkT-148009 Experimental Treatment 1 Intervention

This arm will consist of thirty (30) patients on 200mg of active treatment.

Group III: 100mg IkT-148009 Experimental Treatment 1 Intervention

This arm will consist of thirty (30) patients on 100mg of active treatment.

Group IV: Placebo Placebo Group 1 Intervention

This arm will consist of thirty (30) patients on placebo.

Who Is Running the Clinical Trial?

ABLi Therapeutics, Inc.

Lead Sponsor

Trials

6

Recruited

450+

Inhibikase Therapeutics, Inc.

Lead Sponsor

Trials

6

Recruited

450+