AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia (NCT04147949) | Clinical Trial Compass
UnknownPhase 2
AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
20 participantsStarted 2022-08
Plain-language summary
This is a randomized, double-blind, placebo-controlled, crossover, proof-of-concept Phase 2 study to test efficacy and safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease subjects with levodopa-induced dyskinesia. The trial will be conducted in two treatment periods, in which each treatment period will consist of 14 days. The two treatment periods will be separated by a 1-week washout period. During the first treatment period, subjects meeting all eligibility criteria will be randomly assigned to receive either 1440 mg AV-101 or placebo in a 1:1 ratio. AV-101 or placebo will be administered BID for 14 days (every 12 hours). After the washout period, all subjects will be crossed over to receive the alternate treatment during the second treatment period (14-day period).
On the last day of each treatment period (Visit 4 \[Day 14\] and Visit 7 \[Day35\]), subjects will be assessed in clinic while in the practically "off" state and will receive the morning dose of the study drug at the clinic. This will be followed, within 25-30 minutes, by oral administration of a dose of levodopa that is 150% of the subject's normal dose. Assessments of dyskinesia and PD motor symptoms will be performed before and after levodopa/carbidopa administration.
Who can participate
Age range
30 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female adults, 30 to 80 years of age, inclusive.
. Diagnosis of idiopathic PD meeting the United Kingdom Parkinson's disease Society Brain Bank criteria.
. Levodopa-induced dyskinesia present greater than 25% of the day as per MDS-UPDRS.
. Dyskinesia of at least moderate severity as per MDS-UPDRS
. Subjects currently receiving anti-parkinsonian medications that contain levodopa and carbidopa are eligible provided they have been on a stable dose of these medications for at least 1 month prior to randomization.
. Subjects currently receiving antidepressants such as selective serotonin reuptake inhibitors, provided the dose has been stable for at least 1 month prior to randomization.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. If female, a status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:
. Non-childbearing potential (e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or is postmenopausal with her last menses at least 1 year prior to screening); or
Exclusion criteria
. Women with childbearing potential who are not willing to use one of the specified forms of birth control during the study or whose partner is unwilling to use a condom.
. Women who are pregnant or breastfeeding.
. Women with a positive pregnancy test at screening or baseline.
. Currently taking a prohibited adjunct therapy such amantadine or monoamine oxidase (MAO) inhibitors must be discontinued at least 3 weeks prior to baseline.
. Subject had a prior surgery for PD except Deep Brain Stimulation (Deep Brain Stimulation must not have been performed within one year of screening)
. Hoehn and Yahr score of 5 when "off".
. Subject with Cognitive impairment and/or history of psychiatric manifestations or active hallucinations.
. History of positive screening urine test for drugs of abuse at screening: cannabinoids (if the subject has a legitimate medical prescription for cannabis, subject must agree to abstain during the entirety of the study and to have a negative test at baseline), cocaine, barbiturates, opiates. A positive benzodiazepine result will be allowed if there is a valid and prescribed medical use for these agents. For all other positive results, a single re-test is permitted at the judgement of the investigator; results of any retest must be available prior to the baseline visit and must be negative.