Low-Dose Carbon Monoxide for Parkinson's Disease
(LoCaMoTE-PD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for Parkinson's disease using a low-dose carbon monoxide liquid called HBI-002. The study aims to determine the safety of HBI-002 and its movement through the body when taken daily for 14 days. Participants will be divided into groups receiving either a low dose, high dose, or placebo (a substance with no active drug) to compare effects. Suitable candidates include those diagnosed with Parkinson's disease within the past five years, who respond well to levodopa (a common PD medication), and who are non-smokers with no smoking in the home. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of potentially effective therapies.
Do I have to stop taking my current medications for the trial?
The trial does not specify that you need to stop taking your current medications. In fact, it requires that you continue using your Parkinson's medication, like levodopa, at a stable dose for at least 30 days before joining the study.
Is there any evidence suggesting that HBI-002 is likely to be safe for humans?
Research has shown that low-dose carbon monoxide (CO) treatments like HBI-002 are generally safe and well-tolerated. In animal studies, HBI-002 showed promise in protecting brain cells from damage in models of Parkinson's disease. Tests in healthy volunteers also indicated that HBI-002 is safe, as it only slightly increased a marker called carboxy-hemoglobin, which remains within safe limits.
In both low and high doses of HBI-002, past studies reported no serious side effects. This suggests that, at the doses tested, HBI-002 may not cause harmful reactions. However, these findings are based on earlier studies, and ongoing research will provide more detailed safety information.12345Why do researchers think this study treatment might be promising for Parkinson's disease?
Researchers are excited about HBI-002 for Parkinson's disease because it introduces a novel approach by using low-dose carbon monoxide, which is quite different from standard treatments like levodopa or dopamine agonists. Unlike traditional therapies that primarily aim to replenish or mimic dopamine, HBI-002 targets cellular stress and inflammation, potentially offering neuroprotective benefits. This unique mechanism could slow disease progression, addressing the underlying pathology rather than just managing symptoms.
What evidence suggests that HBI-002 might be an effective treatment for Parkinson's disease?
This trial will evaluate the effects of low-dose carbon monoxide (CO) on Parkinson's disease. Studies have shown that small amounts of CO can protect brain cells in people with Parkinson's disease. In animal studies, this treatment prevented the loss of brain cells that produce dopamine, a chemical important for controlling movement. Research also shows that low-dose CO can reduce the buildup of harmful proteins linked to Parkinson's. These findings suggest that low-dose CO might slow the disease and improve symptoms. Although more research is needed in humans, current evidence is promising for those considering this treatment. Participants in this trial will receive either a low dose, a high dose, or a placebo to assess the treatment's effectiveness and safety.13678
Are You a Good Fit for This Trial?
This trial is for people aged 40-80 who have been diagnosed with Parkinson's disease within the last 5 years, are non-smokers (and don't live with smokers), have a good response to levodopa, and meet certain weight and medication stability requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HBI-002 or placebo daily for 14 days to evaluate safety, tolerability, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HBI-002
Trial Overview
The study tests a daily oral low-dose carbon monoxide liquid drug (HBI-002) versus placebo over 14 days in people with Parkinson's. Participants are randomly assigned to either group, and neither they nor their doctors know which treatment they're getting.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hillhurst Biopharmaceuticals, Inc.
Lead Sponsor
The Parkinson Study Group
Collaborator
Citations
Neuroprotection of low dose carbon monoxide in Parkinson's ...
Using rodent models of PD based on α-synuclein (αSyn) accumulation and oxidative stress, we show that low-dose CO mitigates neurodegeneration and reduces αSyn ...
Low-dose carbon monoxide is neuroprotective in rodent ...
In MPTP-exposed mice, low-dose iCO reduced loss of dopamine and TH+ neurons. In saline-treated mice, iCO had no effect on striatal dopamine ...
3.
michaeljfox.org
michaeljfox.org/grant/assessing-potential-low-dose-carbon-monoxide-therapy-parkinsons-diseaseAssessing the Potential of Low-Dose Carbon Monoxide ...
Together with preliminary data showing that low-dose carbon monoxide reduces the death of dopamine-producing neurons and the accumulation of alpha-synuclein ...
4.
parkinsonsnewstoday.com
parkinsonsnewstoday.com/news/low-dose-carbon-monoxide-may-protect-neurons-with-parkinsons/Low-dose carbon monoxide may protect neurons with ...
“Low-dose CO treatment increased the survival of dopaminergic neurons in a progressive model of [Parkinson's] neurodegeneration,” the ...
Neuroprotection of low dose carbon monoxide in Parkinson's ...
Neuroprotection of low dose carbon monoxide in Parkinson's disease models commensurate with the reduced risk of Parkinson's among smokers.
Phase 2a Clinical Study of HBI-002 in Parkinson's Disease
Study Rationale: A growing body of research suggests that low doses of carbon monoxide (CO) protect against neuronal cell loss in Parkinson's disease (PD).
Low Dose Carbon Monoxide Is Neuroprotective in Models ...
Each HBI-002 treatment increased carboxy-hemoglobin to 6%. In the aSyn model, treatment with HBI-002 reduced ipsilateral loss of both striatal dopamine and TH- ...
A Study to Assess the Safety and Pharmacokinetics of HBI- ...
A Study to Assess the Safety and Pharmacokinetics of HBI-002, an Oral Carbon Monoxide Therapeutic, in Healthy Volunteers. ClinicalTrials.gov ID NCT03926819.
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