None listed
Conditions
Brief summary
The PROTECT-PD Study is a randomised, double-blind, placebo-controlled study designed to assess the efficacy, safety and tolerability of Probucol (Lorelco™) in individuals with early to moderate Parkinson’s disease (PD). The trial will investigate whether Probucol can slow disease progression while maintaining an acceptable safety profile in approximately 140 participants. If you are eligible and choose to take part, you will be randomly assigned to receive either Probucol (Lorelco™) or a placebo (an inactive capsule). You will take two capsules each day, one in the morning and one at night. Your participation will last up to 82 weeks (about 19 months), including up to 8 weeks of screening, 78 weeks of treatment, and a 4-week follow-up after treatment ends.
Interventions
PROTECT-PD is a randomised controlled research trial examining whether intervention with Probucol supports motor symptom progression within PD. Participants are randomly assigned to one of two groups, group 1 (treatment) or group 2 (placebo).
Group 1 (Treatment):
Chemical name: 4,4’-[Propan-2,2-diylbis(sulfandiyl)]bis[2,6-bis(1,1- dimethylethyl) phenol]
The proposed dose of Probucol for this protocol adopts contemporary usage published in contemporary clinical trials at 250 mg twice a day. Prob
PROTECT-PD is a randomised controlled research trial examining whether intervention with Probucol supports motor symptom progression within PD. Participants are randomly assigned to one of two groups, group 1 (treatment) or group 2 (placebo). Group 1 (Treatment): Chemical name: 4,4’-[Propan-2,2-diylbis(sulfandiyl)]bis[2,6-bis(1,1- dimethylethyl) phenol] The proposed dose of Probucol for this protocol adopts contemporary usage published in contemporary clinical trials at 250 mg twice a day. Probucol will be supplied in a commercially available form known as Lorelco and taken as capsules orally. Study medication will commence (day 1, week 1) with a single dose escalation design with all participants receiving initially for two-weeks 1 X placebo per day (once daily). Unused medication is to be returned at every visit to monitor drug compliance. Subjects will be dosed as: • Placebo lead-in (Weeks 1 and 2): ALL participants (both the treatment group and the placebo group) receive ONE placebo capsule taken orally ONCE DAILY in the morning, with food. No active study drug (Lorelco) is administered during this 2-week lead-in period. This phase acclimatises participants to the dosing schedule before randomised treatment begins. • Week 3: 1 x 250 mg Lorelco™ (or matching placebo) taken orally once daily in the morning, with food. • Week 4 – 78: 1 x 250 mg Lorelco™ (or matching placebo) taken in the morning, with food. 1 x 250 mg Lorelco™ taken in the evening, with food (total dose: 500 mg/day). Unused medication is to be returned at every visit to monitor drug compliance.
Sponsors
Curtin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. Adult males and females, greater than or equal to 40 years or above age at screening Diagnosis of Parkinson’s Disease within three years prior to screening, MDS-UDPRS Part III motor score of between 15 and 35 at screening, assessed in the ON medication state Montreal Cognitive Assessment score of greater than or equal to 26 at screening Stable dose of levodopa, dopamine agonists, or other PD medications for at least 4 weeks prior to screening, with no intention to change the medication regimen during the trial period. This need not prohibit changes in medication if clinically indicated once on trial. Able to take oral medications and willing to record daily adherence to the study drug. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Exclusion criteria
1. Hoehn and Yahr scale score of 3 or more 2. Presence of motor fluctuations of dyskinesia 3. Atypical or secondary parkinsonism. 4. History of significant drug induced QT interval prolongation. 5. Evidence of abnormal cardiac function as defined by any of the following: a. Myocardial infarction within 6 months of Week 1, Day 1 b. Symptomatic congestive heart failure (New York Heart Association > Class II) c. Unstable angina d. Unstable atrial fibrillation including paroxysmal atrial fibrillation. Medicated, stable atrial fibrillation will be assessed on a case-by-case basis e. Frequent multifocal ventricular arrhythmia 6. Gastrointestinal conditions that, in the opinion of the Investigator, could affect the absorption of study drug. 7. Use of the below medications, supplements, or consumption of foods within 7 days of first administration of Probucol (Lorelco™), and for the duration of the study. These include (but are not limited to): a. Strong QT prolongation inducers should be assessed on a case-by-case basis at the discretion of the investigator b. With significant central anticholinergic effects, c. Sedatives, d. Any investigational treatment for PD e. Foods: Grapefruit or Seville orange (or grapefruit- or Seville orange-containing products, including juices) 8. Current diagnosis of cancer (within 3 years) and/or undergoing chemotherapy, with exception to non-melanoma skin cancers such as basal or squamous cell carcimona in situ, 9. Significant head injury within 5 years 10. Electrolyte imbalance (e.g. on high steroids, pituitary tumours and Addison disease) 11. Hypokalaemia, hypomagnesaemia and hypocalcaemia 12. Major surgery is planned during the conduct of the trial, or a clinical event has occurred in the six months preceding study inclusion that may compromise ability to participate for the duration of the study, 13. History of stroke with residual cognitive or motor deficits 14. Current diagnosis with a psychiatric disorder such as major depression, bipolar disorder or schizophrenia where the condition is affecting daily functioning, or taking psychotropic medications 15. Other excluded medications will be those that are specifically contraindicated with Probucol, based on historic clinical indications for the treatment of cardiovascular disease. 16. Self-reported active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBsAg) or hepatitis C virus (HCV). 17. Any inflammatory or chronic pain condition that necessitates regular use of opiates/opioids, 18. Major surgery within 28 days of the pre-baseline visit, or minor surgical procedures within 7 days of pre-baseline . 19. For women of childbearing potential, a hCG pregnancy test > 5 U/L at screening, or on Day 1, prior to dose administration. 20. Pregnant or breast-feeding (or planning to breastfeed) while on study through 15 days after the last dose of study drug. 21. Hypersensitivity or other clinically significant reaction to the study drug or its inactive ingredients. 22. Known substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the patient’s participation in the clinical study or evaluation of the clinical study results.
Outcome results
None listed