RecruitingPhase 3NCT07207057

Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease: A Multiarm Multi-stage Platform Trial

Edmond J Safra, Accelerating Clinical Trials in Parkinson's Disease (EJS ACT-PD) - a Multi-arm Multi-stage Platform Trial for Potential Disease Modifying Approaches.

Sponsor

University College, London

Enrollment

1,200 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinsons Disease (PD)

Summary

Parkinson's disease (PD) is currently the fastest-growing neurological condition globally. It is projected to affect 172,000 people in the UK by 2030,with the current annual cost to the country being \~£3.6 billion. The disease progressively impairs physical abilities, leading to increased disability, falls, and difficulties with speech, swallowing, mood, thinking, and memory. While existing treatments can alleviate some symptoms, their effectiveness diminishes over time, and they can cause severe side effects. This trial uses a Multi-Arm,Multi-Stage (MAMS) design where multiple treatments are tested simultaneously in separate groups, called "arms." Each treatment is compared against a placebo, a dummy treatment with no active ingredients, to evaluate its effectiveness and safety. Throughout the trial, each treatment undergoes periodic reviews, known as interim analyses, to assess its safety and potential benefits. If a treatment shows promise, it continues in the trial until a final assessment determines its overall effectiveness. Treatments that do not show positive results are discontinued and replaced with new candidates. This approach reduces the number of participants needed to obtain reliable results and is more cost-effective and faster than conducting separate trials for each treatment. The treatments selected for this trial were chosen based on careful consideration of existing evidence regarding their safety and effectiveness. To choose the treatments we want to test, we carefully considered evidence for safety and effectiveness. The trial will start with two treatment arms (telmisartan and terazosin) and one placebo arm, with a third treatment arm added after one year. We can identify new treatments to add to the trial each year. Participants will be followed up for up to 36 months. After an in-person screening visit, all remaining visits at 3 months,6 months and then every 6 months after, for a total of up to 36 months can be completed remotely. The visits will include questionnaires, assessment of Parkinson's symptoms and discussions about any side effects. Participants will informed of trial progress. Results will be shared via the trial website and published in a medical journal.

Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This is a large, multi-arm platform trial testing several different investigational treatments for Parkinson's disease simultaneously. Rather than studying one drug at a time, the platform design allows researchers to efficiently test multiple promising approaches in people already on standard Parkinson's medication, looking for treatments that might slow progression or improve symptoms. **You may be eligible if...** - You have been diagnosed with Parkinson's disease by a qualified neurologist or movement disorders specialist - You were diagnosed at age 30 or older (there is no upper age limit) - You have been taking Parkinson's medication (levodopa or a dopamine agonist) for at least 2 months - You are eligible for at least one of the active treatment arms in the trial - You (if a woman of childbearing potential) have a negative pregnancy test and agree to use effective contraception **You may NOT be eligible if...** - Your diagnosis of Parkinson's disease is uncertain or inconsistent with established diagnostic criteria - You are not eligible for any of the active treatment arms in the study - You cannot attend study visits within the required timeframes - You have conditions that conflict with the specific treatment being tested Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

An over-encapsulated placebo capsule taken once daily to match the treatment arms following a 5-week titration phase.

DRUGTelmisartan

Over-encapsulated telmisartan 40mg per day for 36 months (plus their usual SoC) following a 5-week titration phase. Titration phase for telmisartan: Week 1-3: one 20 mg capsule per day; Week 4-5: one 40 mg capsule per day

DRUGTerazosin (Hytrin)

Over-encapsulated terazosin 5mg per day for 36 months (plus their usual SoC) following a 5-week titration phase. Titration phase for terazosin: Week 1: one 1 mg capsule per day; Week 2: one 2 mg capsule per day; Week 3: one 3 mg capsule per day; Week 4: one 4 mg capsule per day; Week 5: one 5 mg capsule per day