RELIEF-PD: Crisugabalin for Nociplastic Pain in Parkinson's Disease (NCT07483398) | Clinical Trial Compass
Active — Not RecruitingPhase 4
RELIEF-PD: Crisugabalin for Nociplastic Pain in Parkinson's Disease
China166 participantsStarted 2026-03-13
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy and safety of Crisugabalin in adult participants with Parkinson's disease suffering from nociceptive pain. The main question it aims to answer is:
1. Does Crisugabalin significantly reduce pain intensity compared to placebo?
2. What is the safety and tolerability profile of Crisugabalin in patients with Parkinson's disease?
Researchers will compare participants receiving Crisugabalin to those receiving a matching placebo to see if the investigational drug leads to a greater reduction in pain scores and an improvement in quality of life without unacceptable side effects.
Participants will:
1. Be randomly assigned to receive either Crisugabalin capsules or a placebo.
2. Take the study medication orally twice daily for a specified treatment period.
3. Complete regular pain assessments using standardized scales (e.g., VAS or NRS).
4. Undergo physical examinations and laboratory tests to monitor safety.
5. Record any adverse events and changes in Parkinson's disease symptoms in a diary.
Who can participate
Age range
18 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
. Age 18-80 years (including 18 years), male or female.
. Diagnosis of Parkinson's disease (PD) according to the diagnostic criteria established by the International Parkinson and Movement Disorder Society (MDS), including clinically established or clinically probable PD, with diagnosis made at least 6 months prior to screening.
. Patients with nociplastic pain according to the classification of chronic pain in Parkinson's disease defined by the International Association for the Study of Pain (IASP).
. Chronic pain associated with Parkinson's disease has been stable for at least 3 months prior to screening.
. Stable anti-Parkinsonian medication regimen for at least 1 month prior to screening.
. Average Daily Pain Score (ADPS) ≥4 during the week prior to screening.
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.
What they're measuring
1
Change from Baseline in Average Daily Pain Score (ADPS) at Weeks 12.
. Able to understand the study procedures and requirements, willing to comply with the clinical trial protocol, and voluntarily sign written informed consent.
Exclusion criteria
. Severe Parkinson's disease defined as stage 5 on the Hoehn and Yahr Scale at screening (wheelchair-bound or bedridden unless aided).
. Severe cognitive impairment or dementia defined as Mini-Mental State Examination (MMSE) score ≤24.
. Presence of severe pain unrelated to Parkinson's disease.
. Presence of neurological disorders unrelated to Parkinson's disease.
. History of severe psychiatric disorders within 1 year prior to screening.
. Presence of chronic systemic diseases that, in the investigator's opinion, may affect participation in the study, including but not limited to:
. Hematology: neutrophils \<1.5 × 10⁹/L, or platelets \<90 × 10⁹/L, or hemoglobin \<100 g/L;
. Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × the upper limit of normal (ULN), or total bilirubin (TBIL) \>1.5 × ULN;