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 range18 Years – 80 Years
SexALL
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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.
✓. Able to understand the study procedures and requirements, willing to comply with the clinical trial protocol, and voluntarily sign written informed consent.
Exclusion criteria
✕
What they're measuring
1
Change from Baseline in Average Daily Pain Score (ADPS) at Weeks 12.
. 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;