NCT07483398

RELIEF-PD: Crisugabalin for Nociplastic Pain in Parkinson's Disease

Fficacy and Safety of Crisugabalin on Nociplastic Pain in Patients With Parkinson's Disease (RELIEF-PD): A Multicentre, Double-Blind, Randomised Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease With Nociceptive Pain

Interventions

Type	Name	Description
DRUG	Crisugabalin	Crisugabalin will be administered orally to participants with Parkinson's disease experiencing nociplastic pain. The study uses a double-blind, randomized, placebo-controlled design. Participants will receive a titrated dose of Crisugabalin, starting at 20 mg twice daily and gradually increasing up to a target dose of 40 mg twice daily, based on individual tolerability, over a 4-week titration period. The total treatment duration is 12 weeks. The primary purpose of Crisugabalin administration is to evaluate its efficacy and safety in reducing nociplastic pain in PD patients. Participants will be monitored regularly for adverse events, vital signs, and laboratory parameters throughout the study period.
DRUG	Placebo	Placebo is in distinguishable from active crisugabalin in appearance and administration.

Timeline

• Start date: 2026-03-13
• Primary completion: 2027-08-15
• Completion: 2027-08-15
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: China