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EFficacy and safEty of cRisugabalin on nocipLastic paIn in Patients With Parkinson's Disease (RELIEF-PD): a Multicentre, Double-blind, Randomised Controlled Trial

Study acronym: RELIEF-PD
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Study title expanded, about 12 wordsv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07483398
Lead Sponsor Guangdong Provincial People's Hospital
Collaborators: Sichuan Haisco Pharmaceutical Group Co., Ltd
Conditions
(from sponsor)		 PARKINSON DISEASE (Disorder)
Related terms Nociceptive Pain, Parkinson Disease
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov