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

NCT07483398 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: KY2025-1335-04
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does Crisugabalin significantly reduce pain intensity compared to placebo?
2. 2.What is the safety and tolerability profile of Crisugabalin in patients with Parkinson's disease?
3. 3.Be randomly assigned to receive either Crisugabalin capsules or a placebo.
4. 4.Take the study medication orally twice daily for a specified treatment period.
5. 5.Complete regular pain assessments using standardized scales (e.g., VAS or NRS).
6. 6.Undergo physical examinations and laboratory tests to monitor safety.
7. 7.Record any adverse events and changes in Parkinson's disease symptoms in a diary.

Conditions

Parkinson's Disease With Nociceptive Pain

Keywords

Parkinson's disease; nociceptive pain; crisugabalin

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Average Daily Pain Score (ADPS) at Weeks 12.

  Change from baseline in the average daily pain score (ADPS) assessed at Week 12 of treatment.

  Baseline to Weeks 12

Secondary Outcomes (5)

• Change from Baseline in Average Daily Pain Score (ADPS) at Weeks 2, 4, and 8

  Baseline to Weeks 2, 4, and 8

• Change from Baseline in King's Parkinson's Disease Pain Scale (KPPS) Score at Weeks 2, 4, 8, and 12

  Baseline to Weeks 2, 4, 8, and 12

• Change from Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 2, 4, 8, and 12

  Baseline to Weeks 2, 4, 8, and 12

• ADPS Responder Rate at Week 12

  Week 12

• Patient Global Impression of Change (PGIC) for Numbness, Pain, and Paresthesia at Week 12

  Week 12

Study Arms (2)

Crisugabalin group

EXPERIMENTAL

Participants will receive oral Crisugabalin capsules twice daily (BID) for 12 weeks. Initial dose: 20 mg BID; may escalate to 40 mg BID based on tolerability.

Drug: Crisugabalin

Placebo Comparator

PLACEBO COMPARATOR

Participants in this arm will receive oral placebo capsules twice daily (BID) for 12 weeks. Placebo capsules are identical in appearance, taste, and packaging to active Crisugabalin. All safety and efficacy assessments follow the same schedule as the experimental group.

Drug: Placebo

Interventions

Crisugabalin DRUG

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.

Crisugabalin group

Placebo DRUG

Placebo is in distinguishable from active crisugabalin in appearance and administration.

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• (1) Severe cardiopulmonary diseases, such as unstable angina, myocardial infarction, severe arrhythmia, heart failure classified as WHO functional class III-IV, poorly controlled hypertension despite treatment (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg at screening), or recurrent asthma attacks; (2) Neurological or psychiatric disorders including epilepsy, recurrent dizziness or headache, memory impairment, or cognitive disorders.
• \. Severe hematologic, hepatic, or renal dysfunction meeting any of the following laboratory criteria:
• 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;
• Renal function: estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² (calculated using the simplified MDRD equation) or patients receiving renal dialysis;
• Creatine kinase (CK) \>2 × ULN. 8. Use of crisugabalin, mirogabalin, pregabalin, or gabapentin within 28 days prior to screening, unless a washout period of at least 1 month has been completed.
• \. Use of strong opioid medications for the treatment of Parkinson's disease-related pain within 3 months prior to screening.
• \. Prior treatment with pregabalin ≥300 mg/day or gabapentin ≥1200 mg/day with lack of clinical efficacy, as judged by the investigator.
• \. Known allergy or hypersensitivity to the investigational drug, rescue medication components, or other structurally related compounds or excipients.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Sichuan Haisco Pharmaceutical Group Co., Ltd: collaborator

Study Sites (1)

No. 106 Zhongshan Er Road

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Parkinson Disease; Nociceptive Pain

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication of the primary manuscript and continuing for 5 years.
• Access Criteria: De-identified individual participant data, along with the study protocol, statistical analysis plan, and informed consent form, will be available to qualified researchers who submit a scientifically sound proposal approved by an independent data access committee. Data will be provided via a secure online platform upon execution of a data use agreement.

Locations

CN (1)