HL-1186 Tablet for postherpetic neuralgia: safety and efficacy in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial uses a double-blind, double-dummy design to compare HL-1186 tablets to placebo and to an active pregabalin control in adults with postherpetic neuralgia. Participants are assigned to HL-1186, HL-1186 placebo, pregabalin capsule, or pregabalin capsule placebo in parallel groups to assess safety, efficacy, and pharmacokinetics. The study includes adults who have persistent PHN pain for at least one month after herpes zoster lesions healed. Key safety monitoring and PK analysis are included to characterize the drug’s profile. Conduct is at multiple centers with lead sponsor Shanghai Yidian Pharmaceutical Technology Development Co., Ltd., in collaboration with Peking University First Hospital in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥ 18 years, of either sex.
2. Pain persists for 1 month or more after healing of skin lesions in patients with herpes zoster.
3. Participants fully understand the purpose, characteristics, methods of the trial and possible AEs, voluntarily participate in the trial and sign the ICF, or have their legal guardian sign the ICF on their behalf.

Exclusion Criteria:

1. Participants with any pain other than PHN, or with other diseases that the researcher considers to potentially affect the evaluation of PHN.
2. Participants who may be allergic to the active ingredients or excipients of HL-1186 Tablet, HL-1186 Tablet placebo, pregabalin capsule or pregabalin capsule placebo, have an allergic constitution, or have a history of allergies to ≥ 3 substances.
3. Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with PHN.
4. The baseline NRS collection begins within the 5 half-lives following the last use of the prohibited drug.
5. Participants who have previously used pregabalin with inadequate efficacy or intolerance.
6. Clinically significant abnormalities in the 12-lead electrocardiogram (ECG) during the screening period, or complicated with severe cardiopulmonary diseases, which are deemed unsuitable for inclusion by the researcher.
7. Participants with a history of malignant tumors within 2 years prior to screening.
8. Participants who have undergone major surgery within 8 weeks prior to enrollment or plan to undergo any surgery during the trial period.
9. Participants with positive human immunodeficiency virus antibody, positive syphilis serological test, positive hepatitis B virus surface antigen with hepatitis B virus DNA \> ULN, or positive hepatitis C virus antibody with hepatitis C virus RNA \> ULN.
10. Participants with a history of alcoholism or drug abuse within 2 years before screening.
11. Female participants who are pregnant, breastfeeding (within 1 year after delivery), or with a positive pregnancy test.
12. Participants deemed by the investigator to be unsuitable for participating in this trial for any reason.

Where it's running

• Peking University First Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Renhai Yang
• Email: clinical_trial@hllife.com.cn
• Phone: 021-64311017

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intradermal exosomes, platelet-rich plasma, and steroid injections for post-herpetic neuralgia

  This study will test whether intradermal injections of exosomes, platelet-rich plasma (PRP), or a steroid can lessen long-lasting shingles-related nerve pain in adults.

  Recruiting Zagazig University · Zagazig, Zagazig · NCT07565844

• Comparing Pregabalin and Lacosamide for Pain Relief in Shingles Patients

  This study is testing whether Pregabalin or Lacosamide works better to relieve pain in adults aged 18 to 50 who have post-herpetic neuralgia after shingles.

  Recruiting CMH Kharian Medical College · Kharan, Punjab Province · NCT06969417

• Erector spinae plane block versus transcutaneous radiofrequency for postherpetic neuralgia

  This project will see if erector spinae plane block or transcutaneous radiofrequency works better to reduce pain in adults with postherpetic neuralgia.

  Recruiting Diskapi Teaching and Research Hospital · Ankara · NCT07400640

• Transcutaneous pulsed radiofrequency for postherpetic neuralgia pain

  This study will try a non-invasive pulsed radiofrequency treatment applied through the skin to reduce pain in adults with postherpetic neuralgia who have not responded to standard treatments.

  Recruiting Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Istanbul, Istanbul · NCT07390279

• Venlafaxine to prevent postherpetic neuralgia after shingles

  This study will test whether giving venlafaxine to adults with recent shingles reduces the chance of developing postherpetic neuralgia.

  Recruiting Beijing Tiantan Hospital · Beijing · NCT07361796

• Y-4 for postherpetic neuralgia

  This will test whether Y-4 reduces nerve pain in adults with postherpetic neuralgia compared with pregabalin.

  Recruiting Phase 2 Neurodawn Pharmaceutical Co., Ltd. · Nanjing, Jiangsu · NCT07275762

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.