NCT04647773

Brief Summary

Investigate the efficacy and safety of HSK16149 capsules in Chinese diabetic peripheral neuropathic pain (DPNP) following 13 weeks treatment in comparison to placebo.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
687

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

December 2, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2022

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

November 16, 2020

Last Update Submit

November 30, 2020

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

  • Compare the change from baseline in Average Daily Pain Score（ADPS） between HSK16149 and placebo at week 5.

    The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.

    Baseline and week 5

  • Compare the change from baseline in Average Daily Pain Score （ADPS） between HSK16149 and placebo at week 13.

    The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.

    Baseline and week 13

Secondary Outcomes (11)

  • Compare the response rate between HSK16149 and placebo at week 5 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).

    Baseline and week 5

  • AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 in 5 weeks post treatment.

    From week 1 to week 5

  • Compare the response rate between HSK16149 and placebo at week 13 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).

    Baseline and week 13

  • Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 13.

    From week 1 to week 13

  • Compare the change from baseline in Visual Analog Scale （VAS） between HSK16149 and placebo at week 13.

    Baseline and week 13

  • +6 more secondary outcomes

Study Arms (6)

HSK16149 20mg BID

EXPERIMENTAL
Drug: HSK16149 20mg BID

HSK16149 40mg BID

EXPERIMENTAL
Drug: HSK16149 40mg BID

HSK16149 60mg BID

EXPERIMENTAL
Drug: HSK16149 60mg BID

HSK16149 80mg BID

EXPERIMENTAL
Drug: HSK16149 80mg BID

Pregabalin 150mg BID

ACTIVE COMPARATOR
Drug: Pregabalin 150mg BID

Placebo BID

PLACEBO COMPARATOR
Drug: Placebo BID

Interventions

HSK16149 20mg BIDDRUG

HSK16149 20mg, orally twice a day, treatment period; 13-weeks fixed dose.

HSK16149 20mg BID
HSK16149 40mg BIDDRUG

HSK16149 40mg, orally twice a day, treatment period; 13-weeks fixed dose.

HSK16149 40mg BID
HSK16149 60mg BIDDRUG

HSK16149 60mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.

HSK16149 60mg BID
HSK16149 80mg BIDDRUG

HSK16149 80mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.

HSK16149 80mg BID
Pregabalin 150mg BIDDRUG

Pregabalin 150mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.

Pregabalin 150mg BID
Placebo BIDDRUG

Placebo, orally twice a day, treatment period; 13-weeks fixed dose.

Placebo BID

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent;
  • Males or females aged 18-75 years of age inclusive;
  • Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;
  • HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening;
  • At Screening, pain scale (VAS) of ≥40 mm and \<90 mm.

You may not qualify if:

  • Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP.
  • Skin conditions in the area affected by neurupathy that could alter sensation.
  • Chronic systemic diseases that may affect subjects' participation in the study.
  • Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:
  • Neutrophils \< 1.5 × 10\^9/L, or platelet \< 90 × 10\^9/L, or hemoglobin \< 100 g/L, or
  • AST/ALT \> 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN, or
  • Estimation of glomerular filtration rate (eGFR) \< 60 mL/min / 1.73 m\^2, or
  • Creatine kinase \> 2.0 × ULN.
  • History of substance abuse or alcohol abuse.
  • Acute complications of diabetes in the 6 months prior to screening.
  • Any active infections at screening.
  • HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive.
  • Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3).
  • Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of DPNP.
  • History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (2)

  • Pan T, Ma J, Li Y, Wang K, Jiang C, Zhang Y, Liu J, Du R, Zhang W, Bian F, Zhang F, Wang L, Pang S, Ning T, Wang B, Li Y, Wu X, Zhang K, Tang X, Hu H, Sun X, Li P, Cheng Z, Sun J, Yang J, Wang Y, Gao J, Mao H, Li F, Huang Q, Li Y, Peng Z, Guo X. Rapid Onset of Pain Relief with Crisugabalin in Patients with Diabetic Peripheral Neuropathic Pain: Findings from a Multicenter, Randomized, Double-Blind, Controlled Study. Pain Ther. 2025 Aug;14(4):1311-1329. doi: 10.1007/s40122-025-00745-3. Epub 2025 May 16.

    PMID: 40377855DERIVED

  • Guo X, Zhang T, Yuan G, Zeng W, Hu Q, Ma J, Li Y, Li H, Zhang Y, Liu J, Bian F, Zhang W, Zhang F, Pang S, Li Y, Wu X, Tang X, Zhang K, Pan T, Hu H, Cheng Z, Wang Y, Gao J, Sun J. GABA Analogue HSK16149 in Chinese Patients With Diabetic Peripheral Neuropathic Pain: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425614. doi: 10.1001/jamanetworkopen.2024.25614.

    PMID: 39158916DERIVED

MeSH Terms

Interventions

BID protein, humanPregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

Fangqiong Li

CONTACT

+8602867258840lifangq@haisco.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

December 1, 2020

Study Start

December 2, 2020

Primary Completion

November 9, 2022

Study Completion

November 16, 2022

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)