Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
SYHA1402 for Diabetic Peripheral Neuropathy
NCT05116111Phase 2
Key facts
- Status
- Unknown
- Start
- Dec 2021
- Primary completion
- May 2023
- Modality
- Small Molecules
- Drugs
- syha1402
- Conditions
- diabetic peripheral neuropathy (DPN)
01
Overview
Phase 2, randomised, double-blind trial of syha1402 in diabetic peripheral neuropathy (DPN) (3 arms), sponsored by CSPC ZhongQi Pharmaceutical Technology. Primary endpoint: Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS) - Sensory Test Score at 16 weeks. Status: unknown.
02
Design
3 arms- Study design
- RandomizedDouble-blind
SYHA1402 1000 mg
SYHA1402 1000 mg + Placebo 500 mg twice daily
SYHA1402 1500 mg
SYHA1402 1500 mg twice daily
Placebo
Placebo 1500 mg twice daily
03
Who it enrols
Patients aged 18-75 with Type 1 or Type 2 diabetes and Distal Symmetric Polyneuropathy (DSPN), having stable glucose control and TCNS score >= 6.
04
Endpoints
Primary
Change from baseline in modified Toronto Clinical Neuropathy Score (mTCNS) - Sensory Test Score
Secondary
Change from baseline in overall score and symptom score of mTCNS
Change from baseline in Toronto Clinical Neuropathy Score (TCNS)
Change from baseline in Nerve Conduction Velocities (NCVs) and Amplitude
Change from baseline in Visual Analogue Scale (VAS)
Change from baseline in the 36-Item Short-Form Health Survey (SF-36) score
Clearance
Volume of Distribution
Incidence of adverse events (AEs)
Beyond the preview
Go deeper on NCT05116111.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT05116111.