The purpose of this study is to assess the efficacy of Acetyllevocarnitine Hydrochloride Tablets compared with placebo after 24 weeks, in chinese patients with paresthesia caused by Diabetic Peripheral Neuropathy (DPN).
This 24-week, multicentre, randomised, double-blind, placebo-controlled phase III study is to assess the efficacy and safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese patients with paresthesia caused by DPN.The trial included a 2-week screening period, a 1-week placebo run-in period, a 24-week randomized treatment period, and a 2-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
516
500 mg (2×250 mg/tablet) after meal, 3 times per day
500 mg (2×250 mg/tablet) after meal, 3 times per day
mTCNS total score change from baseline at week 24
Changes in Modified Toronto Clinical Neuropathy Score (mTCNS) total score from baseline at Week 24. Maximum mTCNS is 33, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.
Time frame: Baseline and week 24
mTCNS total score change from baseline at week 12
Changes in Modified Toronto Clinical Neuropathy Score (mTCNS) total score from baseline at Week 12. Maximum mTCNS is 33, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.
Time frame: Baseline and week 12
Changes in each item score of mTCNS from baseline at week 12 and week 24
The mTCNS contains the 11 items that assess symptoms and signs, and each item maximum is 3 points, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.
Time frame: Baseline, Weeks 12 and 24
TCNS total score change from baseline at week 12 and week 24
Changes in Toronto Clinical Neuropathy Score (TCNS) total score from baseline at Week 12 and Week 24. Maximum TCNS is 19, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.
Time frame: Baseline, Weeks 12 and 24
Numeric Rating Scale (NRS) score change from baseline at week 24
Changes in Numeric Rating Scale (NRS) score from baseline at Week 24. Maximum NRS is 10, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.
Time frame: Baseline and week 24
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Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Hainan Third People's Hospital
Sanya, Hainan, China
Handan Central Hospital
Handan, Hebei, China
Hebei Petro China Center Hospital
Langfang, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
Kaifeng Traditional Chinese Medicine Hospital
Kaifeng, Henan, China
Luoyang Third People's Hospital
Luoyang, Henan, China
...and 24 more locations
Changes in Nerve Conduction Velocity (NCV) from baseline at week 24
Time frame: Baseline and week 24
Changes in Nerve Conduction Amplitude from baseline at week 24
Time frame: Baseline and week 24