Diabetic Peripheral Neuropathy (DPN)Phase 3NCT05319275
Study of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by DPN
A Phase 3 study testing Acetyllevocarnitine Hydrochloride Tablets in people with Diabetic Peripheral Neuropathy (DPN) and Paresthesia, run by Haisco Pharmaceutical Group Co., Ltd. at 34 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN), Paresthesia
- What is being tested?
- Acetyllevocarnitine Hydrochloride Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 516 participants
- Where
- 34 sitesChina
- Study dates
- 23 Jul 2020to 25 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 70 years, Male and female patients;
- Type 1 or 2 diabetes mellitus on hypoglycemic therapy for 3 months or more, and clinical diagnosis of DPN;
- HbA1c < 9.0%;
- Toronto Clinical Neuropathy Score ≥ 6 at screening and baseline.
Who cannot join
- Peripheral neuropathy caused by other diseases;
- History of acute complications of diabetes within the past 6 months, such as diabetic ketoacidosis, diabetic hyperosmolar hyperglycemia syndrome or lactic acidosis, etc.;
- Severe peripheral arterial disease; severe cardiopulmonary disease; or have a history of myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months before enrollment; or uncontrolled asthma or shortness of breath 2 months before enrollment; World Health Organization (WHO) cardiac function class III-IV; systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at screening;
- Any infection at the screening visit that is not suitable for study participation;
- Aspartate Transaminase (AST) or Alanine Transaminase (ALT) or total bilirubin or creatinine > 2 times Upper Limit of Normal (ULN);
- Known allergy to L-carnitine ingredients;
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- Severe systemic or psychiatric illness, history of epilepsy;
- History of malignancy or antitumor therapy;
- Severe bleeding disorder;
- Clinically significant abnormalities in thyroid function tests;
- Triglyceride >5.6 mmol/L;
- Change of 2 points or more in the same item in mTCNS;
- Nursing or pregnant women.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites
Beijing Hospital
Beijing
Beijing Luhe Hospital, Capital Medical University
Beijing
Beijing Pinggu Hospital
Beijing
Binzhou Medical University Hospital
Binzhou, Shandong
Chongqing People's Hospital
Chongqing
Yongchuan Hospital of Chongqing Medical University
Chongqing
Guangzhou First People's Hospital
Guangzhou, Guangdong
Handan Central Hospital
Handan, Hebei
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Huizhou Central People's Hospital
Huizhou, Guangdong
Jiujiang Traditional Chinese Medicine Hospital
Jiujiang, Jiangxi
Huaihe Hospital of Henan University
Kaifeng, Henan
Kaifeng Traditional Chinese Medicine Hospital
Kaifeng, Henan
Hebei Petro China Center Hospital
Langfang, Hebei
Luoyang Third People's Hospital
Luoyang, Henan
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
The Fourth Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Qingdao Central Hospital
Qingdao, Shandong
Hainan Third People's Hospital
Sanya, Hainan
Taihe Hospital
Shiyan, Hubei
Tianjin First Central Hospital
Tianjin
Weihai Central Hospital
Weihai, Shandong
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Xinxiang First People's Hospital
Xinxiang, Henan
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Affiliated Hospital of Yanbian University
Yanbian, Jilin
Yichun People's Hospital
Yichun, Jiangxi
The First People's Hospital of Yinchuan
Yinchuan, Ningxia
Henan Provincial People's Hospital
Zhengzhou, Henan
The Medical Group of Zhengzhou First People's Hospital
Zhengzhou, Henan
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
About this study
Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by Diabetic Peripheral Neuropathy
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).
Read the detailed description
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.
- Conditions
- Diabetic Peripheral Neuropathy (DPN), Paresthesia
- Being tested
- Acetyllevocarnitine Hydrochloride Tablets, Placebo
- Medical subject headings
- Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyllevocarnitine Hydrochloride TabletsDrug
500 mg (2×250 mg/tablet) after meal, 3 times per day
PlaceboDrug
500 mg (2×250 mg/tablet) after meal, 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| Acetyllevocarnitine Hydrochloride Tablets | Experimental | Not described Receives: Drug: Acetyllevocarnitine Hydrochloride Tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 24
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 24
Changes in Nerve Conduction Velocity (NCV) from baseline at week 24
Measured: Baseline and week 24
Changes in Nerve Conduction Amplitude from baseline at week 24
Measured: Baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start23 Jul 2020
- Primary completion7 Dec 2021
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lixin Guo, Study chair, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319275
- Sponsor's protocol ID
- Heisco19-301
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05319275
- Acronym / sponsor ID
- Heisco19-301
- Conditions
- Diabetic Peripheral Neuropathy (DPN), Paresthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetyllevocarnitine Hydrochloride Tablets | Experimental | Drug: Acetyllevocarnitine Hydrochloride Tablets |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 70 years, Male and female patients;
- Type 1 or 2 diabetes mellitus on hypoglycemic therapy for 3 months or more, and clinical diagnosis of DPN;
- HbA1c < 9.0%;
- Toronto Clinical Neuropathy Score ≥ 6 at screening and baseline.
Key exclusion criteria (13 listed)
- Peripheral neuropathy caused by other diseases;
- History of acute complications of diabetes within the past 6 months, such as diabetic ketoacidosis, diabetic hyperosmolar hyperglycemia syndrome or lactic acidosis, etc.;
- Severe peripheral arterial disease; severe cardiopulmonary disease; or have a history of myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months before enrollment; or uncontrolled asthma or shortness of breath 2 months before enrollment; World Health Organization (WHO) cardiac function class III-IV; systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at screening;
- Any infection at the screening visit that is not suitable for study participation;
- Aspartate Transaminase (AST) or Alanine Transaminase (ALT) or total bilirubin or creatinine > 2 times Upper Limit of Normal (ULN);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyllevocarnitine Hydrochloride Tablets500 mg (2×250 mg/tablet) after meal, 3 times per day | Drug | Acetyllevocarnitine Hydrochloride Tablets |
| Placebo500 mg (2×250 mg/tablet) after meal, 3 times per day | Drug | Placebo |
Primary outcome
mTCNS total score change from baseline at week 24
Time frame: Baseline and 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.
6 secondary outcomes
mTCNS total score change from baseline at week 12
Time frame: Baseline and week 12
Changes in each item score of mTCNS from baseline at week 12 and week 24
Time frame: Baseline, Weeks 12 and 24
TCNS total score change from baseline at week 12 and week 24
Time frame: Baseline, Weeks 12 and 24
Numeric Rating Scale (NRS) score change from baseline at week 24
Time frame: Baseline and week 24
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lixin Guo study chair
Beijing Hospital
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetyllevocarnitine Hydrochloride Tablets in people with Diabetic Peripheral Neuropathy (DPN) and Paresthesia, run by Haisco Pharmaceutical Group Co., Ltd. at 34 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mTCNS total score change from baseline at week 24 (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.