Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)

An Open-label, Randomized, Multi-center Clinical Trial to Evaluate the Safety and Efficacy in Peripheral Neuropathies Patients Treated With Mecobalamin Injection

This is an open-label, randomized, multi-center clinical trial to evaluate the safety and efficacy in peripheral neuropathies patients treated with Mecobalamin Injection

Study Overview

• Status: Completed
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Drug: Mecobalamin IV Injection; Drug: Mecobalamin IM injection; Drug: Mecobalamin IV or IM injection

• Study Type: Interventional
• Enrollment (Actual): 1072
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • The institute of rehabilitation medicine
  • Shanghai, China
    • Rui Jin Hospital
  • Shenzhen, China
    • Shenzhen Hospital of Beijing University
  • Anhui
    • Hefei, Anhui, China
      • The 1st Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China
      • The General Hospital of the People's Liberation Army
    • Beijing, Beijing, China
      • The institute of rehabilitation medicine
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital of Nanfang Medical Unversity
    • Guangzhou, Guangdong, China
      • The 1st People Hospital of Guangzhou
  • Guangxi
    • Nanning, Guangxi, China
      • the 1st Hospital affliated to Guangxi Medical University
  • Hebei
    • Shijiazhuang, Hebei, China
      • The 3rd Hospital of Hebei Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital
    • Wuhan, Hubei, China
      • the people Hospital
    • Wuhan, Hubei, China
      • Xiehe Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • the 1st Hospital of Nanjing
    • Nanjing, Jiangsu, China
      • Zhong Xi Yi Jie He Hospital of Jiangsu
    • Suzhou, Jiangsu, China
      • the 2nd Hospital of Suzhou University
    • Yangzhou, Jiangsu, China
      • Subei People Hospital
    • Yangzhou, Jiangsu, China
      • The 1st People Hospital of Yangzhou
    • Zhenjiang, Jiangsu, China
      • The Affiliated Hospital of Jiangsu University
  • Shanghai
    • Shanghai, Shanghai, China
      • Changhai Hospital
    • Shanghai, Shanghai, China
      • Ruijing Hospital
    • Shanghai, Shanghai, China
      • the 10th People Hospital of Shanghai
    • Shanghai, Shanghai, China
      • the 10th People Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • The 1st Center Hospital of Tianjin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Clinical diagnosis of diabetes induced peripheral neuropathy, other peripheral neuropathies (Idiopathic, nutritional and metabolic nature of entrapment neuropathy).
2. Significant spontaneous pain and / or numbness and other symptoms of neuropathy. TSS (Total Symptom Score) >=7.5.
3. Participation in clinical trials voluntarily and signed informed consent form

Exclusion criteria:

1. Pregnancy, preparation for pregnancy or breast-feeding women
2. Peripheral neuropathy caused by drugs, poisoning, cancer or genetic
3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST): 2.0 times more than the upper limit of normal; Creatinine (Cr) 1.5 times above the upper limit of normal.
4. Serious organ disease or other serious primary disease merger, the mentally ill, poorly controlled hypertension (blood pressure more than 150/100 mmHg after using antihypertensive drugs)
5. Diagnosis of patients with diabetic peripheral neuropathy, but has diabetes ketosis, ketoacidosis and severe infection within the past two weeks
6. Bleeding or bleeding tendency in 2 months
7. Have allergy
8. Noncompliance or cannot meet those
9. Participation in other clinical trials in the last 3 months
10. Participant unsuitable to participate in this test as investigator considering

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Diabetic Peripheral Neuropathy (IV)	Drug: Mecobalamin IV Injection; Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks
Experimental: Group B: Diabetic Peripheral Neuropathy (IM)	Drug: Mecobalamin IM injection; Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks
Experimental: Group C: Idiopathic Peripheral Neuropathy	Drug: Mecobalamin IV or IM injection; Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
Experimental: Group D: Nutritional & Metabolic Peripheral Neuropathy	Drug: Mecobalamin IV or IM injection; Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
Experimental: Group E: Compression Peripheral Neuropathy	Drug: Mecobalamin IV or IM injection; Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline	The TSS of peripheral neuropathy is used to score the intensity & frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.	Baseline & End of Week 4
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline	TSS of peripheral neuropathy is used to score the intensity & frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 4 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.	Baseline and End of Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline	The TSS of peripheral neuropathy is used to score the intensity & frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 2 weeks of treatment.	Baseline and End of Week 2
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline	TSS of peripheral neuropathy is used to score the intensity/ frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 2 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.	Baseline and End of Week 2
Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline	The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip & knee flexion/ extension & remote foot dorsiflexion/ plantar flexion [scored as normal, 25% weak, 50% weak, 75% weak, and paralysis]), reflex (response at the quadriceps & ankle [normal score=0, decreased score=1, absent score=2], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position [normal score=0, decreased score=1, absent score=2]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.	Baseline and End of Week 4
Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline	The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip & knee flexion/ extension & remote foot dorsiflexion/ plantar flexion [scored as normal, 25% weak, 50% weak, 75% weak, and paralysis]), reflex (response at the quadriceps & ankle [normal score=0, decreased score=1, absent score=2], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position [normal score=0, decreased score=1, absent score=2]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment. Rate of NIS-LL change = (NIS-LL difference value/NIS-LL before treatment)×100%.	Baseline and End of Week 4

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Principal Investigator: Jvming Lu, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 30, 2010
• First Posted (Estimate): August 31, 2010

Study Record Updates

• Last Update Posted (Estimate): November 7, 2012
• Last Update Submitted That Met QC Criteria: November 5, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: peripheral neuropathy; diabetic neuropathy; Mecobalamin
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Vitamin B 12
• Other Study ID Numbers: JGAZSY091109