Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109) - Full Text View

Purpose

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

Condition	Intervention	Phase
Peripheral Neuropathy	Drug: Mecobalamin IV Injection Drug: Mecobalamin IM injection Drug: Mecobalamin IV or IM injection	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label, Randomized, Multi-center Clinical Trial to Evaluate the Safety and Efficacy in Peripheral Neuropathies Patients Treated With Mecobalamin Injection

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Peripheral Nerve Disorders

Drug Information available for: Mecobalamin

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline [ Time Frame: Baseline & End of Week 4 ] [ Designated as safety issue: No ]
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.
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline [ Time Frame: Baseline and End of Week 4 ] [ Designated as safety issue: No ]
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%.

Secondary Outcome Measures:

Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline [ Time Frame: Baseline and End of Week 2 ] [ Designated as safety issue: No ]
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.
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline [ Time Frame: Baseline and End of Week 2 ] [ Designated as safety issue: No ]
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%.
Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline [ Time Frame: Baseline and End of Week 4 ] [ Designated as safety issue: No ]
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 the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline [ Time Frame: Baseline and End of Week 4 ] [ Designated as safety issue: No ]
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%.

Enrollment:	1072
Study Start Date:	April 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

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

Exclusion criteria:

Pregnancy, preparation for pregnancy or breast-feeding women
Peripheral neuropathy caused by drugs, poisoning, cancer or genetic
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.
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)
Diagnosis of patients with diabetic peripheral neuropathy, but has diabetes ketosis, ketoacidosis and severe infection within the past two weeks
Bleeding or bleeding tendency in 2 months
Have allergy
Noncompliance or cannot meet those
Participation in other clinical trials in the last 3 months
Participant unsuitable to participate in this test as investigator considering

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192113

Locations

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

Sponsors and Collaborators

Eisai Co., Ltd.

Investigators

Principal Investigator:

Jvming Lu

The General Hospital of the People's Liberation Army

More Information

No publications provided

Responsible Party:	Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:	NCT01192113 History of Changes
Other Study ID Numbers:	JGAZSY091109
Study First Received:	August 26, 2010
Last Updated:	November 5, 2012
Health Authority:	China: SFDA

Keywords provided by Eisai Inc.:

Mecobalamin
peripheral neuropathy
diabetic neuropathy

Additional relevant MeSH terms:

Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms

Poisoning
Substance-Related Disorders
Vitamin B 12
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013