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

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192113
• Other study ID #: JGAZSY091109
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2010
• Last updated: November 5, 2012
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2012
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: SFDA
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1072
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• Mecobalamin IV Injection
Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks
• Mecobalamin IM injection
Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No