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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IPR-15007365 |
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Date of registration:
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2015-11-03 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Multi-center, Randomized, Double Blinding, Placebo-Controlled Clinical Trial of Dl-3-Butylphthalide in the Treatment of Amyotrophic Lateral Sclerosis
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Scientific title:
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A Multi-center, Randomized, Double Blinding, Placebo-Controlled Clinical Trial of Dl-3-Butylphthalide in the Treatment of Amyotrophic Lateral Sclerosis |
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Date of first enrolment:
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2015-11-04 |
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Target sample size:
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Treatment group:147;Control group:147; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=12354 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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Countries of recruitment
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China
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Contacts
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Name:
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Cui Liying
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Address:
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1 Shuaifuyuan, Wangfujing Street, Dongcheng District, Beijing
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Telephone:
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+86 010 65296373 |
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Email:
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pumchcly@yahoo.com.cn |
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Affiliation:
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Name:
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Liu Mingsheng
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Address:
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1 Shuaifuyuan, Wangfujing Street, Dongcheng District, Beijing
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Telephone:
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+86 010 65296373 |
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Email:
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pumclms@126.com |
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Affiliation:
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Peking Union Medical College Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) The patient or the patients legal representative have provided singed written informed consent;
(2) Diagnosis of "probable" or "definite" amyotrophic lateral sclerosis according to the revised El Escorial revised criteria;
(3) Ages 20 to 75 years inclusive;
(4) First ALS symptoms occurred <=3 monthss prior to screening;
(5) Not taking riluzole for at least 3 month prior to the screening visit.
Exclusion criteria: (1) Patients whose EMG examination reveals motor nerve conduction block or sensory nerve conduction abnormalities;
(2) Patients in whom causes of neuromuscular weakness other than ALS;
(3) Patients who are diagnosed as having dementia or mental disorders;
(4) Patients who have serious diseases including cardiovascular, liver, kidney or other serious disease;
(5) Onset of the weakness of respiratory muscle.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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amyotrophic lateral sclerosis
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Intervention(s)
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Treatment group:to give Butylphthalide soft capsules, 2 / time, 3 times / day, fasting;Control group:to give placebo, 2 / time, 3 times / day, fasting;
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Primary Outcome(s)
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ALSFRS-R;
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Secondary Outcome(s)
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survival rate;MUNE;Muscle strength;Pulmonary function testing;Clinical overall impression score;
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Source(s) of Monetary Support
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National “Twelve Five-Year” Scientific Support Plan Project, CSPC-NBP Pharmaceutical Co., Ltd.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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