A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.

Migraine Clinical Trial

Official title:

To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035111
• Other study ID #: Z-TSJN-JN-?
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2014
• Last updated: April 13, 2016
• Start date: March 2014
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Jiangsu Kanion Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache.

Description:

Primary headache disorders,particularly migraine is globally prevalent. Many studies show the burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of participation in work and social activities, and heavy financial costs.

The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache. To provide a safe and effective treatment of Migraine Headache.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 947
• Est. completion date: November 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Must meet the Migraine diagnosis.

• Age of onset should be before age 50 years.

• Migraine must have been occurring for 1 year preceding entry into the trial.

• The number of migraine attack should be no less than 6 for a period of 3 months prior to Screening stage.

• The number of migraine days is to be 2-8 for a period of 1 month prior to screening for entry into the trial.

• Migraine days should be less than 15 for a period of 1 month prior to screening for entry into the trial.

• Ages 18-65.

• Participant can understand and complete the Headache diary.

• All participants signed the informed consent.

Exclusion Criteria:

• Other migraine prophylactic medication is continued 3 months prior to the drug trial.

• Participants who have taken Tianshu capsule during 1 month prior to Screening stage.

• The number of acute treatment for migraine is more than 10 per month.

• Participants who have taken antipsychotics or antidepressant medications (unless only for migraine prophylaxis) during the previous 3 months.

• Participants who abuse alcohol or other drugs.

• Participants who are resistant to all acute migraine drugs prescribed optimally.

• hypotension or uncontrolled hypertension.

• Severe infections.

• Malignancy.

• Significant medical history of such as cardiac disease, cerebrovascular disease, liver disease, nephropathy etc.

• Known allergies or serious side effects with Tianshu capsule in the past.

• Breastfeeding, pregnant and potentially fertile women participant.

• History of cluster headaches, tension-type headache, vascular headache with non-migraine, drug - dependence headache.

• Secondary headaches, including hypertension, post-traumatic brain syndrome etc.

• Participants who have taken migraine prophylactic medication regularly during 1 month prior to Screening stage.

• Participants who are taking part in other clinical trials.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Tianshu capsule

• Sugar pill

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Daxing hospital of Traditional Chinese Medicine	Beijing	Beijing
China	The People's Hospital,Cangzhou	Cangzhou	Hebei
China	The Affiliated Hospital of Changchun University of Chinese medicine	Changchun	Jilin
China	The People's Hospital,Huaibei	Huaibei	Anhui
China	Jinan hospital of traditional Chinese Medicine	Jinan	Shandong
China	The second affiliated hospital of Shandong Traditional Chinese Medicine University	Jinan	Shandong
China	Affiliated Hospital of Jining Medical University	Jining	Shandong
China	Jining First Hospital	Jining	Shandong
China	Kaifeng hospital of Traditional Chinese Medicine	Kaifeng	Henan
China	Langfang hospital of Traditional Chinese Medicine	Langfang	Hebei
China	Luohe hospital of Traditional Chinese Medicine	Luohe	Henan
China	Quanzhou First Hospita	Quanzhou	Fujian
China	SanMing First Hospital	Sanming	Fujian
China	The two six zero hospital of Chinese people's Liberation Army	Shijiazhuang	Hebei
China	Jilin brain hospital	Siping	Jilin
China	Tangshan TCM Hospital	Tangshan	Hebei
China	Wuhan sixth hospital	Wuhan	Hubei
China	Xi An Hospital of Traditional Chinese Medicine	Xian	Shanxi
China	Yiyang central hospital	Yiyang	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Kanion Pharmaceutical Co., Ltd	Beijing Bionovo Medicine Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline		-4w,0,4w,8w,12w,16w	No
Secondary	Change in seizure duration of Migraine Per 4 weeks at Week 16 from baseline.		-4w,0,4w,8w,12w,16w	No
Secondary	Change in degree of pain of Migraine Per 4 weeks at Week 16 from baseline.		-4w,0,4w,8w,12w,16w	No
Secondary	Change in the days using acute therapy of Migraine Per 4 weeks at Week 16 from baseline.		-4w,0,4w,8w,12w,16w	No
Secondary	Proportion of subjects whose number or days of migraine attacks reduce at least 50%.		-4w,0,4w,8w,12w,16w	No
Secondary	Change in number of concomitant migrainous symptoms attacks Per 4 weeks at Week 16 from baseline.		-4w,0,4w,8w,12w,16w	No
Secondary	Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, and clinical laboratory tests.	Adverse event reports will be assessed at 0, 4w, 8w, 12w, 16w. clinical laboratory tests including WBC, RBC, HGB, PLT, LEU, ERY, PRO,Stool routine, ALT, AST, TBil, ALP, GGT, BUN, Cr will be assessed at 0, 12w.; Electrocardiogram will be assessed at 0, 12w. Vital sign measurements will be assessed at -4w, 0, 4w, 8w, 12w, 16w.	0, 12w	Yes