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Completed

NCT Number: NCT02035111

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

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The People's Hospital,Huaibei, Huaibei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tianshu capsule

Drug

Sugar pill

Drug

Primary outcomes

  1. Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline

    Time frame: -4w,0,4w,8w,12w,16w

Secondary outcomes

  1. Change in seizure duration of Migraine Per 4 weeks at Week 16 from baseline.

    Time frame: -4w,0,4w,8w,12w,16w

  2. Change in degree of pain of Migraine Per 4 weeks at Week 16 from baseline.

    Time frame: -4w,0,4w,8w,12w,16w

  3. Change in the days using acute therapy of Migraine Per 4 weeks at Week 16 from baseline.

    Time frame: -4w,0,4w,8w,12w,16w

  4. Proportion of subjects whose number or days of migraine attacks reduce at least 50%.

    Time frame: -4w,0,4w,8w,12w,16w

  5. Change in number of concomitant migrainous symptoms attacks Per 4 weeks at Week 16 from baseline.

    Time frame: -4w,0,4w,8w,12w,16w

  6. Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, and clinical laboratory tests.

    Time frame: 0, 12w

    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.

Sponsors and collaborators

Lead sponsor

Jiangsu Kanion Pharmaceutical Co., Ltd

Industry

Collaborators

  • Beijing Bionovo Medicine Development Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2014
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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