A Phase II Study of NB001 for Acute Migraine Treatment
ConditionMigraine
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinese PLA General Hospital
About this trial
The goal of this observational study is to Evaluate the Efficacy and Safety of NB001 for the Acute Treatment of Migraine in Adult patients diagnosed with migraine.
Eligibility criteria
Qualifiers
The patient is aged ≥18 and ≤65 years at the Screening Visit, of either sex.
The patient has a diagnosis of migraine with aura or migraine without aura as defined by the ICHD-3 criteria confirmed at the Screening Visit.
The patient has had an onset of migraine at <50 years of age, with a history of migraine (with or without aura) of at least 1 year prior to the Screening Visit.
According to the investigator's judgment, the patient has had 2 to 8 moderate or severe migraine attacks per month in the 3 months prior to the Screening Visit.
Disqualifiers
The patient has a severe allergic constitution, or has known or suspected allergies to the investigational product or its excipients as judged by the investigator.
The patient is unable to distinguish migraine attacks from tension-type headaches or other headaches.
The patient has an average history of ≥15 headache days per month in the 3 months prior to the Screening Visit, or currently meets the ICHD-3 diagnostic criteria for chronic migraine, as judged by the investigator.
The patient has special types of migraine, such as hemiplegic migraine or migraine with brainstem aura.
Trial design
Treatments tested in this trial
- One tablet of NB001 plus three tablets of placebo
- Two tablets of NB001 plus two tablets of placebo
- Four tablets of NB001
- Four tablets of placebo
Treatment groups
120 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Chinese PLA General Hospital
Lead sponsor
Hebei Provincial People's Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Nanjing Brain Hospital
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Xiangya Hospital of Central South University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
940 Hospital of the People's Liberation Army Joint Logistic Support Force
Collaborator
People's Hospital of Wuhan University
Collaborator
The First Hospital of Jilin University
Collaborator
The First Affiliated Hospital of Dalian Medical University
Collaborator
Peking Union Medical College Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
The Second Affiliated Hospital of Army Medical University
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
The Second Affiliated Hospital of the Air Force Medical University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Jiangsu Province Nanjing Brain Hospital
Collaborator
Source ClinicalTrials.gov