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| Name | Class |
|---|---|
| Hebei Provincial People's Hospital | UNKNOWN |
| Guangdong Provincial People's Hospital | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One tablet of NB001 plus three tablets of placebo | Experimental |
| |
| Two tablets of NB001 plus two tablets of placebo | Experimental |
| |
| Four tablets of NB001 | Experimental |
| |
| Four tablets of placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One tablet of NB001 plus three tablets of placebo | Drug | Take 1 tablet of NB001 + 3 tablets of placebo at the onset of moderate-to-severe acute migraine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | 1.Proportion of subjects with no pain at 2 hours post-dose; 2.proportion of subjects with no most bothersome symptom (MBS) at 2 hours post-dose. | 2 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects with Pain Relief from Baseline at 2 Hours Post-Dose | Proportion of subjects with pain relief (defined as reduction from moderate/severe migraine-like headache at baseline [pre-dose] to mild headache or no headache) at 2 hours post-dose. | 2 hours post-dose |
| Restoration of Normal Function at 2 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion with pain free at each post-dose time points. | Proportion of subjects with pain free at all recorded time points after dosing; | At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose |
| Proportion with pain relief at each post-dose time points. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Dong, Doctor | Contact | +8618910685535 | dong_zhaozhao@126.com | |
| Mingjie Zhang, Doctor | Contact | +8618910276582 | mjzhangnk@163.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C557530 | 5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol |
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| Nanjing Brain Hospital |
| UNKNOWN |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| 940 Hospital of the People's Liberation Army Joint Logistic Support Force | OTHER |
| People's Hospital of Wuhan University | UNKNOWN |
| The First Hospital of Jilin University | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| The Second Affiliated Hospital of Army Medical University | UNKNOWN |
| Second Xiangya Hospital of Central South University | OTHER |
| The Second Affiliated Hospital of Air Force Military Medical University | OTHER |
| Fujian Medical University Union Hospital | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| Jiangsu Province Nanjing Brain Hospital | OTHER |
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| Two tablets of NB001 plus two tablets of placebo | Drug | Take 2 tablets of NB001 plus 2 tablets of placebo at the onset of moderate-to-severe acute migraine. |
|
| Four tablets of NB001 | Drug | Take 4 tablets of NB001 at the onset of moderate-to-severe acute migraine. |
|
| Four tablets of placebo | Drug | Take 4 tablets of placebo at the onset of moderate-to-severe acute migraine. |
|
Proportion of subjects with restoration of normal function (as reported by the Functional Disability Scale) at 2 hours post-dose. |
| 2 hours post-dose. |
| Proportion of subjects using rescue medication within 24 hours post-dose. | Proportion of subjects using rescue medication within 24 hours post-dose. | Within 24 hours post-dose. |
| Proportion of subjects with sustained pain relief between 2 and 24 Hours Post-Dose | Proportion of subjects with sustained pain relief (defined as pain relief at 2 hours post-dose, no use of rescue medication, and no moderate/severe headache between 2 and 24 hours) between 2 and 24 hours post-dose. | Between 2 and 24 hours post-dose. |
| Proportion of subjects with sustained pain relief between 2 and 48 hours post-dose. | Proportion of subjects with sustained pain relief between 2 and 48 hours post-dose. | Between 2 and 48 hours post-dose. |
| Proportion of subjects with sustained pain-free status between 2 and 24 Hours Post-Dose | Proportion of subjects with sustained pain-free status (defined as pain-free at 2 hours post-dose, no use of rescue medication, and no mild/moderate/severe headache between 2 and 24 hours) between 2 and 24 hours post-dose. | Between 2 and 24 Hours Post-Dose |
| Proportion of subjects with sustained pain-free status between 2 and 48 hours post-dose. | Proportion of subjects with sustained pain-free status between 2 and 48 hours post-dose. | Between 2 and 48 hours post-dose. |
| Proportion of subjects with pain relief at 15, 30, 45, 60, and 90 minutes post-dose. | Proportion of subjects with pain relief at 15, 30, 45, 60, and 90 minutes post-dose. | At 15, 30, 45, 60, and 90 minutes post-dose. |
| Proportion of subjects without MBS (Migraine-associated Symptoms)at 15, 30, 45, 60, and 90 minutes post-dose. | Proportion of subjects without MBS (Migraine-associated Symptoms)at 15, 30, 45, 60, and 90 minutes post-dose. | At 15, 30, 45, 60, and 90 minutes post-dose. |
| Proportion of subjects with pain-free status at 15, 30, 45, 60, and 90 minutes post-dose. | Proportion of subjects with pain-free status at 15, 30, 45, 60, and 90 minutes post-dose. | At 15, 30, 45, 60, and 90 minutes post-dose. |
Proportion with pain relief at each post-dose time points. |
| At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose |
| Proportion with absence of MBS at each post-dose time points. | Proportion of subjects with no MBS (migraine-associated symptoms) at each post-dose time points. | At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose |
| Proportion of subjects with restoration of normal function at all post-dose time points. | Proportion of subjects with restoration of normal function at all post-dose time points. | At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose |
| Resolution of Baseline Phonophobia at Each Post-Dose Time Point | Among subjects who reported phonophobia as an MBS (migraine-associated symptoms)at baseline, the percentage of subjects with resolution of this symptom at each post-dose time point. | At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose |
| Proportion of subjects with resolution of baseline photophobia at each post-dose time point | Among subjects who reported photophobia as an MBS (migraine-associated symptoms)a at baseline, the percentage of subjects with resolution of this symptom at each post-dose time point. | At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose |
| Proportion of subjects with resolution of baseline nausea at each post-dose time point. | Among subjects who reported nausea as an MBS before administration, the proportion of subjects with resolution of this symptom at each time point after administration. | At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose |
| Proportion of subjects with sustained absence of MBS from 2 to 24 hours post-dose. | Proportion of subjects with sustained absence of MBS from 2 to 24 hours post-dose. | From 2 to 24 hours post-dose. |
| Proportion of subjects with sustained absence of MBS from 2 to 48 hours post-dose. | Proportion of subjects with sustained absence of MBS from 2 to 48 hours post-dose. | From 2 to 48 hours post-dose. |
| Proportion of subjects with sustained normal functional ability from 2 to 24 hours post-dose. | Proportion of subjects with sustained normal functional ability from 2 to 24 hours post-dose. | From 2 to 24 hours post-dose. |
| Proportion of subjects with sustained normal functional ability from 2 to 48 hours post-dose. | Proportion of subjects with sustained normal functional ability from 2 to 48 hours post-dose. | From 2 to 48 hours post-dose. |
| Proportion of subjects with overall improvement at all recorded post-dose time points and Patient Global Impression of Change (PGI-C) scores. | Proportion of subjects with overall improvement at all recorded post-dose time points and Patient Global Impression of Change (PGI-C) scores. | At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose |
| D009422 | Nervous System Diseases |