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AzTrials

Migraine Without AuraPhase 3ATEMNCT05416476

Anisodine Hydrobromide For The Preventive Treatment Of Episodic Migraine

A Phase 3 study testing Anisodine Hydrobromide in people with Migraine Without Aura and Migraine With Aura, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 19 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study,288 adult migraine patients aged 18-65 years (diagnosed with migraine without aura and/or migraine with aura, with at least a 1-year history)will be collected to evaluate the efficacy, safety and tolerability of Anisodine Hydrobromide in preventing migraine attacks in episodic migraine in adults. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Without Aura, Migraine With Aura
What is being tested?
Anisodine Hydrobromide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
288 participants
Where
19 sitesChina
Study dates
30 Oct 2023to 31 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to participate in this study.
  • The age at entry for trails involving adult subjects is 18-65 years (including both ends)；
  • According to ICHD-3(Headache Classification Committee of the International Headache Society,2018), individuals should be diagnosed with migraine without aura and/or migraine with aura, and should have a history of at least 1 year;
  • The age at first migraine onset should be <50 years;
  • Migraine attacks ≥ 4 days/month and < 15 days/month within 3 months prior to screening period (Refer to the definition of migraine days);
  • Within 3 months before entering the screening period, the number of headache (including migraine and other types of headache) attack days per month is less than 15 days/month (Refer to the definition of headache days);
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  • Be willing to take effective contraceptive measures during the period of participating in this experiment and within 28 days after the last time taking investigational product;
  • Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent in writing, agreeing to enter the baseline period.
  • The following criteria must be met during the baseline period to be eligible for entering the randomized, double-blind, placebo-controlled trial of the drug:
  • Migraine days ≥4 and <14 days within 4 weeks of baseline period(Evaluation based on the Annex 14.-Electronic Headache Diary);
  • Headache days < 14 days within 4 weeks of baseline period;
  • Completion of at least 80% of the electronic diary within 4 weeks of the baseline period(Within 28 days of the baseline period, the electronic diary has been completed for at least 23 days), and the investigator believes that the subject is able to read, understand, and complete the study questionnaire and headache diary;
  • Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent in writing, agreeing to enter the randomized, double-blind, placebo-controlled trials of the drug.

Who cannot join

  • Subjects with any of the following cannot participate in this study:
  • Subject diagnosed with possible migraine according to ICHD-3(2018);
  • Current and previous diagnosis of primary headache, secondary headache, or painful cranial neuropathy other than migraine(diagnostic criteria are defined according to ICHD-3,2018);
  • Past use of more than two of the following 7 drugs is ineffective after adequate use, the types of these drugs are as follows:
  • Type 1: Divalproex, Sodium Valproate
  • Type 2: Topiramate
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  • Type 3: Beta blockers(such as: Atenolol, Bisoprolol, Metoprolol, Nadolol, Nebivolol, Pindolol, Propranolol, Timolol)
  • Type 4: Tricyclic antidepressants(TCA) (such as: Amitriptyline, Nortriptyline, Protriptyline)
  • Type 5: Serotonin-norepinephrine reuptake inhibitors (SNRIs) (such as: Venlafaxine, Desvenlafaxine, Duloxetine, Milnacipran)
  • Type 6: Flunarizine, Verapamil
  • Type 7: lisinopril, Candesartan
  • Definition of treatment failure: No reduction in headache frequency, duration, or severity after 6 weeks of administration of the above drugs.
  • The following conditions are not defined as treatment failure:
  • Lack of sustained response to medication;
  • Can not be tolerated dose of drug
  • Use of drugs known to have significant interactions with the study drug (anisodine hydrobromide) (eg donepezil, donepezil hydrochloride, rivastigmine, etc.) in the 2 months prior to the baseline period and throughout the study period；
  • Use of prohibited drugs, Chinese patent drug, Chinese herbal medicines, instruments or therapies, etc. 2 months before the baseline period or during the baseline period (more details are in Prohibited Drugs/Treatments);
  • Subjects who intend to undergo head, face or neck injections of therapeutic or cosmetic Botulinum Toxin(such as Dysport, Botox, Xeomin, Myobloc and JeuvwauTM) during the study period or within 4 months before screening;
  • Simultaneous use of two or more drugs that may have migraine preventive effects within 2 months before the start of the baseline period or during the baseline period (more details are in Annex- The List of Migraine Preventive Medications ) (If only one prophylactic drug is used, the dose must be stable for the two months prior to the baseline period and throughout the study);
  • The following occurred within two months prior to the start of the baseline period:
  • Taking Ergotamines or Triptans for ≥10 days per month, or
  • Taking NSAIDs alone for ≥15 days compound or preparation of NSAIDs≥10 days, or
  • Taking Opioid or Barbiturate analgesics for ≥4 days per month
  • Subjects are expected to use the following prohibited drugs, Chinese patent drug, Chinese herbal medicines, instruments or protocols during double-blind treatment (more details are in Prohibited Drugs/Treatments);
  • Subject has active chronic pain syndrome (eg, fibromyalgia, chronic pelvic pain, facial pain, etc.);
  • Subject has a history of mental illness (eg, schizophrenia or bipolar disorder) or PHQ-9 score≥15；Subjects are allowed to enter the double-blind treatment period if they had a history of anxiety or depression and were taking no more than one psychotropic drug (excluding contraindicated drugs) (Subjects must have taken a stable therapeutic dose within 3 months prior to the baseline period);
  • Have a serious neurological disorder other than migraines (Note: Do not rule out single children febrile convulsion);
  • Patients with a history of malignant tumour within five years prior to the screening period, excluding non-melanoma skin cancer, cervical or breast ductal carcinoma in situ;
  • The screening period meets any of the following laboratory values:
  • Alanine transaminase (ALT) or aspartate aminotransferase (AST) >1.5×（upper limit of normal, ULN）, or
  • Total bilirubin(TBIL) >1.5×ULN （Subjects with diagnosed Gilbert syndrome excluded）
  • Heart disease such as coronary heart disease, severe heart failure and arrhythmia; history of glaucoma, bleeding disorders, stroke, transient ischemic attack (TIA), reconstructive surgery;
  • The subject has factors that the investigator believes may put the subject at significant risk or may confound the results of the study; The subject has any medical or other reasons for being unfit to participate in the study;
  • According to clinical interviews or C-SSRS questionnaires, the researcher believes that the subject is at risk of self-harm or harm to others;
  • Within 12 months before the screening period, according to the subject's medical records or the subject's self-reported history of drug or alcohol abuse;
  • Subjects expected to be pregnant or breastfeeding during the study period, or had a positive urine pregnancy test result at screening;
  • During the study period, female subjects of childbearing potential were reluctant to use an acceptable method of effective contraception; Infertile women are defined as follows:
  • -Have a history of menopause, defined as: Age: ≥55 years old, Menopause ≥12 months, or Age:<55 years old, no spontaneous menstruation for at least 2 years，or Age:<55 years old, have spontaneous menstruation in the past 1 year, but current is amenorrhea (spontaneous or secondary to hysterectomy), and abnormal postmenopausal Gonadotropin levels: luteinizing hormone(LH), follicle-stimulating hormone(FSH)>40IU/L or postmenopausal estradiol level <5ng/dL, or
  • Have a history of bilateral oophorectomy, or
  • Have a history of hysterectomy, or
  • Have a history of bilateral salpingectomy
  • Subjects who participated in other clinical trials within 3 months before the screening period;
  • Subjects who are allergic to anisodine hydrobromide or anisodine hydrobromide excipients;
  • Subjects who cannot maintain their original diet and living habits during the trial;
  • Subjects who intend to take estrogen and/or progesterone drugs during the screening period or after enrollment;
  • Subject is a researcher involved in the study or an immediate family member (parent, spouse, sibling or child).

Trial locations and contacts

19 sites in 1 country.

Kaiming Liu, MD & PHD contact

+8615068862055

2314411@zju.edu.cn

19 sites in 1 country

China19 sites, 19 recruiting

  • Dongyang People's Hospital

    Dongyang, Zhejiang, 322100

    Juanyan Chen, 13566929717

    Not yet recruiting

  • Guangdong 999 Brain Hospital

    Guangzhou, Guangdong, 510510

    Shuisheng Zhong, 13710665623

    Not yet recruiting

  • Xinhua Hospital of Zhejiang Province

    Hangzhou, Zhejiang, 310005

    You Wu, 15658882278

    Not yet recruiting

  • Tongde Hospital of Zhejiang Province

    Hangzhou, Zhejiang, 310012

    Xiaodong Zou, 15267162168

    Not yet recruiting

  • Kaiming Liu

    Hangzhou, Zhejiang, 370001

    Kaiming Liu

    Recruiting

  • The First People's Hospital of Huzhou City

    Huzhou, Zhejiang, 313000

    Mengxiong Pan, 15905723372

    Qun Gu

    Not yet recruiting

  • Jinhua People's Hospital

    Jinhua, Zhejiang, 321000

    Huijun Shao, 13868988986

    Not yet recruiting

  • Jinjiang Municipal Hospital

    Jinjiang, Fujian, 362200

    Zhiqiang Lin, 15359508512

    Benyan Luo

    Not yet recruiting

  • Medical Community of Linhai First People's Hospital

    Linhai, Zhejiang, 31700

    Guilian Ni, 13616689395

    Not yet recruiting

  • The First People's Hospital of Jiande

    Meicheng, Zhejiang, 311600

    Xiyao Zhao

    Not yet recruiting

  • The Second Affiliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

    Lichao Ye, 13015823208

    Not yet recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

    Gang Li, 13510706396

    Not yet recruiting

  • Shenzhen University General Hospital

    Shenzhen, Guangdong, 518055

    Hongya Zhang, 18126459965

    Not yet recruiting

  • Tiantai People's Hospital of Zhejiang Province

    Tiantai, Zhejiang, 317200

    Faming Wang, 13958502756

    Wenwu Hong

    Not yet recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Qiuling Tong, 13676780835

    Not yet recruiting

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    Yiwu, Zhejiang, 322000

    Guohua Zhao, 13777812308

    Not yet recruiting

  • The Second People's Hospital of Yuhuan

    Yuhuan, Zhejiang, 317600

    Xianhong Wu, 15157623310

    Not yet recruiting

  • The First People's Hospital of Zhaoqing

    Zhaoqing, Guangdong, 526020

    Youjia Li, 18902368836

    Not yet recruiting

  • People's Hospital Affiliated to Jiangsu University/Zhenjiang First People's Hospital

    Zhenjiang, Jiangsu, 212000

    Kun Zhao, 15905288637

    Not yet recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy, Safety, And Tolerability Of Anisodine Hydrobromide For The Preventive Treatment Of Episodic Migraine

In this study,288 adult migraine patients aged 18-65 years (diagnosed with migraine without aura and/or migraine with aura, with at least a 1-year history)will be collected to evaluate the efficacy, safety and tolerability of Anisodine Hydrobromide in preventing migraine attacks in episodic migraine in adults.

Read the detailed description
  1. Research contents: In this study,288 adult migraine patients aged 18-65 years (diagnosed with migraine without aura and/or migraine with aura, with at least a 1-year history)will be collected to evaluate the efficacy, safety and tolerability of Anisodine Hydrobromide in preventing migraine attacks in episodic migraine in adults.
  2. Research target: To evaluate the efficacy, safety and tolerability of oral Anisodine Hydrobromide in preventing migraine attacks in episodic migraine in adults, we used the change from baseline in migraine days per 4 weeks during the 12-week treatment period as the primary endpoint.
  3. Research design: This study uses a multicenter, randomized, double-blind, placebo-controlled, parallel design and plans to enroll 288 adult patients with episodic migraine. A total of 288 patients were planned to be enrolled, and all subjects were randomly assigned to group A (Anisodine Hydrobromide 1 mg bid) and group B (placebo 1 mg bid) according to a 1:1 ratio, with 144 subjects in each group.Both anisodine hydrobromide and placebo were produced and supplied by Chengdu First Pharmaceutical Limited Company. The enrolled subjects were orally administered Anisodine Hydrobromide 1 mg bid or placebo 1 mg bid for 12 consecutive weeks of treatment, and followed up for 4 weeks. That means doing face-to-face visits at the 4th, 8th, 12th and 16th weeks after dosing ,while affected by the epidemic or other special circumstances, video or telephone follow-up can be used. This study is divided into 3 phases: screening/baseline period (4 weeks, D-28~D-1), double-blind treatment period (12 weeks, D1~D84), follow-up period (4 weeks, D85-D112), a total of About 20 weeks.
  4. In order to ensure the quality of the trial, the sponsor and the researcher shall discuss and formulate the clinical research plan before the trial officially begins. Good Clinical Practice(GCP) training was given to the relevant researchers who participated in the experiment. The research center must manage experimental drugs in accordance with (SOP), including receipt, storage, distribution and recycling. In accordance with the GCP guidelines, necessary steps should be taken during the design and implementation phase of the study to ensure that the data collected are accurate, consistent, complete and credible. All observed results and abnormal findings in clinical trials should be verified and recorded in time to ensure the reliability of the data. The instruments, equipment, reagents and standards used in various examination items in clinical trials should have strict quality standards and ensure that they work under normal conditions. The researcher inputs the information required by the program into the eCRF, and the inspector verifies whether the filling is complete and accurate, and instructs the staff of the research center to make necessary corrections and supplements. The drug regulatory department, the institutional review committee (IRB)/ independent ethics committee (IEC), sponsor inspectors and / or inspectors may conduct systematic inspections of clinical trial-related activities and documents to evaluate whether trials are conducted in accordance with the requirements of the study program, SOP and relevant regulations (e.g. GCP, GMP), and whether trial data are recorded in a timely, true, accurate and complete manner. The inspection should be carried out by personnel who are not directly involved in the clinical trial.
  5. Statistical analysis plan： Efficacy evaluation: The primary endpoint was analyzed by Mixed Model for Repeated Measures(MMRM).And the primary endpoint analysis was based on the analysis results of Full Analysis Set(FAS) and Per Protocol Set(PPS).
Being tested
Anisodine Hydrobromide, Anisodine Hydrobromide placebo
Keywords
Migraine, Migraine Without Aura, Migraine with Aura
Medical subject headings
Migraine without Aura, Migraine with Aura, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anisodine HydrobromideDrug

    Anisodine Hydrobromide 1 mg oral tablet, twice times a day

  • Anisodine Hydrobromide placeboDrug

    Anisodine Hydrobromide Placebo 1 mg oral tablet, twice times a day

Study groups in NCT05416476
Study groupRoleWhat they receive
Anisodine HydrobromideExperimentalParticipants in this group took oral Anisodine Hydrobromide tablets 1 mg bid for 12 consecutive weeks and were followed up for 12 weeks.
Receives: Drug: Anisodine Hydrobromide
Anisodine Hydrobromide PlaceboPlacebo comparatorParticipants in this group took oral Anisodine Hydrobromide placebo tablets 1 mg bid for 12 consecutive weeks and were followed up for 12 weeks.
Receives: Drug: Anisodine Hydrobromide placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Change of Migraine Days

    The change of migraine days per 4 weeks during the 12-week treatment period compared with baseline.

    Baseline refers to the frequency of migraine attacks within the 28 days prior to randomization (baseline period, i.e., D-28 to D-1).

    Headache data were captured through an electronic diary.

    Measured: 12-week treatment period（Day 1-Day 84）

Secondary outcomes (19)

  1. The Change of Headache Attack Frequency

    The change of headache attack frequency per 4 weeks during the 12-week treatment period compared with baseline.

    Headache data were captured through an electronic diary.

    Measured: 12-week treatment period（Day 1-Day 84）

  2. The Change of Moderate / Severe Headache Days

    The change of days with moderate / severe headache per 4 weeks during the 12-week treatment period compared with baseline.

    Measured: 12-week treatment period（Day 1-Day 84）

  3. The Responder Rate of at Least 50%, 75% and 100% Reduction of Migraine Days

    The Responder Rate of at Least 50%, 75% and 100% Reduction of Migraine Days is compared with the baseline per 4 weeks during the 12-week treatment period.

    Headache data were captured through an electronic diary.

    Measured: 12-week treatment period（Day 1-Day 84）

  4. The Dose of Acute Medication Use

    Variation in the dose of medications for the acute migraine per 4 weeks during the 12-week treatment period compared with baseline. The allowed medications to treat an acute migraine include the following categories of drugs: triptans, ergots, opioids, analgesics (including acetaminophen), NSAIDs, and antiemetics.

    Data were captured through an electronic diary.

    Measured: 12-week treatment period（Day 1-Day 84）

  5. The Change of Frequency of Medications Use

    The change of frequency of medications for the acute migraine per 4 weeks during the 12-week treatment period compared with baseline. The allowed medications include the following categories of drugs: triptans, ergots, opioids, analgesics (including acetaminophen), NSAIDs, and antiemetics.

    Data were captured through an electronic diary.

    Measured: 12-week treatment period（Day 1-Day 84）

  6. The Change of Peak Headache Pain Intensity

    The change of peak headache pain intensity per 4 weeks during the 12-week treatment period compared with baseline.

    Subjects should record the maximum intensity of daily headaches and any medication used. An 11-point digital rating scale can be used instead of or in conjunction with a 4-level classified rating scale. The 11-point visual analogue scale (VAS) has 10 scales, with a "0" end and a "10" end at both ends, where 0 means no pain, and 10 means the most severe pain that is unbearable.4-level classified rating scale was used to evaluate the headache intensity of each migraine day--painless, mild, moderate, or severe.

    Headache data were captured through an electronic diary.

    Measured: 12-week treatment period（Day 1-Day 84）

  7. The Change of Average Headache Intensity

    The change of average headache intensity per 4 weeks during the 12-week treatment period compared with baseline.

    Four-point rating scale was used to evaluate the headache intensity of each migraine day--painless, mild, moderate, or severe. Migraine intensity is not recommended as the main outcome measure alone, but it is important to record the decrease in migraine intensity as an indicator of disability reduction.

    Depending on the design of the trial, subjects should be asked to record the intensity of each migraine. In addition, the 11 point visual rating scale (VAS) can be used instead or in combination with the 4-level classification rating scale. The use of VAS in clinical trials may increase the likelihood of showing differences in severity.The 11-point visual analogue scale (VAS) has 10 scales, with a "0" end and a "10" end at both ends, where 0 means no pain, and 10 means the most severe pain that is unbearable.

    Headache data were captured through an electronic diary.

    Measured: 12-week treatment period（Day 1-Day 84）

  8. The Change of Cumulative Hours of Moderate / Severe Headache

    The change of cumulative hours of moderate / severe headache per 4 weeks during the 12-week treatment period compared with baseline.

    Headache data were captured through an electronic diary.

    Measured: 12-week treatment period（Day 1-Day 84）

  9. The Change of Days without Symptoms

    The change of days without symptoms per 4 weeks during the 12-week treatment period compared with baseline.

    Days Without Symptoms are defined as the number of days without aura, prodromal symptoms, headaches, pain and subsequent symptoms. It needs to be determined by headache diary.

    Measured: 12-week treatment period（Day 1-Day 84）

  10. The Change of Headache-free Days

    The change of headache-free Days per 4 weeks during the 12-week treatment period compared with baseline.

    Headache-free days are defined as days with no headache or associated symptoms (including disability and cognitive/emotional impairment) that are directly attributable to migraine.

    Measured: 12-week treatment period（Day 1-Day 84）

  11. The Change of Migraine Disability Assessment questionnaire (mMIDAS) Score

    The change of mMIDAS score per 4 weeks during the 12-week treatment period compared with baseline.

    The mMIDAS has 5 self-assessment items that calculate the missed work days and the missed household work days in the previous month. The mMIDAS also conducts assessments of disability in family, social, and leisure activities. The mMIDAS score is the sum of the scores of the 5 items. The score is multiplied by 3 for grading and is divided into 4 severe levels: I = 0-5 (slight disability); II = 6-10 (mild disability). Disability); Grade III = Grade 11-20 (moderate disability); Grade IV = above Grade 21 (severe disability).

    Measured: 12-week treatment period（Day 1-Day 84）

  12. The Change of Headache Impact Test (HIT-6) Score

    The change of HIT-6 score per 4 weeks during the 12-week treatment period compared with baseline.

    The HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function.

    Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always).

    Measured: 12-week treatment period（Day 1-Day 84）

  13. The Change of Migraine Specific Quality of Life questionnaire(MSQ v2.1) Score

    The change of MSQ v2.1 score per 4 weeks during the 12-week treatment period compared with baseline.

    The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive assesses how migraines limit one's daily social and work-related activities; Role Function Preventive assesses how migraines prevent these activities; and the Emotional Function domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from "none of the time" to "all of the time." Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life.

    Measured: 12-week treatment period（Day 1-Day 84）

  14. The Change of The Patient Global Impression of Change (PGIC) Score

    The change of PGIC score per 4 weeks during the 12-week treatment period compared with baseline.

    The PGIC is a single item questionnaire used to measure the participant's impression of overall change in migraine since the first dose of study medication. The measure uses a 7-point rating scale with responses ranging from "very much better" to "very much worse."

    Measured: 12-week treatment period（Day 1-Day 84）

  15. The Change of Patient Health Questionnaire-9(PHQ-9) Score

    The change of PHQ-9 score per 4 weeks during the 12-week treatment period compared with baseline. PHQ-9 consists of 9 diagnostic criteria in The Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV involving depression within the last 2 weeks. Subjects were asked to indicate the frequency of 9 depressive symptoms in the last 2 weeks on a 4-point scale: 0 (none at all), 1 (a few days), 2 (more than half), and 3 (almost every day).The total score of PHQ-9 is between 0 and 27(from the best to the worst). 10-14 points may indicate moderate depression, and 15-19 points may indicate moderately severe depression; 20 to 27 points may have severe depression.

    Measured: 12-week treatment period（Day 1-Day 84）

  16. The Change of Generalized Anxiety Disorder (GAD-7) Score

    The change of GAD-7 score per 4 weeks during the 12-week treatment period compared with baseline.

    GAD-7 is a proven, self-administered and concise tool for screening and diagnosing mental health disorders, which has been tested in the field in office practice. The screening scale is easy to use and can be completed in a short time, which improves the recognition rate of anxiety disorders and facilitates diagnosis and treatment. The main statistical index of this scale is the total score, that is, the sum of item scores. The total score range of GAD-7 is 0: 21 and that of GAD-2 is 0: 6. The score of GAD-7 can be used to evaluate the severity of anxiety symptoms: 0: 4: no clinical significance: anxiety: 5: 9: mild; 10: 14: moderate; > 15: severe. When used as an assistant diagnosis of anxiety symptoms, the cut-off value of GAD-7 is greater than or equal to 10.

    Measured: 12-week treatment period（Day 1-Day 84）

  17. The Change of Functional Impairment Scale (FIS) Score

    The change of FIS score per 4 weeks during the 12-week treatment period compared with baseline.

    FIS is a four-point scale that assesses functional status and the intensity of impairment during daily activities. It can be used in conjunction with the four-point pain intensity scale and is usually completed daily and summarized over4-week intervals.

    Measured: 12-week treatment period（Day 1-Day 84）

  18. The Change of EuroQol-5 Dimension questionnaire (EQ-5D) Score

    The change of EQ-5D score per 4 weeks during the 12-week treatment period compared with baseline.

    The EQ-5D is a self-administered standardized measure of health status. It consists of 2 components - the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labelled "Best imaginable health state" and "Worst imaginable health state." The scoring range of the EQ VAS is from 0 (worst imaginable health) to 100 (best imaginable health).

    Measured: 12-week treatment period（Day 1-Day 84）

  19. The Change of Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    The change of C-SSRS score during the 12-week treatment period compared with screening period.

    The C-SSRS was designed to distinguish the domains of suicidal ideation and suicidal behavior,and the higher scores mean a worse outcome. Four constructs are measured：the severity of ideation(rated on a 5-point ordinal scale,and the higher scores mean more planned suicidal intent)，the intensity of ideation subscale(comprises 5 items, each rated on a 5-point ordinal scale), the behavior subscale(rated on a nominal scale), the lethality subscale(assesses actual attempts; actual lethality is rated on a 6-point ordinal scale, and if actual lethality is zero, potential lethality of attempts is rated on a 3-point ordinal scale).

    Reports of suicidal ideation with intent to act and reports of actual, aborted, or interrupted suicide attempts or a behavior preparatory for making an attempt indicate subjects at high risk for suicide.

    Measured: 12-week treatment period（Day 1-Day 84）

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2022
  2. Study start30 Oct 2023
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
All subjects were randomly assigned to group A (Anisodine Hydrobromide 1 mg bid) and group B (placebo 1 mg bid) according to 1:1 ratio.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
288 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05416476
Sponsor's protocol ID
2022-0399
Acronym
ATEM
Status last verified
Feb 2023
First submitted
30 Mar 2022
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lai J, Dilli E. Migraine Aura: Updates in Pathophysiology and Management. Curr Neurol Neurosci Rep. 2020 May 19;20(6):17. doi: 10.1007/s11910-020-01037-3.

    PubMed 32430657

  • GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.

    PubMed 30496104

  • GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3.

    PubMed 30353868

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anisodine Hydrobromide in people with Migraine Without Aura and Migraine With Aura, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kaiming Liu, MD & PHD (+8615068862055, 2314411@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change of Migraine Days (time frame: 12-week treatment period（Day 1-Day 84）). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05416476, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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