TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME）
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
In this study,189 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 Tizanidine Hydrochloride in preventing migraine attacks in episodic migraine in adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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);
Type 1: Divalproex, Sodium Valproate
Type 2: Topiramate
Trial design
Design model
Parallel
Treatments tested in this trial
Tizanidine Hydrochloride
DrugTizanidine Hydrochloride 1 mg Tid for 12 consecutive weeks and were followed up for 12 weeks
Tizanidine Hydrochloride
DrugTizanidine Hydrochloride 2 mg Tid for 12 consecutive weeks and were followed up for 12 weeks
Tizanidine Hydrochloride Placebo
DrugTizanidine Hydrochloride Placebo Comparator 1 tablet Tid for 12 consecutive weeks and were followed up for 12 weeks
Treatment groups
189 Participants
are divided into 3 treatment groupsGroup A: group AExperimental treatment 1 intervention
Group B: group BExperimental treatment 1 intervention
Group C: group CPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Change of Migraine Days.
The change of migraine days per 4 weeks during the 12-week treatment period mpared 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.
Time frame
12-week treatment period（Day 1-Day 84）Secondary outcomes
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.
Time frame
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. Headache data were captured through an electronic diary.
Time frame
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.
Time frame
12-week treatment period（Day 1-Day 84）4
The Change of Frequency of Medications Use
The Change of Frequency of Medications Use \[Time Frame: 12-week treatment period（Day 1-Day 84）\] 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.
Time frame
12-week treatment period（Day 1-Day 84）Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Sichuan Credit Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov