A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain (NCT03877718) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain
United States475 participantsStarted 2019-02-01
Plain-language summary
A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to understand and willing to give written informed consent and authorize the Health Insurance Portability and Accountability Act (HIPAA) prior to entering the study.
. Men and women with episodic migraine who meet the criteria of the International Headache Society's Headache Classification Committee for migraine with or without aura.
. Between the ages of 18 and 75 years of age, inclusive.
. A history of episodic migraine for at least 1 year.
. Maximal frequency of 8 migraine attacks per month; minimum frequency of 2 migraine attacks per month; at least 48 hours of headache-free time between migraine attacks.
. Maximum total headache days of 14 per month.
. History of migraine headache with nausea ≥ 50% of the time.
. Able and willing to complete an electronic diary (eDiary) to record the details of a migraine attack treated with investigational treatment.
Exclusion criteria
. A clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation. Such conditions may include cardiac, respiratory, hepatic, renal or metabolic diseases, peripheral vascular disease, any systemic disease, acute infection, or neurological disease (including Parkinson's Disease or other condition associated with a movement disorder), current malignancy or recent history (within 5 years) of malignancy (other than squamous cell or basal cell carcinoma) or any medical condition that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested an oral medication called CL-H1T specifically for acute migraine pain and nausea — since it's a Phase 2 study that has already completed, what do the results tell us about how safe and effective it appeared to be, and does that evidence feel strong enough to inform my own treatment options?
2The trial measured whether people were completely pain-free and nausea-free just two hours after taking the medication — is achieving full pain relief within two hours a realistic and meaningful goal for someone with my migraine pattern, and how does that compare to what my current or other available treatments can do?
3Since this was a Phase 2 trial, it was likely designed to test safety and get early signals on effectiveness in a relatively small group — does that mean there are still significant unknowns about long-term safety or how it works across different types of migraine sufferers, including people who experience aura like I might?
4The trial included participants dealing with nausea and vomiting alongside migraine pain — given that nausea is one of my biggest issues during an attack, is there a medication already approved that targets both migraine pain and nausea together, or is something like CL-H1T still the only option being explored for that combination?
5Now that this trial is completed, is CL-H1T moving toward a Phase 3 trial or any regulatory review, and should I be watching for opportunities to participate in further research, or would my doctor recommend I focus on currently approved treatments in the meantime?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects who are pain-free 2 hours after taking investigational treatment
Timeframe: 2 hours
2
Percentage of subjects who are nausea-free 2 hours after taking investigational treatment
. A positive saliva screen for alcohol or a positive urine drug screen for cocaine, narcotics, benzodiazepines, opioids, tetrahydrocannabinol (THC), barbiturates, amphetamines, or any prescription drugs unless such a positive result can be explained by stated concomitant medications.
. Regularly smoke cigarettes or use opiate analgesic drugs, benzodiazepines, ergot containing drugs, alcohol, THC, or other drugs of abuse that, at the discretion of the Investigator, may interfere with the evaluation of the endpoints in the trial.
. Unstable use of prophylactic migraine medication (eg, change of dose or type of medication) during the 30 days prior to Screening Visit.
. Subjects using monoamine oxidase-A (MAO-A) inhibitors and who cannot be washed out.
. Subjects using selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, THC, or systemic corticosteroids over the past month prior to the Screening Visit.
. Daily use of antipsychotics at least 15 days prior to randomization.