Status and phase
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About
A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain.
Full description
A Multicenter, Randomized, Double-Blind, Comparator-Controlled, Placebo-Controlled Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain, With or Without Aura, and the Prevention of Migraine-Associated Nausea and Vomiting (MANV)
Enrollment
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Volunteers
Inclusion criteria
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.
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.
Medication overuse:
Use of mini prophylaxis for menstrual migraine.
History of allergic reaction or drug sensitivity to any triptans.
History of allergic reaction or drug sensitivity to promethazine.
History of allergic reaction or drug sensitivity to acetaminophen.
History of extrapyramidal reaction (eg, akathisia or dystonia) to neuroleptic treatments.
Subjects who are pregnant (positive urine hCG: Human chorionic gonadotropin test at Screening Visit) or breastfeeding.
Use of experimental or investigational treatments and/or participation in drug clinical studies within the 6 months before the Screening Visit.
Subjects who are employees of the Sponsor.
Relatives of, or staff directly reporting to, the Investigator.
Primary purpose
Allocation
Interventional model
Masking
475 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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