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 range18 Years – 75 Years

SexALL

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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.
✕. 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:

What they're measuring

Percentage of subjects who are pain-free 2 hours after taking investigational treatment

Timeframe: 2 hours

Percentage of subjects who are nausea-free 2 hours after taking investigational treatment

Timeframe: 2 hours

Trial details

NCT IDNCT03877718

SponsorCharleston Laboratories, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-27

View on ClinicalTrials.gov More Migraine trials