NCT03877718 - A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain | Biotech Hunter

Enrollment

475

Participants

Timeline

Start Date

February 1, 2019

Primary Completion Date

August 27, 2019

Study Completion Date

August 27, 2019

Conditions

MigrainePainNauseaVomitingAura

Interventions

DRUG

Arm 1: CL-H1T

One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 18.75 mg)

DRUG

Arm 2: CL-H1T

One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 37.5 mg)

DRUG

Arm 3: Sumatriptan Succinate 100 mg capsule

One capsule of sumatriptan succinate 100 mg

DRUG

Arm 4: Promethazine HCl 18.75 mg

One capsule of promethazine HCl 18.75 mg

DRUG

Arm 5: Promethazine HCl 37.5 mg

One capsule of promethazine HCl 37.5 mg

OTHER

Placebo

One capsule of placebo

Trial Locations (3)

Mountain View Cl inical Research, Inc., Greer

Harmony Clinical Research, Inc., North Miami Beach

Suncoast Clinical Research, Inc., New Port Richey