NCT03877718

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

A 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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: Charleston Laboratories, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain.

Detailed 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)

Conditions

• Migraine
• Pain
• Nausea
• Vomiting
• Aura

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-08-27
• Completion: 2019-08-27
• First posted: 2019-03-18
• Last updated: 2019-11-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study