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

NCT03877718 | Completed Phase 2 FDA Drug

• 1 other identifier: CL02-204
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Migraine; Pain; Nausea; Vomiting; Aura

Keywords

Acute Migraine Pain; Acute Migraine Pain, With or Without Aura; Prevention of Migraine Associated Nausea and Vomiting (MANV)

Outcome Measures

Primary Outcomes (2)

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

  2 hours

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

  2 hours

Secondary Outcomes (1)

• Percentage of subjects with no vomiting 2 hours after taking the investigational treatment

  2 hours

Study Arms (6)

Arm 1: CL-H1T

EXPERIMENTAL

Maximum dosage within a 24-hour period: One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine hydrochloride 18.75mg)

Drug: Arm 1: CL-H1T

Arm 2: CL-H1T

EXPERIMENTAL

Maximum dosage within a 24-hour period: One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 37.5mg)

Drug: Arm 2: CL-H1T

Arm 3: Sumatriptan succinate 100 mg

EXPERIMENTAL

Maximum dose within a 24 hour period: One capsule of sumatriptan succinate 100mg

Drug: Arm 3: Sumatriptan Succinate 100 mg capsule

Arm 4: Promethazine HCl 18.75 mg

EXPERIMENTAL

Maximum dose within a 24 hour period: One capsule of promethazine HCl 18.75mg

Drug: Arm 4: Promethazine HCl 18.75 mg

Arm 5: Promethazine HCl 37.5 mg

EXPERIMENTAL

Maximum dose within a 24 hour period: One capsule of promethazine HCl 37.5mg

Drug: Arm 5: Promethazine HCl 37.5 mg

Arm 6: Placebo

EXPERIMENTAL

Maximum dose within a 24 hour period: One capsule of placebo

Other: Placebo

Interventions

Arm 1: CL-H1T DRUG

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

Also known as: sumatriptan succinate 90mg/promethazine HCl 18.75mg

Arm 1: CL-H1T

Arm 2: CL-H1T DRUG

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

Also known as: sumatriptan succinate 90mg/promethazine HCl 37.5mg

Arm 2: CL-H1T

Arm 3: Sumatriptan Succinate 100 mg capsule DRUG

One capsule of sumatriptan succinate 100 mg

Also known as: Sumatriptan succinate 100 mg

Arm 3: Sumatriptan succinate 100 mg

Arm 4: Promethazine HCl 18.75 mg DRUG

One capsule of promethazine HCl 18.75 mg

Also known as: Promethazine HCl 18.75

Arm 4: Promethazine HCl 18.75 mg

Arm 5: Promethazine HCl 37.5 mg DRUG

One capsule of promethazine HCl 37.5 mg

Also known as: Promethazine HCl 37.5

Arm 5: Promethazine HCl 37.5 mg

Placebo OTHER

One capsule of placebo

Arm 6: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able to swallow a capsule whole.
• Report headache on the Headache Pain Scale at Baseline before treatment.
• Report the presence of nausea on the Nausea Scale at Baseline before treatment.
• Women of childbearing potential (WOCBP) must practice an acceptable method of birth control (acceptable methods of birth control in this study include: surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy, or a double-barrier method \[condom or diaphragm with spermicide\]). Use of intrauterine devices and hormonal contraceptives must begin at least 8 weeks prior to Screening.
• Willing and able to comply with the protocol requirements for the duration of the study.

You may not qualify if:

• 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:
• Opioids for headache ≥ 10 days during the 90 days prior to Screening Visit;
• Combination medications that contain an opioid and/or barbiturate (eg, Fiorinal®) ≥ 10 days during the 90 days prior to Screening Visit.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) or other simple medications ˃ 14 days a month during the 90 days prior to Screening Visit.
• Triptans or ergots ≥ 10 days a month during the 90 days prior to Screening Visit.
• 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.

Sponsors & Collaborators

• Charleston Laboratories, Inc: lead

Study Sites (3)

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

Location

Harmony Clinical Research, Inc.

North Miami Beach, Florida, 33162, United States

Location

Mountain View Cl inical Research, Inc.

Greer, South Carolina, 29651, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Pain; Nausea; Vomiting; Epilepsy

Interventions

Sumatriptan; Diphenhydramine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Bernard P. Schachtel, MD

  Charleston Laboratories

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 18, 2019
• Study Start: February 1, 2019
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)