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

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ClinicalTrials.gov Identifier: NCT03877718
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Charleston Laboratories, Inc

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

Condition or disease Intervention/treatment Phase
Migraine Pain Nausea Vomiting Aura Drug: Arm 1: CL-H1T Drug: Arm 2: CL-H1T Drug: Arm 3: Sumatriptan Succinate 100 mg capsule Drug: Arm 4: Promethazine HCl 18.75 mg Drug: Arm 5: Promethazine HCl 37.5 mg Other: Placebo Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: CL-H1T
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
One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 18.75 mg)
Other Name: sumatriptan succinate 90mg/promethazine HCl 18.75mg

Experimental: Arm 2: CL-H1T
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
One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 37.5 mg)
Other Name: sumatriptan succinate 90mg/promethazine HCl 37.5mg

Experimental: Arm 3: Sumatriptan succinate 100 mg
Maximum dose within a 24 hour period: One capsule of sumatriptan succinate 100mg
Drug: Arm 3: Sumatriptan Succinate 100 mg capsule
One capsule of sumatriptan succinate 100 mg
Other Name: Sumatriptan succinate 100 mg

Experimental: Arm 4: Promethazine HCl 18.75 mg
Maximum dose within a 24 hour period: One capsule of promethazine HCl 18.75mg
Drug: Arm 4: Promethazine HCl 18.75 mg
One capsule of promethazine HCl 18.75 mg
Other Name: Promethazine HCl 18.75

Experimental: Arm 5: Promethazine HCl 37.5 mg
Maximum dose within a 24 hour period: One capsule of promethazine HCl 37.5mg
Drug: Arm 5: Promethazine HCl 37.5 mg
One capsule of promethazine HCl 37.5 mg
Other Name: Promethazine HCl 37.5

Experimental: Arm 6: Placebo
Maximum dose within a 24 hour period: One capsule of placebo
Other: Placebo
One capsule of placebo




Primary Outcome Measures :
  1. Percentage of subjects who are pain-free 2 hours after taking investigational treatment [ Time Frame: 2 hours ]
  2. Percentage of subjects who are nausea-free 2 hours after taking investigational treatment [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Percentage of subjects with no vomiting 2 hours after taking the investigational treatment [ Time Frame: 2 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Between the ages of 18 and 75 years of age, inclusive.
  4. A history of episodic migraine for at least 1 year.
  5. 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.
  6. Maximum total headache days of 14 per month.
  7. History of migraine headache with nausea ≥ 50% of the time.
  8. Able and willing to complete an electronic diary (eDiary) to record the details of a migraine attack treated with investigational treatment.
  9. Able to swallow a capsule whole.
  10. Report headache on the Headache Pain Scale at Baseline before treatment.
  11. Report the presence of nausea on the Nausea Scale at Baseline before treatment.
  12. 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.
  13. Willing and able to comply with the protocol requirements for the duration of the study.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Unstable use of prophylactic migraine medication (eg, change of dose or type of medication) during the 30 days prior to Screening Visit.
  5. Subjects using monoamine oxidase-A (MAO-A) inhibitors and who cannot be washed out.
  6. 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.
  7. Daily use of antipsychotics at least 15 days prior to randomization.
  8. Medication overuse:

    1. Opioids for headache ≥ 10 days during the 90 days prior to Screening Visit;
    2. Combination medications that contain an opioid and/or barbiturate (eg, Fiorinal®) ≥ 10 days during the 90 days prior to Screening Visit.
    3. Nonsteroidal anti-inflammatory drugs (NSAIDs) or other simple medications ˃ 14 days a month during the 90 days prior to Screening Visit.
    4. Triptans or ergots ≥ 10 days a month during the 90 days prior to Screening Visit.
  9. Use of mini prophylaxis for menstrual migraine.
  10. History of allergic reaction or drug sensitivity to any triptans.
  11. History of allergic reaction or drug sensitivity to promethazine.
  12. History of allergic reaction or drug sensitivity to acetaminophen.
  13. History of extrapyramidal reaction (eg, akathisia or dystonia) to neuroleptic treatments.
  14. Subjects who are pregnant (positive urine hCG: Human chorionic gonadotropin test at Screening Visit) or breastfeeding.
  15. Use of experimental or investigational treatments and/or participation in drug clinical studies within the 6 months before the Screening Visit.
  16. Subjects who are employees of the Sponsor.
  17. Relatives of, or staff directly reporting to, the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877718


Contacts
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Contact: Bernard P. Schachtel, MD 561 500 6468 bschachtel@charlestonlabs.com

Locations
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United States, Florida
Suncoast Clinical Research, Inc. Recruiting
New Port Richey, Florida, United States, 34652
Contact: Cathy Barnes, MD         
Harmony Clinical Research, Inc. Recruiting
North Miami Beach, Florida, United States, 33162
Contact: Giselle Debs-Perez, MD         
United States, South Carolina
Mountain View Cl inical Research, Inc. Recruiting
Greer, South Carolina, United States, 29651
Contact: Thomas Victor Ballard, MD         
Sponsors and Collaborators
Charleston Laboratories, Inc
Investigators
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Study Chair: Bernard P. Schachtel, MD Charleston Laboratories

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Responsible Party: Charleston Laboratories, Inc
ClinicalTrials.gov Identifier: NCT03877718     History of Changes
Other Study ID Numbers: CL02-204
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Charleston Laboratories, Inc:
Acute Migraine Pain
Acute Migraine Pain, With or Without Aura
Prevention of Migraine Associated Nausea and Vomiting (MANV)

Additional relevant MeSH terms:
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Sumatriptan
Migraine Disorders
Nausea
Vomiting
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Promethazine
Diphenhydramine
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local