MigrainePhase 2NCT03877718
A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain
A Phase 2 study testing Arm 1: CL-H1T, Arm 2: CL-H1T and Arm 3: Sumatriptan Succinate 100 mg capsule in people with Migraine and Pain, run by Charleston Laboratories, Inc at 3 sites in United States.
Trial summary
A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Arm 1: CL-H1T, Arm 2: CL-H1T and Arm 3: Sumatriptan Succinate 100 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 475 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2019to 27 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- History of allergic reaction or drug sensitivity to acetaminophen.
- History of extrapyramidal reaction (eg, akathisia or dystonia) to neuroleptic treatments.
- Subjects who are pregnant (positive urine hCG: Human chorionic gonadotropin test at Screening Visit) or breastfeeding.
- Use of experimental or investigational treatments and/or participation in drug clinical studies within the 6 months before the Screening Visit.
- Subjects who are employees of the Sponsor.
- Relatives of, or staff directly reporting to, the Investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mountain View Cl inical Research, Inc.
Greer, South Carolina, 29651
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Harmony Clinical Research, Inc.
North Miami Beach, Florida, 33162
About this study
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.
A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain.
Read the 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)
- Being tested
- Arm 1: CL-H1T, Arm 2: CL-H1T, Arm 3: Sumatriptan Succinate 100 mg capsule, Arm 4: Promethazine HCl 18.75 mg, Arm 5: Promethazine HCl 37.5 mg
- Keywords
- Acute Migraine Pain, Acute Migraine Pain, With or Without Aura, Prevention of Migraine Associated Nausea and Vomiting (MANV)
- Medical subject headings
- Migraine Disorders, Pain, Nausea, Vomiting, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: CL-H1TDrug
Also called sumatriptan succinate 90mg/promethazine HCl 18.75mg
One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 18.75 mg)
Arm 2: CL-H1TDrug
Also called sumatriptan succinate 90mg/promethazine HCl 37.5mg
One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 37.5 mg)
Arm 3: Sumatriptan Succinate 100 mg capsuleDrug
Also called Sumatriptan succinate 100 mg
One capsule of sumatriptan succinate 100 mg
Arm 4: Promethazine HCl 18.75 mgDrug
Also called Promethazine HCl 18.75
One capsule of promethazine HCl 18.75 mg
Arm 5: Promethazine HCl 37.5 mgDrug
Also called Promethazine HCl 37.5
One capsule of promethazine HCl 37.5 mg
PlaceboOther
One capsule of placebo
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Arm 5: Promethazine HCl 37.5 mg |
| Arm 6: Placebo | Experimental | Maximum dose within a 24 hour period: One capsule of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who are pain-free 2 hours after taking investigational treatment
Measured: 2 hours
Percentage of subjects who are nausea-free 2 hours after taking investigational treatment
Measured: 2 hours
Secondary outcomes (1)
Percentage of subjects with no vomiting 2 hours after taking the investigational treatment
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Feb 2019
- Primary completion27 Aug 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charleston Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard P. Schachtel, MD, Study chair, Charleston Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877718
- Sponsor's protocol ID
- CL02-204
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03877718
- Acronym / sponsor ID
- CL02-204
- Keywords
- Acute Migraine Pain, Acute Migraine Pain, With or Without Aura, Prevention of Migraine Associated Nausea and Vomiting (MANV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Charleston Laboratories, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CL-H1T | Experimental | Drug: Arm 1: CL-H1TMaximum dosage within a 24-hour period: One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine hydrochloride 18.75mg) |
| Arm 2: CL-H1T | Experimental | Drug: Arm 2: CL-H1TMaximum dosage within a 24-hour period: One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 37.5mg) |
| Arm 3: Sumatriptan succinate 100 mg | Experimental | Drug: Arm 3: Sumatriptan Succinate 100 mg capsuleMaximum dose within a 24 hour period: One capsule of sumatriptan succinate 100mg |
| Arm 4: Promethazine HCl 18.75 mg | Experimental | Drug: Arm 4: Promethazine HCl 18.75 mgMaximum dose within a 24 hour period: One capsule of promethazine HCl 18.75mg |
| Arm 5: Promethazine HCl 37.5 mg | Experimental | Drug: Arm 5: Promethazine HCl 37.5 mgMaximum dose within a 24 hour period: One capsule of promethazine HCl 37.5mg |
| Arm 6: Placebo | Experimental | Other: PlaceboMaximum dose within a 24 hour period: One capsule of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1: CL-H1TAlso: sumatriptan succinate 90mg/promethazine HCl 18.75mgOne capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 18.75 mg) | Drug | Arm 1: CL-H1T |
| Arm 2: CL-H1TAlso: sumatriptan succinate 90mg/promethazine HCl 37.5mgOne capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 37.5 mg) | Drug | Arm 2: CL-H1T |
| Arm 3: Sumatriptan Succinate 100 mg capsuleAlso: Sumatriptan succinate 100 mgOne capsule of sumatriptan succinate 100 mg | Drug | Arm 3: Sumatriptan succinate 100 mg |
| Arm 4: Promethazine HCl 18.75 mgAlso: Promethazine HCl 18.75One capsule of promethazine HCl 18.75 mg | Drug | Arm 4: Promethazine HCl 18.75 mg |
| Arm 5: Promethazine HCl 37.5 mgAlso: Promethazine HCl 37.5One capsule of promethazine HCl 37.5 mg | Drug | Arm 5: Promethazine HCl 37.5 mg |
| PlaceboOne capsule of placebo | Other | Arm 6: Placebo |
Primary outcome
Percentage of subjects who are pain-free 2 hours after taking investigational treatment
Time frame: 2 hours
Percentage of subjects who are nausea-free 2 hours after taking investigational treatment
Time frame: 2 hours
1 secondary outcome
Percentage of subjects with no vomiting 2 hours after taking the investigational treatment
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard P. Schachtel, MD study chair
Charleston Laboratories
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arm 1: CL-H1T, Arm 2: CL-H1T and Arm 3: Sumatriptan Succinate 100 mg capsule in people with Migraine and Pain, run by Charleston Laboratories, Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who are pain-free 2 hours after taking investigational treatment (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.