Migraine With or Without Aura
Conditions
Keywords
Innate Immune System, Cytokines, Cox-2, Headache, Migraine, Migraine Prevention
Brief summary
The Preventive Treatment of Migraine with Low-Dose Naltrexone and Acetaminophen Combination: A Small, Randomized, Double-Blind, and Placebo-Controlled Clinical Trial with an Open-Label Extension for None-Responders
Interventions
Twice daily
DRUGPlacebo
Twice daily
Sponsors
Allodynic Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient is a male or a female 18 years of age or older. 2. History of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version) for at least one-year with onset of migraine prior to 50 years of age. 3. Migraine-associated nausea with ≥half of migraine attacks. 4. 5-8 migraine/probable migraine headache days on average per month in the three months prior to Visit 1 and during the Baseline Period. 5. The patient agrees to refrain from taking opiate medications from Visit 1 to 7 days after the last dose of the study drug. 6. The patient is able to complete study questionnaires, comply with the study requirements and restrictions, and willing to provide written informed consent and authorize HIPAA. 7. The patient has been taking a stable dose of a medication with migraine prevention potential for at least 3 month prior to the screening visit and agrees to not start, stop, or change dosage of any medication with migraine prevention potential during the study period. (E.g., beta-blockers, calcium channel blockers, tricyclic antidepressants, anticonvulsants, selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), magnesium or riboflavin supplements at high doses, herbal preparations (e.g. feverfew or St. john's wort)), Botulinum toxin must be discontinued one year prior to Visit 1. 8. The patient agrees to forgo any elective surgery for the duration of the study. 9. The female patient who is premenopausal or postmenopausal less than 1 year, or have not had surgical sterilization (i.e., tubal ligation, partial or complete hysterectomy) must have a negative urine pregnancy test, be non-lactating, and commit to using 2 methods of adequate and reliable contraception throughout the study and for 28 days after taking the last dose of the study drug (e.g., barrier with additional spermicidal, intra-uterine device, hormonal contraception). Male patients must be surgically sterile or commit to the use of 2 different methods of birth control during the study and for 28 days after the study.
Exclusion criteria
1. Usage of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) ≥15 days/month, or ergotamine and triptans \>10 days/month, or opioids and barbiturates \>2 days/month in the 3 months prior to Visit 1 or during the Baseline Period. 2. Tension-type-like, and/or migraine-like headache on ≥15 days per month in the 3 months prior to Visit 1 or during the Baseline Period. Diagnosis of chronic migraine, cluster headache or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic migraine). 3. Regular use of the following medications for any reason: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), antipsychotic drugs, monoamine oxidase inhibitors, benzodiazepines, sleep medications, muscle relaxants, anti-emetic medications, blood thinning medications (e.g., warfarin or heparin), cannabinoids, or botulinum toxin to head and neck regions. Low-dose aspirin for cardiovascular disease prophylaxis is permitted. 4. Confounding painful conditions, (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome, etc.). 5. Diagnosis of any concurrent medical or psychiatric condition; this includes, chronic unstable debilitating diseases such as Parkinson's disease, multiple sclerosis, cancer, significant renal impairment, significant hepatic impairment, etc. 6. The patient has a history or diagnosis of moderate-to-severe hepatic or renal impairment (\>2 × the upper limit of normal \[ULN\] for alanine transaminase or aspartate transaminase. ≥1.5 × ULN for alkaline Phosphatase, bilirubin, BUN, or creatinine). (Patients with elevated bilirubin level due to Gilbert's syndrome are allowed). 7. The patient has a history within the previous 5 years of abuse of any drug, prescription, illicit, or alcohol. 8. The Female patient is pregnant, actively trying to become pregnant, or breast-feeding. The Male patient is not practicing 2 different methods of birth control with their partner during the study, and for 28 days after the investigational drug last dose or will not remain abstinent during the study, and for 28 days after the last dose. 9. The patient has known-allergy to any of the components of the investigational drug. 10. Participation in another study with an investigational drug within 30 days before Visit 1 or during the study. 11. Use of emergency care treatment more than 3 times in the previous 6 months. 12. The patient is in the opinion of the investigator, is unsuitable to participate in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Monthly Migraine Days (MMD) From Baseline to the Last 28 Days of Treatment Period. | From the 28-day baseline period to the last 28 days of the 84-days double-blinded treatment period. | Migraine with or without aura is defined according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version). Migraine headaches must be moderate or severe and lasting ≥30 minutes. When the patient falls asleep during migraine and wakes up without it, duration of the attack is reckoned until the time of awakening). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With More Than 50% Improvement in the Mean Monthly Migraine Days (MMDs) | From the 28-day baseline period to the last 28 days of the 84-days double-blinded treatment period. | MMD stands for change in Monthly Migraine Days from 28-day baseline to the last 28 days of the double-blind treatment period |
| The Number of Participants With More Than 75% Improvement in the Mean Monthly Migraine Days (MMDs) | From the28-day baseline period to the last 28 days of the 84-day treatment period. | — |
| The Number of Participants With 100% Improvement in Mean MMD in the Last 28 Days Double-blinded Treatment Period. | From the 28-day baseline period to the last 28 days of the 84-day treatment period. | — |
| Mean Monthly Acute Migraine Medication Treatment Days Change From Baseline to Last 28 Days of Treatment | From the 28-day baseline period to the last 28 days of the 84-day treatment period. | — |
| The Change in HIT-6 From Baseline to Last 28 Days of Treatment | From the 28-day baseline period to the last 28 days of the 84-day treatment period. | HIT-6 - headache impact test - was designed to provide a global measure of adverse headache impact. Score range is 36-78, Score ≥ 60 - a very severe impact on life, scored ≤ 49 little to no impact on life. The percent responders were calculated as follows: the change from baseline score divided by the score at the baseline minus 36. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Change in Mean PIRS-20 From Baseline to Last 7 Days of Treatment. | From baseline to month 3 of the treatment period. | Average of PIRS-20, (0-60 = higher with difficulty with sleep) |
| Mean Severe Headache Days Change From Baseline to Last 28 Days of Treatment | From baseline to month 3 of the treatment period. | — |
| The Number of Participants Who Had an Improvement in Patient Global Impression of Change (PGIC) at End of Treatment | From baseline to month 3 of the treatment period. | — |
| The Number of Participants Reporting Patients' Satisfaction Level | From baseline to month 3 of the treatment period. | — |
| Mean Monthly Migraine Hours Change From Baseline to Last 28 Days of Treatment | From baseline to month 3 of the treatment period. | — |
| Change in at Least Moderate Migraine Days in Treatment | From baseline to month 3 of the treatment period | — |
| The Number of Participants Who Achieved the Percentage of Response in at Least Moderate Migraine Days Baseline to Last 28 Days of Treatment | From baseline to month 3 of the treatment period. | — |
Countries
United States
Participant flow
Recruitment details
Patient recruitment was conducted in a single site in Miami, Florida.
Participants by arm
| Arm | Count |
|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination Low-Dose Naltrexone and Acetaminophen Combination: Twice daily | 6 |
| Placebo Placebo: Twice daily | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Low-Dose Naltrexone and Acetaminophen Combination | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Continuous | 41.5 years STANDARD_DEVIATION 14.3 | 39 years STANDARD_DEVIATION 10.4 | 40 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 6 Participants | 5 Participants | 11 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 4 / 6 | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Change in Monthly Migraine Days (MMD) From Baseline to the Last 28 Days of Treatment Period.
Migraine with or without aura is defined according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version). Migraine headaches must be moderate or severe and lasting ≥30 minutes. When the patient falls asleep during migraine and wakes up without it, duration of the attack is reckoned until the time of awakening).
Time frame: From the 28-day baseline period to the last 28 days of the 84-days double-blinded treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | Change in Monthly Migraine Days (MMD) From Baseline to the Last 28 Days of Treatment Period. | -5.67 days | Standard Deviation 3.2 |
| Placebo | Change in Monthly Migraine Days (MMD) From Baseline to the Last 28 Days of Treatment Period. | -3.5 days | Standard Deviation 5.56 |
p-value: 0.426795% CI: [-3.67, 8.01]Chi-squared
Secondary
Mean Monthly Acute Migraine Medication Treatment Days Change From Baseline to Last 28 Days of Treatment
Time frame: From the 28-day baseline period to the last 28 days of the 84-day treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | Mean Monthly Acute Migraine Medication Treatment Days Change From Baseline to Last 28 Days of Treatment | Baseline acute number of migraine medication treatment days | 7.67 days | Standard Deviation 2.07 |
| Low-Dose Naltrexone and Acetaminophen Combination | Mean Monthly Acute Migraine Medication Treatment Days Change From Baseline to Last 28 Days of Treatment | Acute migraine medication treatment days in last 28 days of treatment period | 2.67 days | Standard Deviation 4.32 |
| Low-Dose Naltrexone and Acetaminophen Combination | Mean Monthly Acute Migraine Medication Treatment Days Change From Baseline to Last 28 Days of Treatment | change in monthly acute migraine medication treatment days baseline to last 28 days of treatment | -5 days | Standard Deviation 5.37 |
| Placebo | Mean Monthly Acute Migraine Medication Treatment Days Change From Baseline to Last 28 Days of Treatment | Baseline acute number of migraine medication treatment days | 8.67 days | Standard Deviation 3.5 |
| Placebo | Mean Monthly Acute Migraine Medication Treatment Days Change From Baseline to Last 28 Days of Treatment | Acute migraine medication treatment days in last 28 days of treatment period | 5.5 days | Standard Deviation 3.27 |
| Placebo | Mean Monthly Acute Migraine Medication Treatment Days Change From Baseline to Last 28 Days of Treatment | change in monthly acute migraine medication treatment days baseline to last 28 days of treatment | -3.17 days | Standard Deviation 5.49 |
p-value: 0.572495% CI: [-5.1557, 8.8157]Chi-squared
Secondary
The Change in HIT-6 From Baseline to Last 28 Days of Treatment
HIT-6 - headache impact test - was designed to provide a global measure of adverse headache impact. Score range is 36-78, Score ≥ 60 - a very severe impact on life, scored ≤ 49 little to no impact on life. The percent responders were calculated as follows: the change from baseline score divided by the score at the baseline minus 36.
Time frame: From the 28-day baseline period to the last 28 days of the 84-day treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | The Change in HIT-6 From Baseline to Last 28 Days of Treatment | Baseline (Randomization visit) mean HIT-6, score | 68.5 score | Standard Deviation 5.68 |
| Low-Dose Naltrexone and Acetaminophen Combination | The Change in HIT-6 From Baseline to Last 28 Days of Treatment | HIT-6 in last 28 days of treatment, score | 47.83 score | Standard Deviation 17.69 |
| Low-Dose Naltrexone and Acetaminophen Combination | The Change in HIT-6 From Baseline to Last 28 Days of Treatment | The change in HIT-6 from baseline to last 28 days of treatment, score | -20.67 score | Standard Deviation 19.08 |
| Placebo | The Change in HIT-6 From Baseline to Last 28 Days of Treatment | Baseline (Randomization visit) mean HIT-6, score | 68.83 score | Standard Deviation 5.27 |
| Placebo | The Change in HIT-6 From Baseline to Last 28 Days of Treatment | HIT-6 in last 28 days of treatment, score | 58 score | Standard Deviation 12.08 |
| Placebo | The Change in HIT-6 From Baseline to Last 28 Days of Treatment | The change in HIT-6 from baseline to last 28 days of treatment, score | -10.83 score | Standard Deviation 12.98 |
p-value: 0.299895% CI: [-11.15, 30.83]Chi-squared
Secondary
The Number of Participants With 100% Improvement in Mean MMD in the Last 28 Days Double-blinded Treatment Period.
Time frame: From the 28-day baseline period to the last 28 days of the 84-day treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants With 100% Improvement in Mean MMD in the Last 28 Days Double-blinded Treatment Period. | 3 Participants |
| Placebo | The Number of Participants With 100% Improvement in Mean MMD in the Last 28 Days Double-blinded Treatment Period. | 1 Participants |
p-value: 0.289495% CI: [-17.2, 67.4]Chi-squared
Secondary
The Number of Participants With More Than 50% Improvement in the Mean Monthly Migraine Days (MMDs)
MMD stands for change in Monthly Migraine Days from 28-day baseline to the last 28 days of the double-blind treatment period
Time frame: From the 28-day baseline period to the last 28 days of the 84-days double-blinded treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants With More Than 50% Improvement in the Mean Monthly Migraine Days (MMDs) | 4 Participants |
| Placebo | The Number of Participants With More Than 50% Improvement in the Mean Monthly Migraine Days (MMDs) | 2 Participants |
p-value: 0.26895% CI: [-18.46, 66.83]Chi-squared
Secondary
The Number of Participants With More Than 75% Improvement in the Mean Monthly Migraine Days (MMDs)
Time frame: From the28-day baseline period to the last 28 days of the 84-day treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants With More Than 75% Improvement in the Mean Monthly Migraine Days (MMDs) | 4 Participants |
| Placebo | The Number of Participants With More Than 75% Improvement in the Mean Monthly Migraine Days (MMDs) | 1 Participants |
p-value: 0.092695% CI: [-17.2, 67.4]Chi-squared
Other Pre-specified
Change in at Least Moderate Migraine Days in Treatment
Time frame: From baseline to month 3 of the treatment period
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | Change in at Least Moderate Migraine Days in Treatment | Mean monthly at least moderate Headaches days at baseline | 8.33 days | Standard Deviation 2.73 |
| Low-Dose Naltrexone and Acetaminophen Combination | Change in at Least Moderate Migraine Days in Treatment | Mean at least moderate migraine days in the last 28 days of the treatment period | 3.67 days | Standard Deviation 5.57 |
| Low-Dose Naltrexone and Acetaminophen Combination | Change in at Least Moderate Migraine Days in Treatment | The change in at least moderate migraine days from baseline to the last 28 days of treatment period | -4.78 days | Standard Deviation 4.42 |
| Placebo | Change in at Least Moderate Migraine Days in Treatment | The change in at least moderate migraine days from baseline to the last 28 days of treatment period | -2.83 days | Standard Deviation 5.74 |
| Placebo | Change in at Least Moderate Migraine Days in Treatment | Mean monthly at least moderate Headaches days at baseline | 9 days | Standard Deviation 2.45 |
| Placebo | Change in at Least Moderate Migraine Days in Treatment | Mean at least moderate migraine days in the last 28 days of the treatment period | 6.17 days | Standard Deviation 4.54 |
p-value: 0.5246Chi-squared
Other Pre-specified
Mean Monthly Migraine Hours Change From Baseline to Last 28 Days of Treatment
Time frame: From baseline to month 3 of the treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | Mean Monthly Migraine Hours Change From Baseline to Last 28 Days of Treatment | Baseline, hours | 70.78 Hours | Standard Deviation 47.6 |
| Low-Dose Naltrexone and Acetaminophen Combination | Mean Monthly Migraine Hours Change From Baseline to Last 28 Days of Treatment | Monthly migraine hours in last 28 days of treatment, hours | 24.65 Hours | Standard Deviation 35.23 |
| Low-Dose Naltrexone and Acetaminophen Combination | Mean Monthly Migraine Hours Change From Baseline to Last 28 Days of Treatment | The change in monthly migraine hours from baseline to last 28 days of treatment, hours | -46.13 Hours | Standard Deviation 59.44 |
| Placebo | Mean Monthly Migraine Hours Change From Baseline to Last 28 Days of Treatment | Baseline, hours | 54.44 Hours | Standard Deviation 36.21 |
| Placebo | Mean Monthly Migraine Hours Change From Baseline to Last 28 Days of Treatment | Monthly migraine hours in last 28 days of treatment, hours | 37.07 Hours | Standard Deviation 38.05 |
| Placebo | Mean Monthly Migraine Hours Change From Baseline to Last 28 Days of Treatment | The change in monthly migraine hours from baseline to last 28 days of treatment, hours | -17.37 Hours | Standard Deviation 41.11 |
p-value: 0.352795% CI: [-94.5005, 36.9805]Chi-squared
Other Pre-specified
Mean Severe Headache Days Change From Baseline to Last 28 Days of Treatment
Time frame: From baseline to month 3 of the treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | Mean Severe Headache Days Change From Baseline to Last 28 Days of Treatment | The change in severe headache days from baseline to the last 28 days of the treatment period | -2.17 days | Standard Deviation 2.79 |
| Low-Dose Naltrexone and Acetaminophen Combination | Mean Severe Headache Days Change From Baseline to Last 28 Days of Treatment | Mean monthly severe headaches days at baseline | 4.83 days | Standard Deviation 1.72 |
| Low-Dose Naltrexone and Acetaminophen Combination | Mean Severe Headache Days Change From Baseline to Last 28 Days of Treatment | Mean severe headache days in the last 28 days of the treatment period | 2.67 days | Standard Deviation 3.93 |
| Placebo | Mean Severe Headache Days Change From Baseline to Last 28 Days of Treatment | The change in severe headache days from baseline to the last 28 days of the treatment period | -1.83 days | Standard Deviation 3.87 |
| Placebo | Mean Severe Headache Days Change From Baseline to Last 28 Days of Treatment | Mean monthly severe headaches days at baseline | 4.33 days | Standard Deviation 2.88 |
| Placebo | Mean Severe Headache Days Change From Baseline to Last 28 Days of Treatment | Mean severe headache days in the last 28 days of the treatment period | 2.5 days | Standard Deviation 3.02 |
p-value: 0.8649Chi-squared
Other Pre-specified
The Change in Mean PIRS-20 From Baseline to Last 7 Days of Treatment.
Average of PIRS-20, (0-60 = higher with difficulty with sleep)
Time frame: From baseline to month 3 of the treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug,
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | The Change in Mean PIRS-20 From Baseline to Last 7 Days of Treatment. | Baseline (Randomization visit) mean PIRS-20, score | 32.67 score | Standard Deviation 16.97 |
| Low-Dose Naltrexone and Acetaminophen Combination | The Change in Mean PIRS-20 From Baseline to Last 7 Days of Treatment. | PIRS-20 in last week of treatment period, score | 10 score | Standard Deviation 19.32 |
| Low-Dose Naltrexone and Acetaminophen Combination | The Change in Mean PIRS-20 From Baseline to Last 7 Days of Treatment. | The change in PIRS-20 from baseline to last week of treatment, score | -22.67 score | Standard Deviation 22.64 |
| Placebo | The Change in Mean PIRS-20 From Baseline to Last 7 Days of Treatment. | Baseline (Randomization visit) mean PIRS-20, score | 31.83 score | Standard Deviation 7.03 |
| Placebo | The Change in Mean PIRS-20 From Baseline to Last 7 Days of Treatment. | PIRS-20 in last week of treatment period, score | 20.83 score | Standard Deviation 14.39 |
| Placebo | The Change in Mean PIRS-20 From Baseline to Last 7 Days of Treatment. | The change in PIRS-20 from baseline to last week of treatment, score | -11 score | Standard Deviation 8.92 |
p-value: 0.2673Chi-squared
Other Pre-specified
The Number of Participants Reporting Patients' Satisfaction Level
Time frame: From baseline to month 3 of the treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants Reporting Patients' Satisfaction Level | Very satisfied (level 3) | 4 Participants |
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants Reporting Patients' Satisfaction Level | Satisfied or very satisfied (level 2 or 3) | 4 Participants |
| Placebo | The Number of Participants Reporting Patients' Satisfaction Level | Very satisfied (level 3) | 2 Participants |
| Placebo | The Number of Participants Reporting Patients' Satisfaction Level | Satisfied or very satisfied (level 2 or 3) | 2 Participants |
Other Pre-specified
The Number of Participants Who Achieved the Percentage of Response in at Least Moderate Migraine Days Baseline to Last 28 Days of Treatment
Time frame: From baseline to month 3 of the treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants Who Achieved the Percentage of Response in at Least Moderate Migraine Days Baseline to Last 28 Days of Treatment | ≥50% | 4 Participants |
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants Who Achieved the Percentage of Response in at Least Moderate Migraine Days Baseline to Last 28 Days of Treatment | ≥75% | 4 Participants |
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants Who Achieved the Percentage of Response in at Least Moderate Migraine Days Baseline to Last 28 Days of Treatment | ≥90% | 3 Participants |
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants Who Achieved the Percentage of Response in at Least Moderate Migraine Days Baseline to Last 28 Days of Treatment | 100% | 3 Participants |
| Placebo | The Number of Participants Who Achieved the Percentage of Response in at Least Moderate Migraine Days Baseline to Last 28 Days of Treatment | 100% | 1 Participants |
| Placebo | The Number of Participants Who Achieved the Percentage of Response in at Least Moderate Migraine Days Baseline to Last 28 Days of Treatment | ≥50% | 2 Participants |
| Placebo | The Number of Participants Who Achieved the Percentage of Response in at Least Moderate Migraine Days Baseline to Last 28 Days of Treatment | ≥90% | 1 Participants |
| Placebo | The Number of Participants Who Achieved the Percentage of Response in at Least Moderate Migraine Days Baseline to Last 28 Days of Treatment | ≥75% | 1 Participants |
Other Pre-specified
The Number of Participants Who Had an Improvement in Patient Global Impression of Change (PGIC) at End of Treatment
Time frame: From baseline to month 3 of the treatment period.
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants Who Had an Improvement in Patient Global Impression of Change (PGIC) at End of Treatment | PGIC, Change≥2 points, (%) | 4 Participants |
| Low-Dose Naltrexone and Acetaminophen Combination | The Number of Participants Who Had an Improvement in Patient Global Impression of Change (PGIC) at End of Treatment | PGIC, Change=3 points, (%) | 4 Participants |
| Placebo | The Number of Participants Who Had an Improvement in Patient Global Impression of Change (PGIC) at End of Treatment | PGIC, Change≥2 points, (%) | 2 Participants |
| Placebo | The Number of Participants Who Had an Improvement in Patient Global Impression of Change (PGIC) at End of Treatment | PGIC, Change=3 points, (%) | 2 Participants |