Acute Migraine
Conditions
Brief summary
This is a randomised, placebo controlled, double blind, crossover proof of concept study to investigate the efficacy and safety of oral LAT8881 in acute migraine, with or without aura.
Detailed description
Subjects enrolled in the study will be randomised to receive investigational medicinal product (LAT8881 60 mg or placebo), to be taken at the onset (within one hour from the onset of pain) of a migraine headache of moderate to severe intensity \[Numeric rating scale greater than 4\]. Rescue medication should not be taken until at least 2 hours post dose. Subjects will be given a single dose of either active or placebo, to treat one migraine headache. After treatment of one migraine headache (or a maximum 28 days) the subject will return to the clinic for re-evaluation and crossover to the second treatment. After treatment of one migraine headache in the second treatment period or a maximum of 28 days from commencement of the second treatment period, the subject will return to the clinic for re-evaluation. An End of study visit (telephone) will occur 7 days after the end of the second treatment period.
Interventions
DRUGLAT8881
Two 30 mg capsules of LAT8881
DRUGPlacebo
Two capsules of placebo
Sponsors
Lateral Pharma Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomised assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females aged 18 to 75 years at the time of consent 2. Diagnosis of episodic migraine headache at least 12 months ago with or without aura as defined in International Classification of Headache-3 3. Onset of migraine headache before age 50 4. Medical history of 2 - 8 migraine headache attacks per month for the previous 12 months; ≥ 75% of attacks progress to moderate or severe pain within 2 hours (ie, rapidly-escalating) 5. Minimum 48 hours on average between migraine headache attacks 6. Acute headache medication on ≤ 14 days/month in the 3 months prior to screening 7. Willing and able to comply with all study procedures including completion of a headache diary and a migraine diary on the day of a migraine headache
Exclusion criteria
1. Unable to distinguish migraine from other primary headache conditions 2. Average of 15 or more headache (migraine or nonmigraine) days per month or history of more than 25% of headaches occurring at time of wakening (wake up headaches) 3. History of aura lasting more than 60 minutes 4. History of vomiting within 2 hours of onset of a migraine headache in more than 25% of migraine headaches 5. Medication overuse headache, defined as: 1. use of opioids, triptans or ergot alkaloids or any combination of these medications for treatment of headaches 10 or more days per month during the 90 days prior to screening OR 2. Non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics for treatment of headaches on more than 14 days per month during the 90 days prior to screening 6. Recent (3 years) history of frequent or chronic hemiplegic/ basilar migraine, tension headache, retinal migraine, ophthalmoplegic migraine as per ICHD classification, or treatment resistant atypical migraine 7. Hospital admission for status intractable migraine or medication overuse headache within 6 months of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose | Change in migraine headache pain score, using an 11-point numeric rating scale (NRS), (0 = none, 10 = worst imaginable), Pain is recorded in a subject diary and should reflect the subject's pain at the time of recording. A reduction in NRS score indicates a reduction in pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose | Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms). A larger negative number represents a greater reduction in symptom intensity |
| Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose | Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms). A larger negative number represents a greater reduction in symptom intensity. |
| The Percentage of Subjects Achieving no Headache Pain | 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose | Defined as having no migraine headache pain |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LAT8881, Then Placebo Subjects took LAT8881 60 mg (2 capsules) at the onset of a migraine of moderate to severe intensity. After treatment of one migraine (or a maximum of 28 days), subjects took 2 placebo capsules at the onset of a migraine of moderate to severe intensity. | 10 |
| Placebo, Then LAT8881 Subjects took 2 placebo capsules at the onset of a migraine of moderate to severe intensity. After treatment of one migraine (or a maximum of 28 days), subjects took LAT8881 60 mg (2 capsules) at the onset of a migraine of moderate to severe intensity. | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | LAT8881, Then Placebo | Placebo, Then LAT8881 | Total |
|---|---|---|---|
| Age, Continuous | 38.8 years STANDARD_DEVIATION 9.61 | 41.2 years STANDARD_DEVIATION 13.64 | 40.0 years STANDARD_DEVIATION 11.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 11 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Australia | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 3 / 17 | 3 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
Change in migraine headache pain score, using an 11-point numeric rating scale (NRS), (0 = none, 10 = worst imaginable), Pain is recorded in a subject diary and should reflect the subject's pain at the time of recording. A reduction in NRS score indicates a reduction in pain intensity.
Time frame: 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 1.5 hours | -0.9 score on a scale | Standard Deviation 2.36 |
| Active | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 4 hours | -2.7 score on a scale | Standard Deviation 2.96 |
| Active | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 1 hour | -0.8 score on a scale | Standard Deviation 1.83 |
| Active | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 8 hours | -4.6 score on a scale | Standard Deviation 2.31 |
| Active | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 2 hours | -1.8 score on a scale | Standard Deviation 3.12 |
| Active | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 24 hours | -5.8 score on a scale | Standard Deviation 1.87 |
| Active | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 0.5 hours | 0 score on a scale | Standard Deviation 1.1 |
| Placebo | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 24 hours | -5.6 score on a scale | Standard Deviation 2.8 |
| Placebo | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 0.5 hours | 0.2 score on a scale | Standard Deviation 1.33 |
| Placebo | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 1 hour | -0.2 score on a scale | Standard Deviation 1.68 |
| Placebo | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 1.5 hours | -0.5 score on a scale | Standard Deviation 1.84 |
| Placebo | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 2 hours | -0.8 score on a scale | Standard Deviation 2.63 |
| Placebo | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 4 hours | -2.2 score on a scale | Standard Deviation 3.56 |
| Placebo | Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) | Change from baseline at 8 hours | -3.7 score on a scale | Standard Deviation 3.39 |
Comparison: Change from baseline at 0.5 hoursp-value: 0.973395% CI: [-1.23, 1.19]Mixed Models Analysis
Comparison: Change from baseline at 1 hour. The change from baseline at 1 hour was extracted from the mixed model analysis including all time points.p-value: 0.494295% CI: [-1.64, 0.79]Mixed Models Analysis
Comparison: Change from baseline at 1.5 hours. The change from baseline at 1.5 hours was extracted from the mixed model analysis including all time points.p-value: 0.686695% CI: [-1.46, 0.97]Mixed Models Analysis
Comparison: Change from baseline at 2 hours. The change from baseline at 2 hours was extracted from the mixed model analysis including all time points.p-value: 0.148895% CI: [-2.11, 0.32]Mixed Models Analysis
Comparison: Change from baseline at 4 hours. The change from baseline at 4 hours was extracted from the mixed model analysis including all time points.p-value: 0.564495% CI: [-1.57, 0.86]Mixed Models Analysis
Comparison: Change from baseline at 8 hours, The change from baseline at 8 hours was extracted from the mixed model analysis including all time points.p-value: 0.256195% CI: [-1.91, 0.51]Mixed Models Analysis
Comparison: Change from baseline at 24 hours. The change from baseline at 24 hours was extracted from the mixed model analysis including all time points.p-value: 0.987595% CI: [-1.22, 1.2]Mixed Models Analysis
Secondary
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms). A larger negative number represents a greater reduction in symptom intensity.
Time frame: 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from base at 1.5 hours | -1.2 score on a scale | Standard Deviation 3.06 |
| Active | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 4 hours | -2.6 score on a scale | Standard Deviation 3.58 |
| Active | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 1 hour | -1.1 score on a scale | Standard Deviation 2.33 |
| Active | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 8 hours | -3.9 score on a scale | Standard Deviation 2.69 |
| Active | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 2 hours | -1.5 score on a scale | Standard Deviation 3.46 |
| Active | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 24 hours | -5.2 score on a scale | Standard Deviation 2.01 |
| Active | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 0.5 hours | -0.5 score on a scale | Standard Deviation 2.03 |
| Placebo | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 24 hours | -5.0 score on a scale | Standard Deviation 2.78 |
| Placebo | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 0.5 hours | -0.1 score on a scale | Standard Deviation 1.6 |
| Placebo | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 1 hour | -0.6 score on a scale | Standard Deviation 2.06 |
| Placebo | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from base at 1.5 hours | -1.2 score on a scale | Standard Deviation 2.86 |
| Placebo | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 2 hours | -1.5 score on a scale | Standard Deviation 3.16 |
| Placebo | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 4 hours | -2.8 score on a scale | Standard Deviation 3.68 |
| Placebo | Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) | Change from baseline at 8 hours | -4.0 score on a scale | Standard Deviation 3.26 |
Secondary
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms). A larger negative number represents a greater reduction in symptom intensity
Time frame: 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 0.5 hours | -0.3 score on a scale | Standard Deviation 2.24 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 1 hour | -0.9 score on a scale | Standard Deviation 2.87 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 1.5 hours | -1.0 score on a scale | Standard Deviation 3.93 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 2 hours | -1.6 score on a scale | Standard Deviation 4.02 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 4 hours | -2.1 score on a scale | Standard Deviation 4.3 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 8 hours | -4.3 score on a scale | Standard Deviation 3.32 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 24 hours | -4.9 score on a scale | Standard Deviation 3.04 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 0.5 hours | -0.2 score on a scale | Standard Deviation 0.75 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 1 hour | -0.9 score on a scale | Standard Deviation 1.91 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 1.5 hours | -0.8 score on a scale | Standard Deviation 2.08 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 2 hours | -1.3 score on a scale | Standard Deviation 2.52 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 4 hours | -2.1 score on a scale | Standard Deviation 2.7 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 8 hours | -3.8 score on a scale | Standard Deviation 2.52 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 24 hours | -4.6 score on a scale | Standard Deviation 2.39 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 0.5 hours | 0.1 score on a scale | Standard Deviation 0.89 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 1 hour | -0.6 score on a scale | Standard Deviation 2.09 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 1.5 hours | -0.5 score on a scale | Standard Deviation 2.19 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 2 hours | -0.2 score on a scale | Standard Deviation 2.61 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 4 hours | -0.6 score on a scale | Standard Deviation 2.53 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 8 hours | -1.8 score on a scale | Standard Deviation 2.48 |
| Active | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 24 hours | -2.3 score on a scale | Standard Deviation 2.35 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 2 hours | -0.9 score on a scale | Standard Deviation 2.93 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 0.5 hours | -0.1 score on a scale | Standard Deviation 1.05 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 4 hours | -1.8 score on a scale | Standard Deviation 3.05 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 1 hour | -0.6 score on a scale | Standard Deviation 1.28 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 4 hours | -2.4 score on a scale | Standard Deviation 3.68 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 1.5 hours | -1.0 score on a scale | Standard Deviation 1.7 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 1.5 hours | -0.8 score on a scale | Standard Deviation 1.95 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 2 hours | -1.0 score on a scale | Standard Deviation 2 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 8 hours | -3.6 score on a scale | Standard Deviation 3.54 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 4 hours | -2.1 score on a scale | Standard Deviation 2.41 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 24 hours | -2.6 score on a scale | Standard Deviation 2.89 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 8 hours | -2.8 score on a scale | Standard Deviation 3.6 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 24 hours | -4.4 score on a scale | Standard Deviation 3.12 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in nausea at 24 hours | -3.6 score on a scale | Standard Deviation 2.89 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 2 hours | -0.7 score on a scale | Standard Deviation 2.31 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 0.5 hours | 0.2 score on a scale | Standard Deviation 1.07 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 0.5 hours | -0.2 score on a scale | Standard Deviation 1.68 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 1 hour | 0.0 score on a scale | Standard Deviation 1.46 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 8 hours | -2.3 score on a scale | Standard Deviation 2.91 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in photophobia at 1.5 hours | -0.8 score on a scale | Standard Deviation 2.59 |
| Placebo | Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) | Change in phonophobia at 1 hour | -0.4 score on a scale | Standard Deviation 1.73 |
Secondary
The Percentage of Subjects Achieving no Headache Pain
Defined as having no migraine headache pain
Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose
Population: Per protocol population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active | The Percentage of Subjects Achieving no Headache Pain | 1.5 hours | 0 Participants |
| Active | The Percentage of Subjects Achieving no Headache Pain | 4 hours | 2 Participants |
| Active | The Percentage of Subjects Achieving no Headache Pain | 1 hour | 0 Participants |
| Active | The Percentage of Subjects Achieving no Headache Pain | 8 hours | 6 Participants |
| Active | The Percentage of Subjects Achieving no Headache Pain | 2 hours | 2 Participants |
| Active | The Percentage of Subjects Achieving no Headache Pain | 24 hours | 11 Participants |
| Active | The Percentage of Subjects Achieving no Headache Pain | 0.5 hours | 0 Participants |
| Placebo | The Percentage of Subjects Achieving no Headache Pain | 24 hours | 12 Participants |
| Placebo | The Percentage of Subjects Achieving no Headache Pain | 0.5 hours | 0 Participants |
| Placebo | The Percentage of Subjects Achieving no Headache Pain | 1 hour | 0 Participants |
| Placebo | The Percentage of Subjects Achieving no Headache Pain | 1.5 hours | 0 Participants |
| Placebo | The Percentage of Subjects Achieving no Headache Pain | 2 hours | 0 Participants |
| Placebo | The Percentage of Subjects Achieving no Headache Pain | 4 hours | 2 Participants |
| Placebo | The Percentage of Subjects Achieving no Headache Pain | 8 hours | 6 Participants |