Healthy Volunteers, Tension-type Headache
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to describe pain relief in TTH with Neosaldina treatment.
Detailed description
This is an observational, non-interventional and prospective study of healthy participants with episodic TTH who have already been treated with Neosaldina according to regular clinical practice. This study will assess the pain intensity and pain relief of TTH after the uptake of Neosaldina. This study will enroll approximately 317 participants. All participants will be enrolled into one observational group: • Neosaldina Investigators will assess participants from the time of enrolment through the completion of observation period up to 6 months. Each participant will be assessed up to 45 days after first dose. The data will be collected from medical charts and during routine follow up visits. The data from participants will be collected through a self-administered questionnaire using a mobile phone. All the participants will be instructed to insert the data in an application, downloaded in their phone whenever they will have an episode of TTH and use Neosaldina. This multi-center trial will be conducted in Brazil. The overall duration of observation period in this study is approximately 6 months. Participants will be contacted by telephone on Days 15 and 30 for a follow up and will make a final visit on Day 45.
Interventions
None listed
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Confirmed diagnosis of episodic TTH, as determined by the International Classification of Headache Disorders. 2. Healthy participants who was prescribed 2 tablets of Neosaldina for episodic TTH. 3. Receive treatment according to the Summary of Product Characteristics for Neosaldina. 4. Has access to a mobile phone with the ability to download the app with the study questionnaire. 5. Has at least 1 episode of TTH per month.
Exclusion criteria
1. Currently participates or plans to participate in an interventional clinical trial. 2. Has hypersensitivity or intolerance to dypirone (or pyrazolonic derivatives) or other components of the product formula. 3. Has history of migraine, cluster headaches, chronic TTH or any other type of primary headache other than episodic TTH. 4. Has suspected secondary headache. 5. Has serious comorbidities (hypertension, blood dyscrasias, malignant neoplasms, any type of hepatitis or kidney disease, disorders of the hematopoietic system, insufficient function of the bone marrow or certain metabolic diseases, such as hepatic porphyria or congenital deficiency of glucose-6-phosphate dehydrogenase) or taking any medications which might confound the pharmacological effects of the study drug (example immunosuppressive drugs, and beta blockers, anticonvulsivants, antidepressants) within 30 days before the start of study. 6. Women who may be pregnant or breastfeeding during the course of the study. 7. Has history of alcohol abuse or other drugs according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 8. Has mental incapacity, unwillingness or language barriers unable to understand the guidelines specified in this protocol. 9. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Time-weighted Sum of Pain Intensity Difference From Baseline (0 Hour) to 2 Hours (SPID 0-2) Post-dose | Baseline (0 hour) up to 2 hours post-dose | Sum of pain intensity difference (SPID) was calculated as time-weighted sum of the visual analogue scale (VAS) differences over 2 hour period. Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). Pain intensity difference (PID) was the difference between baseline pain intensity (prior to the dosing) and current pain intensity at assessment. Total possible score ranges from -720 (worst) to 120 (best) for SPID 0-2. A higher value in SPID indicated greater pain relief. This outcome was recorded at 15-minutes intervals for the first 60 minutes, followed by 30 minutes from 1 to 2 hours after Neosaldina administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction | Each episodic TTH (Day 1 up to Day 45) | Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). |
| Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR) | Each episodic TTH (Day 1 to Day 45) | The relief of pain intensity was assessed by the PID% in each time point. Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). PID was the difference between baseline pain intensity (prior to the dosing) and current pain intensity at assessment. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief which was reduction of at least 1 point on pain intensity) according to the pain intensity reported at the time points 0, 15, 30, 45, 60, 90 and 120 minutes after Neosaldina administration. |
| Cohort 1: Mean Duration of PR for Participants With Second Neosaldina Intake | Each episodic TTH (Day 1 up to Day 45) | Duration of PR was defined by the time of second intake of study medication. |
| Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, and 120 minutes | Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). Percentage of participants are reported who had no pain relief and who achieved a reduction of at least 1 point pain in intensity for each time interval. |
| Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Day 45 | Overall satisfaction of participants was assessed by the physicians based on Physician Global Assessment measured on a 5-point scale for TTH as: 0 (very satisfied); 1 (satisfied); 2 (indifferent); 3 (dissatisfied); 4 (very dissatisfied). |
| Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration | Day 1 up to Day 45 | — |
| Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Day 45 | Overall satisfaction of participants was assessed by the participants based on Patient Global Assessment measured on a 5-point scale for TTH as: 0 (very satisfied); 1 (satisfied); 2 (indifferent); 3 (dissatisfied); 4 (very dissatisfied). |
Countries
Brazil
Participant flow
Recruitment details
Participants took part in the study at 5 investigative sites in Brazil from 20 December 2018 to 19 August 2019.
Pre-assignment details
Healthy participants with episodic tension-type headache (TTH) who had at least 1 reported headache and Neosaldina intake in mobile phone application enrolled in Cohort 1. Participants from Cohort 1 who had pain intensity reported at 0 and 120 minutes after Neosaldina intake/0 pain before 120 minutes in first headache report enrolled in Cohort 2.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (All Participants): Neosaldina All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment. | 216 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Cohort 1 | Adverse Event | 1 | 0 |
| Cohort 2 | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Cohort 1 (All Participants): Neosaldina |
|---|---|
| Age, Continuous | 38.56 years STANDARD_DEVIATION 11.97 |
| Household Income 0.5 to 1 minimum wage | 4 Participants |
| Household Income 10 to 20 minimum wage | 43 Participants |
| Household Income 1 to 2 minimum wage | 15 Participants |
| Household Income 20 minimum wage | 7 Participants |
| Household Income 2 to 3 minimum wage | 49 Participants |
| Household Income 3 to 5 minimum wage | 43 Participants |
| Household Income 5 to 10 minimum wage | 45 Participants |
| Household Income No income | 1 Participants |
| Household Income Not reported | 8 Participants |
| Household Income Unknown | 1 Participants |
| Occupation Employed | 130 Participants |
| Occupation Employed and student | 52 Participants |
| Occupation Homemaker | 13 Participants |
| Occupation Retired | 8 Participants |
| Occupation Student | 10 Participants |
| Occupation Unemployed | 2 Participants |
| Occupation Unknown | 1 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 18 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 11 Participants |
| Race/Ethnicity, Customized White | 178 Participants |
| Region of Enrollment Brazil | 216 Participants |
| Sex: Female, Male Female | 172 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 216 |
| other Total, other adverse events | 6 / 216 |
| serious Total, serious adverse events | 0 / 216 |
Outcome results
Primary
Cohort 2: Time-weighted Sum of Pain Intensity Difference From Baseline (0 Hour) to 2 Hours (SPID 0-2) Post-dose
Sum of pain intensity difference (SPID) was calculated as time-weighted sum of the visual analogue scale (VAS) differences over 2 hour period. Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). Pain intensity difference (PID) was the difference between baseline pain intensity (prior to the dosing) and current pain intensity at assessment. Total possible score ranges from -720 (worst) to 120 (best) for SPID 0-2. A higher value in SPID indicated greater pain relief. This outcome was recorded at 15-minutes intervals for the first 60 minutes, followed by 30 minutes from 1 to 2 hours after Neosaldina administration.
Time frame: Baseline (0 hour) up to 2 hours post-dose
Population: All participants from Cohort 1 with TTH who reported at least one headache episode and Neosaldina intake in the mobile phone application during the study and who reported pain intensity at 0 and 120 minutes after Neosaldina intake or reported 0 pain before 120 minutes in their first headache report, and with primary endpoint data available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohort 2: Time-weighted Sum of Pain Intensity Difference From Baseline (0 Hour) to 2 Hours (SPID 0-2) Post-dose | -210 units on a scale |
Secondary
Cohort 1: Mean Duration of PR for Participants With Second Neosaldina Intake
Duration of PR was defined by the time of second intake of study medication.
Time frame: Each episodic TTH (Day 1 up to Day 45)
Population: All participants with TTH who reported at least one headache episode and Neosaldina intake in the mobile phone application during the study. Here overall number of participants analyzed were those who had more than one headache in the same day and were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohort 1: Mean Duration of PR for Participants With Second Neosaldina Intake | 5.16 hours | Standard Deviation 2.26 |
Secondary
Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration
Time frame: Day 1 up to Day 45
Population: The safety analysis set included all participants with TTH who reported at least one headache episode and Neosaldina intake in the mobile phone application.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration | 6 Participants |
Secondary
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction
Overall satisfaction of participants was assessed by the participants based on Patient Global Assessment measured on a 5-point scale for TTH as: 0 (very satisfied); 1 (satisfied); 2 (indifferent); 3 (dissatisfied); 4 (very dissatisfied).
Time frame: Day 45
Population: All participants in Cohort (C) 1 with TTH who had greater than or equal to (\>=1) headache/Neosaldina intake in mobile application and from C1 in C2 who had pain intensity at 0, 120 minutes after Neosaldina intake/0 pain before 120 minutes in first headache report, and with primary endpoint data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Very satisfied | 91 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Satisfied | 99 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Indifferent | 6 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Dissatisfied | 7 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Very dissatisfied | 2 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Unknown | 11 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Very dissatisfied | 1 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Very satisfied | 63 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Dissatisfied | 3 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Satisfied | 59 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Unknown | 7 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction | Indifferent | 5 Participants |
Secondary
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction
Overall satisfaction of participants was assessed by the physicians based on Physician Global Assessment measured on a 5-point scale for TTH as: 0 (very satisfied); 1 (satisfied); 2 (indifferent); 3 (dissatisfied); 4 (very dissatisfied).
Time frame: Day 45
Population: All participants in Cohort (C) 1 with TTH who had \>=1 headache/Neosaldina intake in mobile application and from C1 in C2 who had pain intensity at 0, 120 minutes after Neosaldina intake/0 pain before 120 minutes in first headache report, and with primary endpoint data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Very satisfied | 94 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Satisfied | 98 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Indifferent | 8 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Dissatisfied | 3 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Very dissatisfied | 2 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Unknown | 11 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Very dissatisfied | 1 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Very satisfied | 62 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Dissatisfied | 3 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Satisfied | 62 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Unknown | 7 Participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction | Indifferent | 3 Participants |
Secondary
Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval
Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). Percentage of participants are reported who had no pain relief and who achieved a reduction of at least 1 point pain in intensity for each time interval.
Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, and 120 minutes
Population: All participants in Cohort(C)1 with TTH who had \>=1 headache/Neosaldina intake in mobile application, from C1 in C2 who had pain intensity at 0, 120 minutes after Neosaldina intake,0 pain before 120 minutes in first headache report, with primary endpoint data. Here overall number of participants analyzed are those who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | No pain relief | 5.92 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 15 minutes | 43.42 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 30 minutes | 27.63 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 45 minutes | 11.18 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 60 minutes | 7.89 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 90 minutes | 2.63 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 120 minutes | 1.32 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | No pain relief | 2.17 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 60 minutes | 6.52 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 15 minutes | 45.65 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 120 minutes | 1.45 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 30 minutes | 28.26 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 90 minutes | 5.07 percentage of participants |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Percentage of Participants Who Achieved a Reduction of at Least 1 Point Pain in Intensity for Each Time Interval | At 45 minutes | 10.87 percentage of participants |
Secondary
Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction
Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain).
Time frame: Each episodic TTH (Day 1 up to Day 45)
Population: All participants in Cohort (C) 1 with TTH who had \>=1 headache/Neosaldina intake in mobile application and from C1 in C2 who had pain intensity at 0, 120 minutes after Neosaldina intake/0 pain before 120 minutes in first headache report, and with primary endpoint data. Overall number analyzed are those who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction | 45.36 minutes | Standard Deviation 26.63 |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction | 51.36 minutes | Standard Deviation 31.89 |
Secondary
Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR)
The relief of pain intensity was assessed by the PID% in each time point. Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain). PID was the difference between baseline pain intensity (prior to the dosing) and current pain intensity at assessment. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief which was reduction of at least 1 point on pain intensity) according to the pain intensity reported at the time points 0, 15, 30, 45, 60, 90 and 120 minutes after Neosaldina administration.
Time frame: Each episodic TTH (Day 1 to Day 45)
Population: All participants in Cohort (C) 1 with TTH who had \>=1 headache/Neosaldina intake in mobile application and from C1 in C2 who had pain intensity at 0, 120 minutes after Neosaldina intake/0 pain before 120 minutes in first headache report, and with primary endpoint data. Overall number analyzed are those who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR) | 30.31 minutes | Standard Deviation 20.57 |
| Cohort 2 (Participants From Cohort 1): Neosaldina | Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR) | 31.11 minutes | Standard Deviation 22.34 |