Trial Outcomes & Findings for A Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-type Headaches (TTH) in Healthy Participants (NCT NCT03666858)

Last Updated: 2021-06-02

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

216 participants

Primary outcome timeframe

Baseline (0 hour) up to 2 hours post-dose

Results posted on

2021-06-02

Participant Flow

Participants took part in the study at 5 investigative sites in Brazil from 20 December 2018 to 19 August 2019.

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.

Participant milestones

Participant milestones
Measure	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.	Cohort 2 (Participants From Cohort 1): Neosaldina All participants from Cohort 1 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 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.
Cohort 1 STARTED	216	0
Cohort 1 COMPLETED	215	0
Cohort 1 NOT COMPLETED	1	0
Cohort 2 STARTED	0	138
Cohort 2 COMPLETED	0	137
Cohort 2 NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Cohort 2 (Participants From Cohort 1): Neosaldina All participants from Cohort 1 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 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.
Cohort 1 Adverse Event	1	0
Cohort 2 Adverse Event	0	1

Baseline Characteristics

A Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-type Headaches (TTH) in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (All Participants): Neosaldina n=216 Participants 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.
Age, Continuous	38.56 years STANDARD_DEVIATION 11.97 • n=5 Participants
Sex: Female, Male Female	172 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	18 Participants n=5 Participants
Race/Ethnicity, Customized White	178 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment Brazil	216 Participants n=5 Participants
Occupation Employed	130 Participants n=5 Participants
Occupation Employed and student	52 Participants n=5 Participants
Occupation Homemaker	13 Participants n=5 Participants
Occupation Student	10 Participants n=5 Participants
Occupation Retired	8 Participants n=5 Participants
Occupation Unemployed	2 Participants n=5 Participants
Occupation Unknown	1 Participants n=5 Participants
Household Income 0.5 to 1 minimum wage	4 Participants n=5 Participants
Household Income 1 to 2 minimum wage	15 Participants n=5 Participants
Household Income 2 to 3 minimum wage	49 Participants n=5 Participants
Household Income 3 to 5 minimum wage	43 Participants n=5 Participants
Household Income 5 to 10 minimum wage	45 Participants n=5 Participants
Household Income 10 to 20 minimum wage	43 Participants n=5 Participants
Household Income 20 minimum wage	7 Participants n=5 Participants
Household Income Not reported	8 Participants n=5 Participants
Household Income No income	1 Participants n=5 Participants
Household Income Unknown	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 2 (Participants From Cohort 1): Neosaldina n=138 Participants All participants from Cohort 1 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 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.	Cohort 2 (Participants From Cohort 1): Neosaldina All participants from Cohort 1 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 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.
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 Interval -690.0 to 120.0	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 2 (Participants From Cohort 1): Neosaldina n=152 Participants All participants from Cohort 1 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 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.	Cohort 2 (Participants From Cohort 1): Neosaldina n=138 Participants All participants from Cohort 1 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 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.
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	45.65 percentage of participants
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	28.26 percentage of participants
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	10.87 percentage of participants
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	6.52 percentage of participants
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	5.07 percentage of participants
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	1.45 percentage of participants
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	2.17 percentage of participants

SECONDARY outcome

Timeframe: 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.

Pain intensity was measured by VAS which was an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (very intense pain).

Outcome measures

Outcome measures
Measure	Cohort 2 (Participants From Cohort 1): Neosaldina n=125 Participants All participants from Cohort 1 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 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.	Cohort 2 (Participants From Cohort 1): Neosaldina n=132 Participants All participants from Cohort 1 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 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.
Cohorts 1 and 2: Time to Achieve 50 Percent (%) of Pain Intensity Reduction	45.36 minutes Standard Deviation 26.63	51.36 minutes Standard Deviation 31.89

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 2 (Participants From Cohort 1): Neosaldina n=143 Participants All participants from Cohort 1 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 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.	Cohort 2 (Participants From Cohort 1): Neosaldina n=135 Participants All participants from Cohort 1 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 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.
Cohorts 1 and 2: Time to First Perceptible Pain Relief (PR)	30.31 minutes Standard Deviation 20.57	31.11 minutes Standard Deviation 22.34

SECONDARY outcome

Timeframe: 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.

Duration of PR was defined by the time of second intake of study medication.

Outcome measures

Outcome measures
Measure	Cohort 2 (Participants From Cohort 1): Neosaldina n=6 Participants All participants from Cohort 1 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 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.	Cohort 2 (Participants From Cohort 1): Neosaldina All participants from Cohort 1 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 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.
Cohort 1: Mean Duration of PR for Participants With Second Neosaldina Intake	5.16 hours Standard Deviation 2.26	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Cohort 2 (Participants From Cohort 1): Neosaldina n=216 Participants All participants from Cohort 1 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 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.	Cohort 2 (Participants From Cohort 1): Neosaldina n=138 Participants All participants from Cohort 1 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 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.
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction Very satisfied	91 Participants	63 Participants
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction Satisfied	99 Participants	59 Participants
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction Indifferent	6 Participants	5 Participants
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction Dissatisfied	7 Participants	3 Participants
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction Very dissatisfied	2 Participants	1 Participants
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Patient Global Assessments of Overall Satisfaction Unknown	11 Participants	7 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Cohort 2 (Participants From Cohort 1): Neosaldina n=216 Participants All participants from Cohort 1 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 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.	Cohort 2 (Participants From Cohort 1): Neosaldina n=138 Participants All participants from Cohort 1 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 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.
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction Very satisfied	94 Participants	62 Participants
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction Satisfied	98 Participants	62 Participants
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction Indifferent	8 Participants	3 Participants
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction Dissatisfied	3 Participants	3 Participants
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction Very dissatisfied	2 Participants	1 Participants
Cohorts 1 and 2: Number of Participants Categorized Based on Treatment Satisfaction According to Physician Global Assessments of Overall Satisfaction Unknown	11 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 2 (Participants From Cohort 1): Neosaldina n=216 Participants All participants from Cohort 1 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 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.	Cohort 2 (Participants From Cohort 1): Neosaldina All participants from Cohort 1 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 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.
Cohort 1: Number of Participants Who Experienced at Least One Adverse Event (AE) After Neosaldina Administration	6 Participants	—

Adverse Events

Cohort 1 (All Participants): Neosaldina

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 (All Participants): Neosaldina n=216 participants at risk 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.
Gastrointestinal disorders Nausea	0.46% 1/216 • Treatment-emergent adverse events are adverse events that started after Day 1 up to Day 45 AEs are reported for the safety analysis set which included all participants who were enrolled in Cohort 1 with at least one headache report in the mobile phone application during the study. Incidence of adverse events was calculated based on the number of adverse events experienced divided by the total number of participants
Nervous system disorders Sleepiness	0.93% 2/216 • Treatment-emergent adverse events are adverse events that started after Day 1 up to Day 45 AEs are reported for the safety analysis set which included all participants who were enrolled in Cohort 1 with at least one headache report in the mobile phone application during the study. Incidence of adverse events was calculated based on the number of adverse events experienced divided by the total number of participants
General disorders Lack of vitamin D	0.46% 1/216 • Treatment-emergent adverse events are adverse events that started after Day 1 up to Day 45 AEs are reported for the safety analysis set which included all participants who were enrolled in Cohort 1 with at least one headache report in the mobile phone application during the study. Incidence of adverse events was calculated based on the number of adverse events experienced divided by the total number of participants
Vascular disorders Hypertension	0.46% 1/216 • Treatment-emergent adverse events are adverse events that started after Day 1 up to Day 45 AEs are reported for the safety analysis set which included all participants who were enrolled in Cohort 1 with at least one headache report in the mobile phone application during the study. Incidence of adverse events was calculated based on the number of adverse events experienced divided by the total number of participants
Infections and infestations Bacterial infection	0.46% 1/216 • Treatment-emergent adverse events are adverse events that started after Day 1 up to Day 45 AEs are reported for the safety analysis set which included all participants who were enrolled in Cohort 1 with at least one headache report in the mobile phone application during the study. Incidence of adverse events was calculated based on the number of adverse events experienced divided by the total number of participants

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER