Trial Outcomes & Findings for IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice (NCT NCT02115269)

Last Updated: 2017-11-06

Results Overview

significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest

Recruitment status

COMPLETED

Target enrollment

759 participants

Primary outcome timeframe

up to 2 hours

Results posted on

2017-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Primary Headaches Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Overall Study STARTED	759
Overall Study COMPLETED	702
Overall Study NOT COMPLETED	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Primary Headaches Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Overall Study Lost to Follow-up	43
Overall Study Did not complete patient diary	3
Overall Study Moved to another city	7
Overall Study Withdrawal by Subject	2
Overall Study Didn't take study drug	2

Baseline Characteristics

IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Headaches n=702 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Age, Continuous	39.6 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	542 Participants n=5 Participants
Sex: Female, Male Male	160 Participants n=5 Participants
Region of Enrollment Ukraine	432 Participants n=5 Participants
Region of Enrollment Kazakhstan	270 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 2 hours

Population: Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting.

Outcome measures

Outcome measures
Measure	Primary Headaches n=663 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice	Significant Pain Reduction at 2 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 2 hours post dose	Significant Pain Reduction at 4 Hour Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 4 hours post dose	Significant Pain Reduction at 6 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 6 hours post dose	Significant Pain Reduction at 24 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 24 hours post dose	Patients Who Took Opioid Analgesics Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took opioid analgesics in the past
Percentage of Patients With Significant Pain Reduction	90.3 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 24 hours post dose

Patients are asked to evaluate their satisfaction with headache pain reduction after treatment by selecting the options: =very poor, =poor, =no opinion, =good, =very good. The satisfied patients are defined as those with =good and = very good answers.

Outcome measures

Outcome measures
Measure	Primary Headaches n=663 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice	Significant Pain Reduction at 2 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 2 hours post dose	Significant Pain Reduction at 4 Hour Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 4 hours post dose	Significant Pain Reduction at 6 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 6 hours post dose	Significant Pain Reduction at 24 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 24 hours post dose	Patients Who Took Opioid Analgesics Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took opioid analgesics in the past
Percentage of Patients Who Are Satisfied With IndoProCaf Treatment	91.3 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 24 hours post-dose

Time to significant pain reduction at 1, 2, 4, 6 and 24 hours post-dose period are summarized with number of patients in each category; significant pain reduction is defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest

Outcome measures

Outcome measures
Measure	Primary Headaches n=663 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice	Significant Pain Reduction at 2 Hours Post Dose n=663 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 2 hours post dose	Significant Pain Reduction at 4 Hour Post Dose n=663 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 4 hours post dose	Significant Pain Reduction at 6 Hours Post Dose n=663 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 6 hours post dose	Significant Pain Reduction at 24 Hours Post Dose n=663 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 24 hours post dose	Patients Who Took Opioid Analgesics Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took opioid analgesics in the past
Time to Significant Pain Reduction	464 participants	252 participants	176 participants	50 participants	15 participants	—

SECONDARY outcome

Timeframe: up to 2 hours

Population: Patients who took second IndoProCaf dose at 2 hours post-dose

Outcome measures

Outcome measures
Measure	Primary Headaches n=225 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice	Significant Pain Reduction at 2 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 2 hours post dose	Significant Pain Reduction at 4 Hour Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 4 hours post dose	Significant Pain Reduction at 6 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 6 hours post dose	Significant Pain Reduction at 24 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 24 hours post dose	Patients Who Took Opioid Analgesics Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took opioid analgesics in the past
Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response	55.6 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 48 hours

Population: Patients who had headache relapse. Headache relapse was defined as a worsening of headache attack after 24 hours of the initial dosing and pain-free at 2h but no later than 48 hours of initial IndoProCaf dosing.

Outcome measures

Outcome measures
Measure	Primary Headaches n=80 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice	Significant Pain Reduction at 2 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 2 hours post dose	Significant Pain Reduction at 4 Hour Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 4 hours post dose	Significant Pain Reduction at 6 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 6 hours post dose	Significant Pain Reduction at 24 Hours Post Dose Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 24 hours post dose	Patients Who Took Opioid Analgesics Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took opioid analgesics in the past
Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse	90.0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline

Population: Patients who took trip tans in the past (data are from Safety set which included all enrolled patients who have taken at least one dose of IndoProCaf).

Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)

Outcome measures

Outcome measures
Measure	Primary Headaches n=128 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice	Significant Pain Reduction at 2 Hours Post Dose n=515 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 2 hours post dose	Significant Pain Reduction at 4 Hour Post Dose n=387 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 4 hours post dose	Significant Pain Reduction at 6 Hours Post Dose n=34 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 6 hours post dose	Significant Pain Reduction at 24 Hours Post Dose n=34 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 24 hours post dose	Patients Who Took Opioid Analgesics n=11 Participants Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took opioid analgesics in the past
Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack	48.4 percentage of participants	22.1 percentage of participants	29.2 percentage of participants	35.3 percentage of participants	23.5 percentage of participants	27.3 percentage of participants

Adverse Events

Primary Headaches

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Primary Headaches n=702 participants at risk Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Vascular disorders Hypertension crisis	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
General disorders Face oedema	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Nervous system disorders Loss of consiousness	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.

Other adverse events

Other adverse events
Measure	Primary Headaches n=702 participants at risk Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Gastrointestinal disorders Nausea	0.57% 4/702 • Number of events 4 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Gastrointestinal disorders Abdominal pain upper	0.28% 2/702 • Number of events 2 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Gastrointestinal disorders Dyspepsia	0.28% 2/702 • Number of events 2 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Gastrointestinal disorders Vomiting	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Nervous system disorders Dizziness	0.71% 5/702 • Number of events 5 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Nervous system disorders Hypoaesthesia	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Nervous system disorders Presyncope	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Nervous system disorders Tremor	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Eye disorders Visual impairment	0.43% 3/702 • Number of events 3 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
General disorders Asthenia	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
General disorders Gait disturbance	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
General disorders Oedema Peripheral	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Investigations Blood pressure increased	0.28% 2/702 • Number of events 2 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Psychiatric disorders Insomnia	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Psychiatric disorders Irritability	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Cardiac disorders Tachycardia	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Musculoskeletal and connective tissue disorders Back pain	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
Skin and subcutaneous tissue disorders Pruritus	0.14% 1/702 • Number of events 1 Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold. The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.

Additional Information

Jean-Pascal Berrou, Global Medical Director CNS/Pain

Abbott

Phone: +41614870457

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60