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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 (PRESTO)

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ClinicalTrials.gov Identifier: NCT02115269
Recruitment Status : Completed
First Posted : April 16, 2014
Results First Posted : September 25, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Almedis
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Conditions Headache Disorders, Primary
Migraine With Aura
Migraine Without Aura
Tension-Type Headache
Enrollment 759
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Primary Headaches
Hide Arm/Group Description Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Period Title: Overall Study
Started 759
Completed 702
Not Completed 57
Reason Not Completed
Lost to Follow-up             43
Did not complete patient diary             3
Moved to another city             7
Withdrawal by Subject             2
Didn't take study drug             2
Arm/Group Title Primary Headaches
Hide Arm/Group Description Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Overall Number of Baseline Participants 702
Hide Baseline Analysis Population Description
Safety set included all enrolled patients who have taken at least one dose of IndoProCaf
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 702 participants
39.6  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 702 participants
Female
542
  77.2%
Male
160
  22.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 702 participants
Ukraine
432
  61.5%
Kazakhstan
270
  38.5%
1.Primary Outcome
Title Percentage of Patients With Significant Pain Reduction
Hide Description 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
Time Frame up to 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Primary Headaches
Hide Arm/Group Description:
Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Overall Number of Participants Analyzed 663
Measure Type: Number
Unit of Measure: percentage of participants
90.3
2.Primary Outcome
Title Percentage of Patients Who Are Satisfied With IndoProCaf Treatment
Hide Description 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.
Time Frame up to 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Primary Headaches
Hide Arm/Group Description:
Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Overall Number of Participants Analyzed 663
Measure Type: Number
Unit of Measure: percentage of participants
91.3
3.Secondary Outcome
Title Time to Significant Pain Reduction
Hide Description 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
Time Frame up to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Significant Pain Reduction at 1 Hour Post Dose Significant Pain Reduction at 2 Hours Post Dose Significant Pain Reduction at 4 Hour Post Dose Significant Pain Reduction at 6 Hours Post Dose Significant Pain Reduction at 24 Hours Post Dose
Hide Arm/Group Description:
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 1 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 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 4 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
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
Overall Number of Participants Analyzed 663 663 663 663 663
Measure Type: Number
Unit of Measure: participants
464 252 176 50 15
4.Secondary Outcome
Title Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response
Hide Description 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
Time Frame up to 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who took second IndoProCaf dose at 2 hours post-dose
Arm/Group Title Primary Headaches
Hide Arm/Group Description:
Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Overall Number of Participants Analyzed 225
Measure Type: Number
Unit of Measure: percentage of participants
55.6
5.Secondary Outcome
Title Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse
Hide Description 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
Time Frame up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Primary Headaches
Hide Arm/Group Description:
Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: percentage of participants
90.0
6.Secondary Outcome
Title Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack
Hide Description Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Patients With Primary Headaches and Took Triptans in the Past Patients With Primary Headaches Who Took NSAIDs and Analgesics Patients Who Took Combined Analgesics Patients Who Took Ergotamine-based Drugs Patients Who Took Antiemetics Patients Who Took Opioid Analgesics
Hide Arm/Group Description:
Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice who took triptans in the past.
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 NSAIDs and 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 combined analgesics in the past
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 ergotamine-based drugs in the past
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 antiemetics in the past
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
Overall Number of Participants Analyzed 128 515 387 34 34 11
Measure Type: Number
Unit of Measure: percentage of participants
48.4 22.1 29.2 35.3 23.5 27.3
Time Frame [Not Specified]
Adverse Event Reporting Description

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.

 
Arm/Group Title Primary Headaches
Hide Arm/Group Description Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
All-Cause Mortality
Primary Headaches
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Primary Headaches
Affected / at Risk (%) # Events
Total   3/702 (0.43%)    
General disorders   
Face oedema  1  1/702 (0.14%)  1
Nervous system disorders   
Loss of consiousness  1  1/702 (0.14%)  1
Vascular disorders   
Hypertension crisis  1/702 (0.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Primary Headaches
Affected / at Risk (%) # Events
Total   16/702 (2.28%)    
Cardiac disorders   
Tachycardia   1/702 (0.14%)  1
Eye disorders   
Visual impairment   3/702 (0.43%)  3
Gastrointestinal disorders   
Nausea   4/702 (0.57%)  4
Abdominal pain upper   2/702 (0.28%)  2
Dyspepsia   2/702 (0.28%)  2
Vomiting   1/702 (0.14%)  1
General disorders   
Asthenia   1/702 (0.14%)  1
Gait disturbance   1/702 (0.14%)  1
Oedema Peripheral   1/702 (0.14%)  1
Investigations   
Blood pressure increased   2/702 (0.28%)  2
Musculoskeletal and connective tissue disorders   
Back pain   1/702 (0.14%)  1
Nervous system disorders   
Dizziness   5/702 (0.71%)  5
Hypoaesthesia   1/702 (0.14%)  1
Presyncope   1/702 (0.14%)  1
Tremor   1/702 (0.14%)  1
Psychiatric disorders   
Insomnia   1/702 (0.14%)  1
Irritability   1/702 (0.14%)  1
Skin and subcutaneous tissue disorders   
Pruritus   1/702 (0.14%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jean-Pascal Berrou, Global Medical Director CNS/Pain
Organization: Abbott
Phone: +41614870457
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02115269     History of Changes
Other Study ID Numbers: P14-389
First Submitted: April 9, 2014
First Posted: April 16, 2014
Results First Submitted: May 4, 2017
Results First Posted: September 25, 2017
Last Update Posted: November 6, 2017