Clinical Trial Results:
An Open-Label Single-Dose Study to Evaluate the Pediatric Palatability of Maxalt Oral Disintegrating Tablets
Summary
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EudraCT number |
2011-002349-36 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
28 Feb 2011
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Results information
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Results version number |
v2(current) |
This version publication date |
16 Mar 2016
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First version publication date |
11 Mar 2015
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Other versions |
v1 |
Version creation reason |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
0462-107
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000084-PIP02-10 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Feb 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Feb 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Feb 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to evaluate the palatability of rizatriptan benzoate orally disintegrating tablets (Maxalt-MLT™ ODT) in healthy young male and female subjects, 6 to less than 12 years of age, with a history of migraines , who were not experiencing a migraine on the day of the assessment.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Feb 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
12
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
Screening occurred within 3 weeks prior to randomisation. Participants were 6 to less than 12 years of age with a history of migraines for at least 6 months but free of migraine on the day of study drug administration, weighed at least 20 kg, and were in good health at the time of screening. | ||||||
Period 1
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Period 1 title |
Single Dose Rizatriptan ODT (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Rizatriptan benzoate ODT | ||||||
Arm description |
Subjects were administered a single dose of either 5-mg or 10-mg rizatriptan benzoate ODT in open label fashion with the specific dose determined by the subject’s weight at predose on Day 1. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Rizatriptan Benzoate ODT
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Investigational medicinal product code |
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Other name |
Maxalt-MLT™ ODT
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Pharmaceutical forms |
Oral lyophilisate
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Routes of administration |
Oral use
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Dosage and administration details |
Participants weighing 20-39.9 kg received a 5 mg dose of rizatriptan benzoate (Maxalt-MLT™ ODT) in an open-label fashion and those weighing 40 kg and above received a 10 mg dose of rizatriptan benzoate (Maxalt-MLT™ ODT) in an open-label fashion with the specific dose determined by the participant's weight at predose on Day 1. Participants were to fast from all food and drink except water for 1 hour prior to dose administration. To clear the palate and wet the oral mucosa, 120 mL of water was administered 5 minutes prior to dose administration. Subsequently, the investigator (or representative) provided each participant with the study drug tablet at weight-based dose with verbal instructions to close their mouth and not swallow the tablet allowing it to dissolve on their tongue. When they felt it had disappeared from their tongue, they were then permitted to swallow it.
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Baseline characteristics reporting groups
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Reporting group title |
Rizatriptan benzoate ODT
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Reporting group description |
Subjects were administered a single dose of either 5-mg or 10-mg rizatriptan benzoate ODT in open label fashion with the specific dose determined by the subject’s weight at predose on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Rizatriptan benzoate ODT
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Reporting group description |
Subjects were administered a single dose of either 5-mg or 10-mg rizatriptan benzoate ODT in open label fashion with the specific dose determined by the subject’s weight at predose on Day 1. | ||
Subject analysis set title |
Rizatriptan benzoate ODT 10 mg
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants who received rizatriptan benzoate ODT 10 mg.
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Subject analysis set title |
Rizatriptan benzoate ODT 5 mg
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants who received rizatriptan benzoate ODT 5 mg.
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End point title |
Rizatriptan Palatability (Overall) [1] | ||||||||||||||||
End point description |
A palatability taste test assessment was performed in the immediate moments (5 minutes) after challenge with the rizatriptan benzoate ODT. Five minutes after dose administration, the subjects were queried for taste with a specific, standardized question and the participant's response was recorded with a validated 5-point facial hedonic scale with matching descriptive labels (Very Bad=1; Bad=2; Average=3; Good=4; Very Good=5).
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End point type |
Primary
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End point timeframe |
At 5 minutes after oral challenge with rizatriptan (Maxalt-MLT™ ODT) 5 mg and 10 mg.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Per protocol only summary statistics for palatability scores based on the 5 point hedonic scale were to be provided. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse experiences (AEs) were collected from the time of screening until approximately 14 days after study drug administration.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.1
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Reporting groups
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Reporting group title |
Rizatriptan benzoate ODT 5 mg
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Reporting group description |
Subjects were administered a single dose of 5-mg rizatriptan benzoate ODT in open label fashion on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Rizatriptan benzoate ODT 10 mg
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Reporting group description |
Subjects were administered a single dose of 10-mg rizatriptan benzoate ODT in open label fashion on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |