Acetaminophen and Ibuprofen With and Without Magnesium and Primary Migraine in Childhood

NCT01756209 | Completed Phase 4 Results DMC

• 1 other identifier: Migraine2010
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: The purpose of this study was to evaluate both the effects of ibuprofen and/or acetaminophen for the acute treatment of primary migraine in children in or out prophylactic treatment with magnesium. Methods: The study had been approved by the Researchers Ethics Committee of the "Pugliese-Ciaccio" Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36) and the children ranging from the ages of 5 to 18 years with at least four attack/month of primary migraine were enrolled. A Visual Analogical Scale was used to evaluate pain intensity at the moment of admission to the study (start of the study) and every month up to 18 months later (end of the study).

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Pain-relief

  The primary endpoint was when pain-relief took place and pain intensity differences from baseline (0 hour) to 3 hours after drug treatment. This measurement was defined as the AUC for the sum of the 2 measurements (pain relief and pain intensity difference) at each time point from 0 to 3 hours. Pain was measured using the vas analogue scale (range 0-10, where 0 = no pain (score 0) and 100 mm = worst pain (score 10)

  3 and 18 months

Study Arms (4)

Acetaminophen

ACTIVE COMPARATOR

Acetaminophen 15 mg/kg oral single dose (n=40)

Drug: acetaminophen 15 mg/kg

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 10 mg/kg oral single dose (n=40)

Drug: Ibuprofen 10 mg/kg

Acetaminophen + magnesium 400 mg

EXPERIMENTAL

Acetaminophen 15 mg/kg oral single dose (n=40) + magnesium 400 mg

Drug: Magnesium 400Mg; Drug: acetaminophen 15 mg/kg

ibuprofen + magnesium 400 mg

EXPERIMENTAL

ibuprofen 10 mg/kg oral single dose (n=40) + magnesium 400 mg

Drug: Magnesium 400Mg; Drug: Ibuprofen 10 mg/kg

Interventions

Magnesium 400Mg DRUG

magnesium 400 mg + conventional treatment

Also known as: magnesium

Acetaminophen + magnesium 400 mg; ibuprofen + magnesium 400 mg

Ibuprofen 10 mg/kg DRUG

ibuprofen 10 mg/kg oral single dose

Also known as: ibuprofen

Ibuprofen; ibuprofen + magnesium 400 mg

acetaminophen 15 mg/kg DRUG

Acetaminophen 15 mg/kg oral single dose

Also known as: acetaminophen

Acetaminophen; Acetaminophen + magnesium 400 mg

Eligibility Criteria

• Age: 5 Years - 18 Years
• Gender Eligibility Details: In each group, children were assigned in accordance to age and gender in order to obtain similar groups of treatment.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with migraine without aura (MoA) diagnosed according to the criteria for pediatric age of the International Classification of Headache Disorders (IHS-2)
• aged from 5 to 18 years
• at least four attacks /month

You may not qualify if:

• mental retardation (IQ \<70)
• genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome)
• hypothyroidism
• psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD),
• neuromuscular disorders,
• epilepsy,
• obesity (BMI\>95 percentiles),
• liver or renal diseases,
• gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn;
• hypersensitivity to medication studies.

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

Pugliese Ciaccio Hospital

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Magnesium; Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr Francesco Peltrone, Responsible of clinical trial
• Organization: Pugliese Hospital of Catanzaro

gallelli@unicz.it

+.39 0961 7123222

Study Officials

• Francesco Peltrone, MD

  Pugliese Ciaccio Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 25, 2012
• Study Start: January 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 25, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)