A Proof-of-Principle Study to Evaluate a Combination Therapyfor the Treatment of Migraine

• Conditions: Migraine

• Registration Number: EUCTR2004-002605-77-GB
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-23
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1)Age
Aged 18 and over.

2)Contraception
Females of childbearing potential must be established on a method of contraception, which in the Investigator’s opinion is acceptable, for at least 3 months prior to the start of the study.

3)Health
a)Diagnosed with migraine (with or without aura) according to the criteria established by International Headache Society 2004(3) and as assessed using the Migraine Diagnostic Questionnaire (see Protocol Section 7.1.3). This must include -
•Frequency of migraine attacks between 1-4 times per month for the past 3 months.
•Migraine attacks present for more than 1 year.
•Age at onset of migraine less than 50 years.
•Attacks of moderate intensity if untreated.
•Current use of an OTC analgesic medication for migraine gives some degree of pain relief.
b)Otherwise in good general physical health with, in the opinion of the Investigator, no other clinically significant and relevant abnormalities of medical history or physical examination.

4)Compliance
Understands and is willing, able and likely to comply with all study procedures and restrictions.

5)Consent
Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Disease
a)Patients who usually experience vomiting during the early stages (first 4 hours) of migraine attacks or when taking medication for the migraine attack.
b)Patients who have a diagnosis of both migraine headache and headache of a different aetiology where the patient cannot reliably distinguish between the different types of headache at onset.
c)In the opinion of the Investigator, significant head/neck injury or change in headache pattern during the previous 6 months.
d)Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder (except migraine) that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
e)Patients who have contra-indications to paracetamol; severe renal or severe hepatic impairment.
f)Patients who have contra-indications to domperidone; current or recent history of prolactin-releasing pituitary tumour; current or recent history of gastro intestinal haemorrhage, mechanical obstruction or perforation.
g)Patients who have contra-indications to ibuprofen; current or recent history of gastro-intestinal ulcer; asthma; history of bronchospasm, rhinitis or urticaria associated with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs).

2)Pregnancy
Female patients who are pregnant or who have a positive urine pregnancy test.

3)Breast-feeding
Female patients who are breast–feeding infants.

4)Allergy/Intolerance
Known or suspected intolerance or hypersensitivity to the study materials including rescue medication (or closely related compounds) or any of their stated ingredients.

5)Medications
a)Current daily use of any prescription or OTC (including herbal medication and health supplements; please refer to protocol Appendix 1 for examples) medicine (except an OTC medication for acute treatment of headache including migraine or contraception/HRT in women.)
b)Current use of prescription medication for migraine.
c)Current use of antipsychotic, antidepressant or antiepileptic medications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Total pain relief from dosing to the 1 hour assessment time point (TOTPAR0-1 hour)<br><br>;Main Objective: To compare total pain relief (TOTPAR) 0-1 hour for the combination treatments versus paracetamol.;Secondary Objective: Other comparisons of pain relief, pain intensity and other symptoms of migraine at time points up to 24 hours will be made between the three treatments. A comparison of adverse events (AEs) will also be made.