Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation

Migraine Clinical Trial

Official title:

Prediction of Migraine Prevention Efficacy: Individualization of Treatment by Coupling Drug's Mode of Action With Patient's Mechanism of Pain Modulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101892
• Other study ID #: 0102-14
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: October 1, 2017
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2017
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A major reason for the substantial underuse of pharmacological prevention of migraine is its inadequate efficacy, since only ~50% of patients respond to a specific agent. There is currently no evidence-based way to identify the patients that will respond to a specific preventive treatment. Amitriptyline is one of the commonest agents used for migraine prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of analgesics according to pain inhibitory capacity has been shown effective by our group for painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition capacity gained more from a drug that augment pain inhibition as compared to those with efficient inhibitory capacity. The investigators now propose to assess migraineurs for their pain inhibition capacity, and examine whether, along similar reasoning, those with reduced inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs, who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized two arms parallel double blind design, and followed up for attacks reduction. The investigators expect to identify the best predictors for efficacy of migraine prevention by the study drug. This approach will promote individualization of migraine therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age >18

• premenopausal

• meeting the international headache society criteria for migraine

• having >4 attacks or days of migraine/month

Exclusion Criteria:

• baseline month diary indicating lower frequency of migraine

• chronic migraine (>15 days of headache per month)

• use of migraine preventive treatment during previous 3 month

• language barrier or cognitive dysfunction

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Preventive Treatment

Intervention

Drug:
• Amitriptyline
per os, daily, evening
• placebo
per os, daily, evening

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Migraine Research Foundation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment	ANCOVA will be utilized, based on factors treatment (amitriptyline or placebo), conditioned pain modulation capabilities (responder or non-responder), their interaction, a number of covariates, to predict reduction attacks.	one year
Secondary	predictive value of pain-related psychological parameters for benefit from amitriptyline treatment	The scores for Spielberger's anxiety state and trait questionnaire, and for pain catastrophising questionnaire will be used.	one year