Health TrialsbyHealthPanel

Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments

ConditionsMigraine DisordersChronic MigraineEpisodic Migraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation

About this trial

Primary working hypothesis is that NON-responders to mAbs bear a dysfunction of the endocannabidiome system (eCBome), as suggested by pre-clinical and clinical data by our group.

They will be identified as patients showing a reduction of monthly migraine days \< 50% after three months of treatment.

The clinical, biochemical and neurofunctional impact of novel therapeutic approaches expected to interfere with eCBome will be evaluated in NON-responder patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

male and female patients aged 18 to 75 years

diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria

for episodic migraine: 8-14 monthly migraine days in the previous 3 months

diagnosis of resistant migraine, defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months

Disqualifiers

history of major psychiatric or other neurological conditions

diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)

clinically significant medical conditions

chronic pain conditions

Trial population

Subjects with chronic and high frequency episodic migraine attending the outpatient clinic of the Headache Science \& Neurorehabilitation Unit of the IRCCS Mondino Foundation (Pavia, Italy) and the Neurology Department of the University of L'Aquila (Avezzano, Italy).

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Palmitoyl ethanolamide

    Dietary supplement

    PEA supplementation (600mg twice a day for three months)

  • Ketogenic diet

    Behavioral

    Diet characterized by the following percentages of macronutrients: 65% fat, 27% protein and 8% carbohydrates

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: NON-Responders2 interventions
Group B: Partial-Responders1 intervention

Trial outcomes

Primary outcomes

1

Monthly migraine days (MMDs)

MMDs during treatment with PEA or KD (continuous variable)

Time frame
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)

Secondary outcomes

1

Monthly headache days (MHDs)

MHDs during treatment with PEA or KD (continuous variable)

Time frame
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
2

Monthly days and doses of acute drug intake

Monthly days and doses of acute drug intake during treatment with PEA or KD (continuous variable)

Time frame
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
3

Percentage of patients with a 50% reduction in MMDs

Percentage of patients with a 50% reduction in MMDs during treatment with PEA or KD (continuous variable)

Time frame
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
4

Migraine related disability assessed by means of MIDAS

Migraine related disability assessed by means of MIDAS during treatment with PEA or KD (continuous variable)

Time frame
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS National Neurological Institute "C. Mondino" Foundation

Lead sponsor

University of L'Aquila

Collaborator

Source ClinicalTrials.gov
Apply now