Health TrialsbyHealthPanel

Cannabis for the Prophylactic Treatment of Migraine

ConditionChronic Migraine
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Calgary

About this trial

This study will evaluate the efficacy and safety of cannabis for the treatment of chronic migraine headaches. Study subjects will be randomized to one of three groups: lower dose CBD, higher dose CBD or placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is willing and able to give signed informed consent.

Male and female patients aged 25 years or older.

History of migraine for at least 12 months as diagnosed by the International Classification of Headache Disorders (ICHD-3).

Chronic migraine for at least the previous 3 months prior to screening, as diagnosed by ICHD-3.

Disqualifiers

Other active primary headaches, such as cluster headache, hemicrania continua, etc.

Any secondary headache, such as headache related to intracranial hypertension, intracranial hypotension, hydrocephalus, intracranial mass lesion, etc.

Pregnant, planning to become pregnant, or breastfeeding.

Active or significant history of major mental illness, including severe depression, or anxiety, and any history of psychosis or schizophrenia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CBD 100 mg OD

    Drug

    CBD oil - purified to \<1% THC in soft-gel capsules

  • CBD 200 mg OD

    Drug

    CBD oil - purified to \<1% THC in soft-gel capsules

  • Placebo

    Drug

    Soft-gel capsules containing placebo

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: CBD 100 mg ODActive comparator 1 intervention
Group B: CBD 200 mg ODExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The mean change in the number of headache days between the 4-week baseline period compared to the 4-week period just preceding the 3 month follow-up visit.

Time frame
Baseline and weeks 9-12

Secondary outcomes

1

The mean change in the number of headache days between baseline compared to the 4-week period just preceding the 6 month follow-up visit.

Time frame
Weeks -4 to 0 and weeks 21-24
2

The percentage of patients who have at least a 50% reduction in their headache frequency between baseline compared to weeks 9-12 (the 50% responder rate).

Time frame
Weeks -4 to 0 and weeks 9-12
3

The change in the mean headache intensity between baseline compared to weeks 9-12, and weeks 21-24.

Time frame
Weeks -4 to 0, weeks 9-12 and weeks 21-24
4

The mean change in the number of days with acute pain medication use between baseline compared to weeks 9-12, and 21-24.

Time frame
Weeks -4 to 0, weeks 9-12 and weeks 21-24

Other outcomes

Sponsors and contacts

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

University of Calgary

Lead sponsor

Source ClinicalTrials.gov
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