Health TrialsbyHealthPanel

Amylin-Induced Migraine Attacks Without Aura

ConditionsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesNervous System DiseasesCentral Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMigraine DisordersHeadachePainPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAmylinPramlintide
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDanish Headache Center

About this trial

Pramlintide is a peptide analogue of human amylin which is a vasoactive signaling molecule involved in the pathogenesis of migraine. This study investigates whether pramlintide induces migraine attacks without aura in people with migraine without aura.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 65 years of age upon entry into screening

A body weight of 50 to 100 kg

History of migraine without aura for ≥12 months and in accordance with ICHD-3

Between 1-5 monthly migraine days without aura on average across the 3 months prior to screening

Disqualifiers

Any history of a primary or secondary headache disorder other than migraine without aura and infrequent episodic tension-type headache

Any history of moderate to severe traumatic brain injury

Any history of cardiovascular disease, including cerebrovascular diseases

Any history of pulmonary disease

Trial design

Design model

Crossover

Treatments tested in this trial

  • Amylin

    Drug

    The participants will receive continuous intravenous infusion of 20 mL (6 μg/min) of pramlintide (amylin) over 20 minutes.

  • Placebo

    Drug

    The participants will receive continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: AmylinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of migraine attacks without aura

The difference in the incidence of migraine attacks without aura between pramlintide and placebo during the 12-hour observational period after infusion start.

Time frame
12 hours

Secondary outcomes

1

Headache intensity scores

The secondary outcome is the difference in the area under the curve (AUC) for median headache intensity scores between pramlintide and placebo during the 12-hour observational period after infusion start.

Time frame
12 hours

Other outcomes

1

Superficial temporal artery dilation

The difference in AUC for relative superficial temporal artery (STA) dilation between pramlintide and placebo from the start of infusion to 2 hours after the infusion.

Time frame
2 hours
2

Middle cerebral artery blood flow velocity

The difference in AUC for change in middle cerebral artery (MCA) mean blood flow velocity between pramlintide and placebo from the start of infusion to 2 hours after the infusion.

Time frame
2 hours

Sponsors and contacts

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

Danish Headache Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: