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A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine

ConditionAcute Migraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKallyope Inc.

About this trial

This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins' in the base study and completed the 2-hour and 4-hour post-dose assessments in the eDiary.

Participant voluntarily agrees to participate in the study by giving written informed consent;

Participant is able to read, understand, and complete the study questionnaires and diary;

Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;

Disqualifiers

Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study);

Has, at the time of the base study EoS/Visit 3, had any change in medical history or a laboratory finding since screening in the acute treatment study that in the opinion of the investigator renders the participant unsuitable for this study (e.g., development of a finding that would have precluded participation in the base acute treatment study);

Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS) taken during the base study E0S/Visit 3, or of harm to others in the opinion of the investigator. Participants must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in 'since last version' version of the C-SSRS;

Participant is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during trial participation) as assessed for the base study E0S/Visit 3;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Elismetrep

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Elismetrep 10 mgExperimental treatment 2 interventions
Group B: Elismetrep 20 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with at least one treatment-emergent adverse event (TEAE)

Time frame
Through study completion, an average of 1 year
2

Proportion of participants with at least one treatment-emergent serious adverse event (SAE)

Time frame
Through study completion, an average of 1 year
3

Proportion of participants with TEAEs leading to study drug discontinuation

Time frame
Through study completion, an average of 1 year
4

Proportion of participants with TEAEs that occur in at least 5% of treated participants in either treatment arm

Time frame
Through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Kallyope Inc.

Lead sponsor

Source ClinicalTrials.gov
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