NCT05337254

Brief Summary

Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 29, 2022

Last Update Submit

April 13, 2022

Conditions

MigraineMigraine With AuraMigraine Without Aura

Keywords

dihydroergotaminedihydroergotamine mesylatemigraine

Outcome Measures

Primary Outcomes (2)

  • DHE Relative Bioavailability

    The relative bioavailability of STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of dose-corrected Cmax.

    Pre-dose through 48 hours Post-Dose

  • DHE Comparative Bioavailability

    The comparative bioavailability STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of Cmax .

    Pre-dose through 48 hours Post-Dose

Secondary Outcomes (2)

  • Serious Adverse Events

    Pre-dose through 48 hours Post-Dose

  • Treatment-Related Adverse Events

    Pre-dose through 48 hours Post-Dose

Study Arms (5)

STS101 5.2 mg

EXPERIMENTAL

STS101 (dihydroergotamine nasal powder), 5.2 mg

Drug: Dihydroergotamine

STS101 7.0 mg

EXPERIMENTAL

STS101 (dihydroergotamine nasal powder), 7.0 mg

Drug: Dihydroergotamine

STS101 8.6 mg

EXPERIMENTAL

STS101 (dihydroergotamine nasal powder), 8.6 mg

Drug: Dihydroergotamine

DHE intramuscular injection

ACTIVE COMPARATOR

Dihydroergotamine mesylate

Drug: Dihydroergotamine

DHE nasal spray

ACTIVE COMPARATOR

Dihydroergotamine mesylate

Drug: Dihydroergotamine

Interventions

DihydroergotamineDRUG

Dihydroergotamine intranasal powder

Also known as: Dihydroergotamine Mesylate
STS101 5.2 mgSTS101 7.0 mgSTS101 8.6 mg

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 50 years of age at the time of enrollment.
  • Signed the informed consent document.
  • Subject judged to be healthy by a qualified physician

You may not qualify if:

  • Abnormal physical findings of clinical significance at the screening examination
  • Significant abnormal laboratory values at the Screening Visit.
  • Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Sciences Miami Inc.

Miami, Florida, 33126, United States

Location

Related Publications (1)

  • Lipton RB, Albrecht D, Bermudez M, Hu J, Hussey E, Levy J. A randomized, open-label, 5-period crossover study evaluating the pharmacokinetics and safety of a single dose of intranasal dihydroergotamine (DHE) powder (STS101), intramuscular DHE mesylate, and liquid nasal spray DHE in healthy adults. Headache. 2024 Mar;64(3):266-275. doi: 10.1111/head.14685. Epub 2024 Feb 27.

    PMID: 38413540DERIVED

MeSH Terms

Conditions

Migraine DisordersMigraine with AuraMigraine without Aura

Interventions

Dihydroergotamine

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ErgotaminesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jeffrey Levy, MD

    Quotient Sciences Miami Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 20, 2022

Study Start

March 5, 2021

Primary Completion

June 4, 2021

Study Completion

June 4, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)