NCT03874832

Brief Summary

Single-center, single-dose, open-label, 2-part, 3-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
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2018

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

September 11, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

March 7, 2019

Last Update Submit

November 25, 2019

Conditions

Migraine With AuraMigraine Without AuraMigraine

Keywords

dihydroergotaminedihydroergotamine mesylatemigraine

Outcome Measures

Primary Outcomes (2)

  • STS101 Dose Selection - Part 1

    To select a dose level of STS101 for further evaluation in Part 2

    Pre-dose through 48 hours post-dose

  • DHE Relative Bioavailability - Part 2

    To assess the relative bioavailability of dihydroergotamine following a single dose of STS101 at the dose level selected in Part 1 compared to a single dose of 1 mg DHE administered by intramuscular injection and 2 mg DHE administered as nasal spray

    Pre-dose through 48 hours post-dose

Secondary Outcomes (4)

  • DHE Area Under the Curve [AUC] - Part 1

    Pre-dose through 48 hours post-dose

  • 8'OH-DHE Area Under the Curve [AUC] - Part 1

    Pre-dose through 48 hours post-dose

  • Serious Adverse Events - Parts 1 & 2

    Pre-dose through 48 hours post-dose

  • Treatment-Related Adverse Events - Parts 1 & 2

    Pre-dose through 48 hours post-dose

Study Arms (5)

STS101 1.5 mg

EXPERIMENTAL

STS101 (dihydroergotamine nasal powder), 1.5 mg

Drug: Dihydroergotamine

STS101 3.0 mg

EXPERIMENTAL

STS101 (dihydroergotamine nasal powder), 3.0 mg

Drug: Dihydroergotamine

STS101 6.0 mg

EXPERIMENTAL

STS101 (dihydroergotamine nasal powder), 6.0 mg

Drug: Dihydroergotamine

DHE intramuscular injection

ACTIVE COMPARATOR

Dihydroergotamine mesylate

Drug: Dihydroergotamine

DHE nasal spray

ACTIVE COMPARATOR

Dihydroergotamine mesylate

Drug: Dihydroergotamine

Interventions

DihydroergotamineDRUG

Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Also known as: Dihydroergotamine Mesylate
DHE intramuscular injectionDHE nasal spraySTS101 1.5 mgSTS101 3.0 mgSTS101 6.0 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)

  • Albrecht D, Iwashima M, Dillon D, Harris S, Levy J. A Phase 1, Randomized, Open-Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects. Headache. 2020 Apr;60(4):701-712. doi: 10.1111/head.13737. Epub 2020 Jan 27.

    PMID: 31985049DERIVED

MeSH Terms

Conditions

Migraine with AuraMigraine without AuraMigraine Disorders

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 A Levy, MD, PhD

    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 7, 2019

First Posted

March 14, 2019

Study Start

September 11, 2018

Primary Completion

November 7, 2018

Study Completion

November 7, 2018

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)