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A Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous TRV250

NCT04201080 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-09-22

No results posted yet for this study

Summary

A trial to assess the efficacy, safety, tolerability and effect of a drug (code name TRV250) given as an injection to subjects who have received an injection of a drug called glyceryl trinitrate (GTN) which is clinically known to induce an immediate headache of short duration (under 30 minutes), known as the "GTN immediate headache"

Conditions

  • Migraines

Interventions

DRUG

Part A: TRV250-20mg/ml

TRV250 SC Injections

DRUG

Placebo

Placebo SC injections

DRUG

Part B: TRV250 Dose 1

Dose 1of3 TRV250

DRUG

Part B: TRV250 Dose 2

Dose 2of3 TRV250 SC injections

DRUG

Part B: TRV250 Dose 3

Dose 3of3 TRV250 SC injections

DRUG

Placebo

Placebo SC injections

Sponsors & Collaborators

  • Trevena Inc.

    lead INDUSTRY

Principal Investigators

  • Dasyam, MBBS, Msc · MAC Clinical Research Manchester (Early Phase Unit)

  • Nicklas, RN BSN CCRC · Trevena Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-11
Primary Completion
2020-02-17
Completion
2020-08-10

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04201080 on ClinicalTrials.gov