NCT04585698

Brief Summary

The aim of this study is to compare central and peripheric sensitization in headache patients at Baseline (T0) and 1 month after (T1) a treatment with an anti-CGRP (Fremanezumab-Ajovy).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 14, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 29, 2020

Last Update Submit

October 12, 2020

Conditions

Head Pain

Keywords

headachefremanezumabblink reflexnociceptive flexion reflexquantitative sensory testing

Outcome Measures

Primary Outcomes (2)

  • modulation of pain threshold by fremanezumab

    quantitative analysis of pain-related reflexes with QST (quantitative sensory testing) using Medoc Pathway

    one year

  • modulation of pain threshold by fremanezumab

    Blink reflex and nociceptive flexion reflex usig EMG Viking Viasys.

    one year

Study Arms (2)

headache patients

healthy subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with headache before and 1 month after receiving fremanezumab Age: 18-65 years Sex: 2/3 female, 1/3 male

You may not qualify if:

  • medication changes 1 month prior to the test
  • neuropathy
  • acute or chronic pain
  • medications having effects on the central nervous system
  • other disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in Medical Sciences

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 14, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

October 14, 2020

Record last verified: 2020-09