NCT03655184

Brief Summary

Medication overuse headache (MOH) is a disabling and costly disorder which is characterized by chronic headache and overuse of different headache medications. Patients with MOH are more likely to coexist with affective disorders such as anxiety and depression, and are more likely to suffer from sleep disturbances than those with episodic headache. Melatonin is a hormone secreted from the pineal gland. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic. This observational study aims to investigate clinical characteristics of patients with MOH and to explore the relationship between the serum melatonin level and medication overuse headache. Researchers hope to provide a new idea for the clinical treatment of MOH: melatonin can be used as an adjuvant therapy for MOH in the future.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

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 10, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

June 26, 2019

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

August 29, 2018

Last Update Submit

June 24, 2019

Conditions

Medication Overuse Headache

Keywords

melatoninmedication Overuse HeadachemigraineNeuropsychology

Outcome Measures

Primary Outcomes (1)

  • Serum melatonin level

    Blood samples taken for melatonin were centrifuged, and the serum content was separated and collected for analysis at -70 °C.

    30 minutes

Secondary Outcomes (3)

  • Hospital Anxiety and Depression Scale (HADS)

    15 minutes

  • Pittsburgh sleep quality index (PSQI)

    15 minutes

  • Leeds Dependence Questionnaire (LDQ)

    15 minutes

Study Arms (3)

MOH group

Patients with medication overuse headache

Episodic migraine group

Patients with episodic migraine

Healthy group

No headache or other special medical history

Eligibility Criteria

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

Outpatients and inpatients in the First Affiliated Hospital of Nanjing Medical University

You may qualify if:

  • Subject has medication overuse headache. Headache occurring on 15 or more days per month for more than 3 months. The number of medication days ≥10 days/month for triptans, ergotamine, opioids, combination analgesics, or multiple drug classes not individually overused; ≥15 days/ month for simple analgesic
  • Subject has had 1-8 migraines per month over the previous 3 months
  • Sign the informed consent

You may not qualify if:

  • Subjects combine with other pain syndromes and long-term oral analgesics are needed
  • History of bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

  • Tao H, Wan Q, Sun M, Cai K, Song Y, He M, Shen J. Involvement of Plasma Melatonin in Medication-Overuse Headache: A Cross-Sectional Study. Clin Neuropharmacol. 2024 Jan-Feb 01;47(1):12-16. doi: 10.1097/WNF.0000000000000573. Epub 2023 Oct 19.

    PMID: 37852214DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples were stored at -70 ℃

MeSH Terms

Conditions

Headache Disorders, SecondaryMigraine Disorders

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, Primary

Study Officials

  • Qi Wan, professor

    The First Affiliated Hospital with Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Qi Wan, professor

CONTACT

13770316989qi_wan@126.com

Huimin Tao, master

CONTACT

15720809858taohuiminsky@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

September 10, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

June 26, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)