Recruiting

Low-dose Naltrexone

Sponsor:

Thomas Jefferson University

Code:

NCT05536050

Conditions

Chronic Migraine

Fibromyalgia

New Daily Persistent Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Migraine diary and Questionnaires

Study Details

Brief summary:

This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. A few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. Our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.

Conditions

Chronic Migraine

Fibromyalgia

New Daily Persistent Headache

Study ID

NCT05536050

Start date

Jul 28, 2022

Status verified date

Oct, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Subjects will be adults of all genders ages 18 and older.
  • Patients with a diagnosis of CM (with or without NDPH) by IHC-3 criteria, diagnosed by a certified headache specialist.
  • Subjects who received a new prescription for LDN
  • Fibromyalgia-diagnosed according to Fibromyalgia Rapid Screening Tool
  • Subjects should be on stable headache and migraine preventives for the past 2 months with no plans to change medication for the next 4 months.
  • Subjects willing to maintain a headache/migraine diary one month prior to taking medication and while taking the medication, either physical or electronic diary of their choice.
  • Subjects willing to fill out pre and post intervention surveys
  • Subjects willing to comply with planned follow up phone calls and visits.

Exclusion Criteria:

  • Not planning on follow up care with clinician.
  • Patients with decreased decision-making capacity in which the investigator's opinion would interfere with the person's ability to provide informed consent and complete study questionnaires.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Interventions

Migraine diary and Questionnaires

Patients who already have a prescription for low-dose naltrexone will be administered questionnaires twice during the trial. Additionally, patients will maintain migraine diary for the duration of the trial.

Primary outcome measure

  • Effectiveness on migraine [ Time Frame: 9-12 weeks ]

Central Contacts and Locations

Locations

Jefferson Headache Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Michael Marmura, MD

215-955-2243michael.marmura@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Oct 27, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2022-10-27.