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Naltrexone + Pyridostigmine for Chronic Fatigue Syndrome (LIFT Trial)

Boston, MA

Phase 2

Recruiting

Led By David Systrom, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is ≥ 18 and ≤ 65 years of age at screening, inclusive.

Participant has a body mass index (BMI) range of 17 to 40 kg/m2, inclusive.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 weeks

Summary

This trial will be held at Brigham and Women's Hospital (BWH) of Harvard Medical School and will focus on studying the effects of Pyridostigmine (Mestinon) and Low

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Who is the study for?

The LIFT trial is for adults aged 18-65 with ME/CFS who meet specific criteria, including orthostatic intolerance. Participants must not be women of childbearing potential or agree to contraception, have a BMI between 17 and 40, and commit to the study without joining another trial. They need a smartphone for an app used in the study.Check my eligibility

What is being tested?

This study at Brigham and Women's Hospital tests Pyridostigmine (30mg-60mg) and Low-Dose Naltrexone (1.5mg-4.5mg) on ME/CFS patients with Orthostatic Intolerance. It's double-blind with four groups: both drugs, each drug alone with placebo, or double placebo.See study design

What are the potential side effects?

Possible side effects include digestive issues from Pyridostigmine like cramps or diarrhea, sleep disturbances or vivid dreams from LDN, as well as headaches or fatigue from either medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My BMI is between 17 and 40.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional Capacity

Physiologic Response - Heart Rate Recovery (HRR)

Physiologic Response - Oxygen Uptake Efficiency Slope (OUES)

+1 more

Secondary study objectives

Blood Oxygen

DANA Brain Vital-Memory Search (MS)

DANA Brain Vital-Procedural Reaction Time (PRT)

+6 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Pyridostigmine/PlaceboActive Control2 Interventions

Pyridostigmine will be taken as liquid suspension three times a day, scaling up from 20mg (1.67mL) to 60mg (5mL) (180mg/day). Placebo will be taken as liquid suspension once a day, scaling up from 1.5mL to 4.5mL.

Group II: Placebo/LDNActive Control2 Interventions

Placebo will be taken as liquid suspension three times a day, scaling up from 1.67mL to 5mL. Low dose naltrexone will be taken as liquid suspension once a day, scaling up from 1.5mL to 4.5mL (4.5mg/day).

Group III: Pyridostigmine/LDNActive Control2 Interventions

Pyridostigmine will be taken as liquid suspension three times a day, scaling up from 20mg (1.67mL) to 60mg (5mL) (180mg/day). Low dose naltrexone will be taken as liquid suspension once a day, scaling up from 1.5mL to 4.5mL (4.5mg/day).

Group IV: Placebo/PlaceboPlacebo Group1 Intervention

Placebo will be taken as liquid suspension three times a day, scaling up from 1.67mL to 5mL. Placebo will be taken as liquid suspension once a day, scaling up from 1.5mL to 4.5mL .

0 / 2Eligibility criteria met