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Study protocol ... phase III trial ... of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study), 2022, Younger, Luciano et al

Discussion in ''Conditions related to ME/CFS' news and research' started by Andy, Jan 8, 2022.

  1. Andy

    Andy Committee Member

    Hampshire, UK
    Full title: Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost-utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study).



    There is evidence that low-dose naltrexone (LDN; <5.0 mg/day) reduces pain and improves the quality of life of people with fibromyalgia syndrome (FMS). However, no randomised controlled trials with long-term follow-ups have been carried out. The INNOVA study will evaluate the add-on efficacy, safety, cost–utility and neurobiological effects of LDN for reducing pain in patients with FMS, with a 1-year follow-up.

    Methods and analysis

    A single-site, prospective, randomised, double-blinded, placebo-controlled, parallel design phase III trial will be performed. Eligibility criteria include being adult, having a diagnosis of FMS and experiencing pain of 4 or higher on a 10-point numerical rating scale. Participants will be randomised to a LDN intervention group (4.5 mg/day) or to a placebo control group. Clinical assessments will be performed at baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3). The primary endpoint will be pain intensity. A sample size of 60 patients per study arm (120 in total), as calculated prior to recruitment for sufficient power, will be monitored between January 2022 and August 2024. Assessment will also include daily ecological momentary evaluations of FMS-related symptoms (eg, pain intensity, fatigue and sleep disturbance), and side effects via ecological momentary assessment through the Pain Monitor app during the first 3 months. Costs and quality-adjusted life years will be also calculated. Half of the participants in each arm will be scanned with MRI at T0 and T1 for changes in brain metabolites related to neuroinflammation and central sensitisation. Inflammatory biomarkers in serum will also be measured.

    Ethics and dissemination

    This study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and community engagement activities.

    Open access, https://bmjopen.bmj.com/content/12/1/e055351
  2. rvallee

    rvallee Senior Member (Voting Rights)

    Wut? WTH are "brain metabolites related to central sensitisation"? Literally not a thing. Ugh.
    Hutan and Lilas like this.
  3. shak8

    shak8 Senior Member (Voting Rights)

    It's been several years since the pilot study of LDN for FM by Younger. I'm glad they got funding to scale this up, even though the results of the pilot study (if pilot is the term) were over-hyped, perhaps.

    This is good news.

    Younger thinks that the glia (in brain) are instigators and maintainers of pain in FM.
    Last edited: Jan 8, 2022
    Ash, alktipping, Lilas and 3 others like this.
  4. Arnie Pye

    Arnie Pye Senior Member (Voting Rights)

    Quite a few people with hypothyroidism swear by LDN, and have said that it helps reduce pain and symptom severity. I've wondered a few times about trying it, but don't know how to get hold of it. I know it can be done - some people get it via a doctor in Glasgow (I think), but that's all I know. I haven't pursued the subject but one day I might.
    Ash likes this.
  5. Sbag

    Sbag Senior Member (Voting Rights)

    I am taking LDN after being prescribed by my consultant. It comes from Dicksons pharmacy in Scotland and costs less than £30 a month. If your GP won’t prescribe you can pay for a phone consultation with one of their Drs and they can do it instead.

    I have found it has really helped with my nerve pain - I used to get screaming pain in my legs and arms at night but now it happens very rarely.

    it takes a while to find the right dose and it can exacerbate symptoms before things settle down.
    Arnie Pye and Ash like this.
  6. Remain in Light

    Remain in Light Established Member (Voting Rights)

    I have tried this and thought it gave general improvement , until it didn't.
    Available via an American online pharmacy from India . Took about 3 weeks to the UK and cheaper than a private prescription, if I could get such a thing.
    Lots of stuff on the web about titration, dosage , etc. All straight forward.
    ukxmrv and Arnie Pye like this.

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