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https://www.biospace.com/article/releases/phase-2-clinical-trial-of-lsd-for-and-quot-suicide-headaches-and-quot-begins-treating-patients/?fbclid=IwAR2i4zGnc86d3Hijjzi4vxCBi87AlgJvc5Naeh0wlcXhQP-bgCKFc_h5YZM

Phase 2 Clinical Trial of LSD for "Suicide Headaches" Begins Treating Patients

Published: Jun 08, 2020

MindMed Is Collaborating on a Phase 2 Clinical Trial of LSD For Cluster Headaches with University Hospital Basel's Liechti Lab

BASEL, Switzerland, June 8, 2020 /PRNewswire/ -- Mind Medicine (MindMed) Inc. (NEO: MMED OTCQB: MMEDF), is supporting and collaborating on a Phase 2 clinical trial evaluating LSD for the treatment of cluster headaches at University Hospital Basel's Liechti Lab. The Phase 2 trial began recruiting patients in early January and has commenced treating patients with LSD.

Artistic rendering courtesy of MindMed (PRNewsfoto/Mind Medicine (MindMed) Inc.)

MindMed is the leading neuro-pharmaceutical company for psychedelic inspired medicines and previously formed an ongoing R&D collaboration with the University Hospital Basel's Liechti Lab, the leading global clinical research laboratory for LSD, to evaluate multiple therapeutic uses of psychedelics and next-gen psychedelic therapies. This new development is part of the collaboration and Dr Matthias Liechti is serving as principal investigator of the clinical trial.

Cluster headaches, also known as "suicide headaches," due to the severity of the pain caused are often viewed as one of the most profoundly painful conditions known to mankind. The pain occurs on one side of the head or above an eye and can last for weeks or months. Studies have demonstrated increased suicidality associated with patients experiencing cluster headache attacks.

Non-clinical and anecdotal evidence suggests LSD can abort attacks and decrease the frequency and intensity of the attacks. There is a need for new treatment approaches for cluster headaches as current available medications often mismanage cluster attack periods.

The Phase 2 trial is investigating the effects of an oral LSD pulse regimen (3 x 100 µg LSD in three weeks) in 30 patients suffering from Cluster Headaches compared with placebo. The study is a Double-blind, randomized, placebo-controlled two-phase cross-over study design.

MindMed Co-founder & Co-CEO JR Rahn said "As we continue on our mission to discover, develop and deploy psychedelic inspired medicines, we are very encouraged to bring this potential treatment for cluster headaches using LSD out of the shadows and evaluate its efficacy based on clinical research standards with the Liechti Lab."

MindMed's collaboration will assess if there is clinical evidence for a future commercial drug trial through the FDA pathway at a later date. Treatments for cluster headaches may potentially qualify for an Orphan Drug Designation and be eligible for certain development incentives provided by the FDA for rare diseases.

Liechti Lab and MindMed intend to learn how they can make the administration of LSD more targeted for cluster headache patients through this Phase 2 trial and future clinical trials. As part of the collaboration with UHB Liechti Lab, MindMed gains exclusive, global use to all data and IP generated in the Phase 2 trial of LSD for cluster headaches.

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1 hour ago, My Favourite Headache said:

It's a shame they don't do a parallel trial with BOL-148.

I was kind of surprised that this wasn't actually a BOL trial. (For those that don't know, BOL-148 is a whole lot of LSD, many times the recreational dose, that is rendered non-hallucinogenic by the addition of another molecule (brromine).)  I know there were issues with another company's attempts to bring BOL to market for CH, and I know some of those issues were related to licensing rights and fees.  Or something.  Anyway, it could be that there's a "business" side to this choice.

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On 6/11/2020 at 11:21 PM, CHfather said:

I was kind of surprised that this wasn't actually a BOL trial. (For those that don't know, BOL-148 is a whole lot of LSD, many times the recreational dose, that is rendered non-hallucinogenic by the addition of another molecule (brromine).)  I know there were issues with another company's attempts to bring BOL to market for CH, and I know some of those issues were related to licensing rights and fees.  Or something.  Anyway, it could be that there's a "business" side to this choice.

There certainly is more interest and business possibilities to this. It's still a shame to have BOL go forgotten (or has it been - I don't know).

I am still overjoyed with this ! Our world will change with this and psilocybin research.

https://m.facebook.com/story.php?story_fbid=164303895107031

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After reading this thread I started to look for clinical trials in the UK that I might volunteer for - I contacted the Beckley Foundation as they were involved with BOL-148 trials  www.beckleyfoundation.org .

I got a response from them today - thgey're not currently doing any trials but said that there are two clinical trials recruiting participants for psilocybin and cluster headaches: One at the Rigshospitalet’s Neurobiology Research Institute in Copenhagen, Denmark (Contact: Gitte Moos Knudsen, +4535456720, gmk@nru.dk), and one in West Haven, Connecticut, USA (Contact: Emmanuelle Schindler, 203-932-5711 ext 4335, emmanuelle.schindler@yale.edu; or Christina Forte, 203-932-5711, ext 2526, christina.forte@yale.edu).

 

Thought I'd pass this on in case anyone wants to volunteer

Phil

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