Spinalon

[Wise Young]

How could drugs activate spinal CPGs? Is it that the drugs simply allow the CPG to be more easily excited? Or do they expect people to take a drug and suddenly see a locomotor like response in the legs?

tomsonsite, the central pattern generator CPG has receptors to neurotransmitters. Scientists have long known (like 50+ years) that it is possible to stimulate the CPG by injecting serotonin and other excitatory neurotransmitters intrathecally (into the cerebrospinal fluid surrounding the spinal cord). It has been a while since I looked at this trial but I assume that the spinalon combination is being injected intrathecally into patients with a pump (much like baclofen is injected but for shorter periods and under manual control, so that the person can apply the drug when walking is needed). One can of course stimulate the CPG electrically as well. Wise.

[Wise Young]

Hello all,

Newbie here.

Had a quick question re this - does the central pattern generator exist in those who have lumbar or sacral spinal injuries?

Very good question. The CPG is believed to be located at L2 spinal cord. Note that the L1-S5 spinal cord is located between the T11-L1 vertebral spinal canal. The sacral spinal cord segments are located in the spinal canal for the L1 vertebral segment. Below L1, you only have the cauda equina or spinal roots.

If you had a lower thoracic injury (i.e. T11, T12), you may have damaged the lumbar enlargement and the CPG. If you have a L1 or lower injury, your CPG may be intact.

Wise.

[GRAMMY]

tomsonsite, the central pattern generator CPG has receptors to neurotransmitters. Scientists have long known (like 50+ years) that it is possible to stimulate the CPG by injecting serotonin and other excitatory neurotransmitters intrathecally (into the cerebrospinal fluid surrounding the spinal cord). It has been a while since I looked at this trial but I assume that the spinalon combination is being injected intrathecally into patients with a pump (much like baclofen is injected but for shorter periods and under manual control, so that the person can apply the drug when walking is needed). One can of course stimulate the CPG electrically as well. Wise.

This study is a randomized, placebo-controlled, double-blind, single dose escalation study with fifty-one (51) patients who will receive either placebo capsules(starch) or capsules with buspirone only, levodopa/carbidopa only or buspirone/levodopa/carbidopa (SPINALON).

http://clinicaltrials.gov/show/NCT01484184

[Wise Young]

This study is a randomized, placebo-controlled, double-blind, single dose escalation study with fifty-one (51) patients who will receive either placebo capsules(starch) or capsules with buspirone only, levodopa/carbidopa only or buspirone/levodopa/carbidopa (SPINALON).

http://clinicaltrials.gov/show/NCT01484184

Grammy,

Thank you for correcting me. This is an oral drug. That is why I commented earlier about its possible effect on the heart and blood pressure. It will be interesting to see the results of the trial.

Wise.

[GRAMMY]

http://spinalcordresearchandadvocacy...dical-officer/

Nordic Life Science Pipeline Inc. names new acting Chief Medical Officer


They are planning to conduct a Spinalon phase II-B trial (expected for 2015) in US, Europe, Canada.

[tomsonite]

tomsonsite, the central pattern generator CPG has receptors to neurotransmitters. Scientists have long known (like 50+ years) that it is possible to stimulate the CPG by injecting serotonin and other excitatory neurotransmitters intrathecally (into the cerebrospinal fluid surrounding the spinal cord). It has been a while since I looked at this trial but I assume that the spinalon combination is being injected intrathecally into patients with a pump (much like baclofen is injected but for shorter periods and under manual control, so that the person can apply the drug when walking is needed). One can of course stimulate the CPG electrically as well. Wise.

Do CPG neurons respond to different neurotransmitters, or perhaps a specific combination of them, as opposed to other neurons? Or does the CPG act the way it does because of the neuronal "wiring", so to speak?

http://spinalcordresearchandadvocacy...dical-officer/

Nordic Life Science Pipeline Inc. names new acting Chief Medical Officer


They are planning to conduct a Spinalon phase II-B trial (expected for 2015) in US, Europe, Canada.

I had forgotten about this trial, I wonder how it's going. Can they get approval to do a phase II trial without first completing the phase I? Or can they just send the FDA the results without having the study published first?

[GRAMMY]

Do CPG neurons respond to different neurotransmitters, or perhaps a specific combination of them, as opposed to other neurons? Or does the CPG act the way it does because of the neuronal "wiring", so to speak?

I had forgotten about this trial, I wonder how it's going. Can they get approval to do a phase II trial without first completing the phase I? Or can they just send the FDA the results without having the study published first?

http://www.jneurosci.org/content/33/2/734.full.pdf

I believe the first trial was a 2 arm (Phase 1 and 2-A). The upcoming one would be a 2-B.

The current trial on 51 people had this organization on it for the Phase 1 & 2A.
The proposed study is a combination of 1 and 2-arm designs. First, a 2-arm design will be used, the first arm being composed of 3 subjects receiving the lowest dose of the study drug, and the second arm being composed of 1 subject receiving a placebo. This 2-arm design will be repeated consecutively (not simultaneously) with increasing doses of SPINALON, as long as the dose is well tolerated. Six (6) groups are expected to be tested with this 2-arm design.This will be followed by a 2-arm composed of 1 group with 1 subject receiving placebo and 1 larger group (10 subjects) who will receive SPINALON at MTD as identified in the previous 2-arm groups.

[GRAMMY]

The first Spinalon trial has been completed. LINK

[marvin_cr]

"This worldwide ground-breaking discovery enables preparation of the next step – that is even larger-scale studies (1000 patients) to seek approval for sales within 5 years in Canada, Europe and United States" Holy hell, still 5 yrs away. I will be dead in another three or four intervals of 5 yr

[Tbone57]

Another 2-3 five year intervals and I'll be dead also.