HP 184 phase two trial beginning

woblybob · 01-24-2005, 09:22 PM

Introduction
we are inviting you to participate in a clinical research study titled "phase two, double-blind, placebo-controlled, multicentre study to assess the efficacy and safety of HP 184 at 100, 200 and 400 mg doses administered orally once daily for 24 weeks in adult patients with chronic spinal cord injury (CSCI)". Aventis Pharma pty Limited is acting as the local Australian sponsor of the study.

This is a clinical research study for new medicine called HP 184. Aventis Pharma proprietor Ltd (aka the sponsor) to develop this new medicine have not decided what HP 184 should be called as it is still in the early stages of research and development. This guard has not been approved by the Food and Drug Administration or the therapeutic goods administration. The FDA in the US and the TGA in Australia are organisations that decide which medicines can be registered for use. The use of HP 184 is therefore experimental. This research study has been approved by Austin health human research ethics committee.

Purpose

the main reason we are doing the research study is to measure the effect of HP 184 on muscle strength by comparing it to placebo (which is tablet that looks like the drug that does not contain any HP 184). We do this by measuring muscle power sensory perception and pain sensation at the beginning of the study and again after 24 weeks of treatment with the study drug HP 184 in patients who have chronic spinal cord injury. For this assessment selected muscles of the body are graded from nought to five.

Some improvement was observed in patients who took the study drug HP 184 for 11 days in the areas of, muscle strength, sensory perception, and pain sensation. However, long-term treatment is required to confirm this is the action of HP 184 and this is why we are asking you to participate in this research study the study drug HP 184 works by preventing the entry of sodium and potassium ions three nerves. This means it improves the functioning of nerves. About 240 chronic spinal cord injury patients between the ages of 18 to 35 will take part in the study of approximately 30 to 35 study centres in Australia, New Zealand, India, America, the UK and Europe. There will be about 10 patients in the study at this hospital. Please take your time to make your decision. Discuss with your family and friends. It is important that you read and understand several general principles apply to all the take part in our studies. Participation in the study is entirely voluntary, you are not obliged to take part. You treatment and the attitude of your doctor towards you will not be affected should you decide not to take part in the study. If you do not wish to being the study it will not affect any benefits to which you are entitled to. If you decide to take part you will need to sign to say that you have given your consent to participate. If you agree to participate, you may withdraw from the study at any time without affecting any benefits to which you would otherwise be entitled. Although for your own safety it is important to you to informed the study doctor.

There is another eight pages, but it just goes on to say what to expect from the trial, tests that they are going to run during the trial and how they measure them.

The Austin hospital is in charge of the Victorian spinal unit (Australia).

Just thought I would let you'se know, in case anybody was interested or is interested, I would be happy to keep you informed on the trial and how it progresses from my perspective or what I find out about how other people are going.

"If neccessity is the mother of invention,Sci cure is one mother of a neccessity".

picdev · 03-22-2005, 05:41 PM

yes I am interested in possible trying the drug Hp 184. I have C5 C6 injury with extreme butt,leg and feet nerve pain when I try to exercise. I can walk with canes and ride a recumbant bicycle but burn and hurt 6 to 24 hrs. after exercise. It has intensified over the past 2 1/2 years to the point I can hardly walk now. Would I be a candidate for this study. Brent Lane

Leo · 03-23-2005, 04:42 PM

ba lane, i just saw this also, keep us posted please.

"All you have to decide is what to do with the time that is given you."
Gandolf the Gray

lway2002 · 05-03-2005, 06:35 AM

woblybob, hi.
Are you in this trial? If so, do you have an update? When did the trial start?
Thanks in advance
Lway2002

DLN · 05-10-2005, 07:16 AM

this study is already in progess in Baltimore,Maryland at two locations...vetrans hospital and at kernan hospital

Tash · 05-20-2005, 01:32 AM

My partner has just entered the trial. I await updates and results with anticipation.

Tubby · 05-20-2005, 05:52 PM

I started this trial 10 weeks ago, was wondering if anyone else knows of any results in patients so i can compare.

midnight · 05-28-2005, 02:11 AM

Quote:

Originally posted by Tubby:

I started this trial 10 weeks ago, was wondering if anyone else knows of any results in patients so i can compare.

midnight · 05-28-2005, 02:14 AM

Quote:

Originally posted by Tubby:

I started this trial 10 weeks ago, was wondering if anyone else knows of any results in patients so i can compare.

Hi, I started the trial this week. Early days for me, so far.

IanTPoulter · 04-24-2006, 10:34 PM

Any updates on these trials?

01-24-2005, 09:22 PM	#1
woblybob Member Join Date: Aug 2001 Location: Victoria,Australia Posts: 58	HP 184 phase two trial beginning Introduction we are inviting you to participate in a clinical research study titled "phase two, double-blind, placebo-controlled, multicentre study to assess the efficacy and safety of HP 184 at 100, 200 and 400 mg doses administered orally once daily for 24 weeks in adult patients with chronic spinal cord injury (CSCI)". Aventis Pharma pty Limited is acting as the local Australian sponsor of the study. This is a clinical research study for new medicine called HP 184. Aventis Pharma proprietor Ltd (aka the sponsor) to develop this new medicine have not decided what HP 184 should be called as it is still in the early stages of research and development. This guard has not been approved by the Food and Drug Administration or the therapeutic goods administration. The FDA in the US and the TGA in Australia are organisations that decide which medicines can be registered for use. The use of HP 184 is therefore experimental. This research study has been approved by Austin health human research ethics committee. Purpose the main reason we are doing the research study is to measure the effect of HP 184 on muscle strength by comparing it to placebo (which is tablet that looks like the drug that does not contain any HP 184). We do this by measuring muscle power sensory perception and pain sensation at the beginning of the study and again after 24 weeks of treatment with the study drug HP 184 in patients who have chronic spinal cord injury. For this assessment selected muscles of the body are graded from nought to five. Some improvement was observed in patients who took the study drug HP 184 for 11 days in the areas of, muscle strength, sensory perception, and pain sensation. However, long-term treatment is required to confirm this is the action of HP 184 and this is why we are asking you to participate in this research study the study drug HP 184 works by preventing the entry of sodium and potassium ions three nerves. This means it improves the functioning of nerves. About 240 chronic spinal cord injury patients between the ages of 18 to 35 will take part in the study of approximately 30 to 35 study centres in Australia, New Zealand, India, America, the UK and Europe. There will be about 10 patients in the study at this hospital. Please take your time to make your decision. Discuss with your family and friends. It is important that you read and understand several general principles apply to all the take part in our studies. Participation in the study is entirely voluntary, you are not obliged to take part. You treatment and the attitude of your doctor towards you will not be affected should you decide not to take part in the study. If you do not wish to being the study it will not affect any benefits to which you are entitled to. If you decide to take part you will need to sign to say that you have given your consent to participate. If you agree to participate, you may withdraw from the study at any time without affecting any benefits to which you would otherwise be entitled. Although for your own safety it is important to you to informed the study doctor. There is another eight pages, but it just goes on to say what to expect from the trial, tests that they are going to run during the trial and how they measure them. The Austin hospital is in charge of the Victorian spinal unit (Australia). Just thought I would let you'se know, in case anybody was interested or is interested, I would be happy to keep you informed on the trial and how it progresses from my perspective or what I find out about how other people are going. "If neccessity is the mother of invention,Sci cure is one mother of a neccessity".

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03-22-2005, 05:41 PM	#2
picdev Junior Member Join Date: Mar 2005 Location: Amarillo,Tx 79109 Posts: 1	yes I am interested in possible trying the drug Hp 184. I have C5 C6 injury with extreme butt,leg and feet nerve pain when I try to exercise. I can walk with canes and ride a recumbant bicycle but burn and hurt 6 to 24 hrs. after exercise. It has intensified over the past 2 1/2 years to the point I can hardly walk now. Would I be a candidate for this study. Brent Lane

03-23-2005, 04:42 PM	#3
Leo Senior Member Join Date: Jul 2001 Location: Yankton, South Dakota Posts: 3,951	ba lane, i just saw this also, keep us posted please. "All you have to decide is what to do with the time that is given you." Gandolf the Gray

05-03-2005, 06:35 AM	#4
lway2002 Senior Member Join Date: Feb 2002 Posts: 223	woblybob, hi. Are you in this trial? If so, do you have an update? When did the trial start? Thanks in advance Lway2002

05-10-2005, 07:16 AM	#5
DLN Junior Member Join Date: Mar 2003 Posts: 3	this study is already in progess in Baltimore,Maryland at two locations...vetrans hospital and at kernan hospital

05-20-2005, 01:32 AM	#6
Tash Junior Member Join Date: May 2005 Posts: 21	My partner has just entered the trial. I await updates and results with anticipation.

05-20-2005, 05:52 PM	#7
Tubby Junior Member Join Date: Nov 2003 Location: New Jersey Posts: 2	I started this trial 10 weeks ago, was wondering if anyone else knows of any results in patients so i can compare.

04-24-2006, 10:34 PM	#10
IanTPoulter Senior Member Join Date: Dec 2005 Location: Perth Western Australia Posts: 5,197	Any updates on these trials?