Quote:
Originally Posted by johnt
"At the 340 mg dose level there was a statistically significant improvement in overall Parkinson's disease clinical status, including LID, versus placebo as measured by physicians using the CGI-C (p=0.0036)."
At first sight that sounds like good news, but I would like to know:
1. ADS-5102 is measured against the placebo. Would it not make sense to measure it against immediate release amantadine?
2. Success is reported for the 340mg dose. The trial included also 260mg and 420 mg doses. What was the outcome for these?
3. Success was reported for the change in UDysRS. Other measures were used such as diaries and MDS-UPDRS. Do these also show improvements?
4. It seems to me that the obvious measurement that would be understandable to lay people would be before and after values of daily hours with LID together with standard Parkinson's parameters. What are the size of these improvements?
John
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All good questions, John. I don't have a link to actual analytical results, but I do have some notes I jotted down from a conference call, so I can't vouch for 100% accuracy. That being said, this is some additional information that I have:
* Yes, it would be interesting to see results against plain old original Amantadine. I don't know if Adamas has that information, but this trial was not designed that way.
* Both the 340mg and 420mg dose levels significantly reduced LID on the primary endpoint. However, there was no significant improvement from 340 to 420, so the Phase III study will focus only on 340mg. The 260mg group did have a 5 point improvement on the UDysRS, but the result wasn't statistically significant (p=.15). This could possibly change with a larger Phase III sample size, but I don't think they intend to test the lower dosage again. By comparison, the 340mg group had a mean improvement compared to placebo of over 11 points.
* There were many secondary outcome measurements. Not all were significant but many were, including:
- All three doses significantly increased On Time with Troublesome Dyskinesia according to the patient diaries (approximately 3 hours for all doses).
- All three doses significantly improved functional impact as measured by the MDS-UPDRS part IV.
- The drug was generally well tolerated, consistent with the known history of Amantadine use with PD.
I'll post more info if I get it.