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-   -   Recruitment has begun for the Georgetown University "PD Nilotinib" phase 2 trial (https://www.neurotalk.org/parkinson-s-disease/244944-recruitment-begun-georgetown-university-pd-nilotinib-phase-2-trial.html)

jeffreyn 02-11-2017 01:22 AM

Recruitment has begun for the Georgetown University "PD Nilotinib" phase 2 trial
 
On the Clinical Trials website, the project description for the Georgetown University "PD Nilotinib" phase 2 trial has recently been updated.

The "Estimated Study Completion Date" is now given as "July 2020".

Recruitment has now begun.

In an email to me in November last year GU said that for their Nilotinib trials they will only be recruiting patients who live within 50 miles of Georgetown University Hospital in Washington DC. I would imagine that this is still the case (assuming that they have no trouble getting their 75 recruits).

Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease - Full Text View - ClinicalTrials.gov

From another source I also have the following information:
- GU has convinced the drug maker Novartis to provide Nilotinib and matching placebo to the PD trial;
- They also have approval for drug donation for an extension trial in PD that will follow the double-blind placebo-controlled trial. The extension trial will be open-label, where all participants in the double-blind trial will receive the drug for one year.

Tupelo3 02-11-2017 11:03 AM

Quote:

Originally Posted by jeffreyn (Post 1236273)
On the Clinical Trials website, the project description for the Georgetown University "PD Nilotinib" phase 2 trial has recently been updated.

The "Estimated Study Completion Date" is now given as "July 2020".

Recruitment has now begun.


In an email to me in November last year GU said that for their Nilotinib trials they will only be recruiting patients who live within 50 miles of Georgetown University Hospital in Washington DC. I would imagine that this is still the case (assuming that they have no trouble getting their 75 recruits).

Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease - Full Text View - ClinicalTrials.gov

From another source I also have the following information:
- GU has convinced the drug maker Novartis to provide Nilotinib and matching placebo to the PD trial;
- They also have approval for drug donation for an extension trial in PD that will follow the double-blind placebo-controlled trial. The extension trial will be open-label, where all participants in the double-blind trial will receive the drug for one year.


GU study is very restrictive. Besides the travel radius, it is only open for PWP with either a 2.5 or 3 H&Y staging. The MJFF et al trial will begin in the summer. There will be 20 to 25 test sites across the country, which will open it up for many more of us.

jeffreyn 02-14-2017 08:18 PM

Uncertainty regarding one aspect of the GU Phase 1 results
 
Could MAO-B Inhibitor Withdrawal Rather than Nilotinib Benefit Explain the Dopamine Metabolite Increase in Parkinsonian Study Subjects?

Could MAO-B Inhibitor Withdrawal Rather than Nilotinib Benefit Explain the Dopamine Metabolite Increase in Parkinsonian Study Subjects? - IOS Press

jeffreyn 02-26-2017 07:05 PM

Press Release from GU for their "PD Nilotinib" Phase II Trial
 
Georgetown University have recently issued a press release announcing the start of their "PD Nilotinib" Phase II trial.

As far as I can see, the press release contains no new information from what we already have in this thread. However, some may find the information in the press release to be in a more-readable form than that in the "trial record" on the Clinical Trials website.

Georgetown Announces Phase II Clinical Trial of Nilotinib for Parkinson’s Disease | Georgetown University Medical Center | Georgetown University


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