Trial Profile

A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 24 Jul 2024

Price :

$35 ^*

Note:

Adis is an information provider.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

Drugs Pramipexole/rasagiline (Primary) ; Pramipexole; Pramipexole; Rasagiline
Indications Parkinson's disease
Focus Registrational; Therapeutic Use
Sponsors Pharma Two B

22 Jul 2024 According to a Pharma Two B media release, the company is planning to file an NDA for P2B001 in first half of 2026.
18 Apr 2024 Integrated analysis Results(phase 2 (NCT01968460) and phase 3 (NCT03329508), n=199) evaluating safety and tolerability profile, presented at the 76th Annual Meeting of the American Academy of Neurology 2024
09 Nov 2023 Results presented in a Pharma Two B Media Release.

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com