Landmark 165 · Trial in people
PROUD: pramipexole delayed start
Starting pramipexole straight away, rather than 6 to 9 months later, made no lasting difference in 535 people. It eases symptoms but does not slow Parkinson's.
In short
In 535 people, starting pramipexole at once rather than 6–9 months later made no lasting difference to symptoms or to dopamine-transporter scans.
- What it is
- Trial in people
- Outcome
- Did not work
- When
- 2013
- Size
- 535 people · Phase 3
- Research lane
- Trial methods & regulation
- Trial registry
- NCT00321854
- Last checked
- 19 Oct 2026
The research record
This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".
Who
Anthony Schapira, Michael McDermott, Kenneth Marek and colleagues, funded by Boehringer Ingelheim; 98 centres. Lancet Neurology, 2013.
What happened
Pramipexole is a dopamine agonist, a drug that stimulates dopamine receptors directly. The imaging trials in landmark 163 suggested it might slow nerve loss. PROUD used the delayed-start design of landmark 162 to test that.
- Design. 535 people with Parkinson's diagnosed within 2 years (aged 30–79), recruited 24 May 2006 to 22 April 2009 (NCT00321854). 261 got pramipexole 1.5 mg a day and 274 placebo; at 9 months (as early as 6 if needed) placebo people switched to pramipexole. Followed for 15 months.
- Result. At 15 months (411 people), total UPDRS (a severity score; higher is worse) differed by only −0.4 points (95% CI −2.2 to 1.4, p=0.65). The authors found little to separate 15 months of pramipexole from treatment delayed by 6-9 months.
- Scans. In a 123-person sub-study, striatal FP-CIT binding fell 15.1% (early) versus 14.6% (delayed), p=0.84.
- Safety. Serious events 22 people (10%) early versus 17 (8%) delayed; two (hallucinations and orthostatic hypotension) were judged drug-related.
Why it moved us toward a cure
It put an end to the claim that dopamine-agonist scan results mean protection, and showed again that a delayed-start comparison is needed to separate symptom relief from slowing.
Outcome
Dead end for pramipexole as a disease-slower. The authors concluded the results did not support disease modification.
Sources
- Schapira et al., Lancet Neurol 2013, doi:10.1016/S1474-4422(13)70117-0 · ClinicalTrials.gov NCT00321854
- Europe PMC abstract: PMID 23726851
- Not yet verified: the page number; the 6-9 month early-treatment advantage (removed; abstract does not state it).
How it connects
Built on
- uses TEMPO: rasagiline delayed start · 2002
- tests CALM-PD β-CIT and REAL-PET · 2002
Led to
None recorded.