Efficacy and safety of intravenous prasinezumab in individuals with early-stage Parkinson's disease on stable symptomatic monotherapy (PADOVA): a phase 2b, multicentre, randomised, double-blind, placebo-controlled study.

What was studied

This study tested a drug called prasinezumab in people with early Parkinson's disease. All of them already took a steady drug for their symptoms. They were 50-85 years old. They had had the disease for 3 months to 3 years. People were put into groups by chance. One group got prasinezumab into a vein every 4 weeks. The other group got a dummy drip with no drug in it. Neither the people nor the doctors knew who got which. The trial ran at 110 centres in Europe and North America.

What they found

In total, 586 people took part, with 293 in each group. The main goal was the time until movement signs got clearly worse. The trial did not reach this main goal. The drug group showed a delay in worsening, but it was not significant. The middle time to worsening was 61·1 weeks with the drug. It was 49·7 weeks with the dummy drip. Serious harms were about as common in both groups. They hit 34 of 292 people on the drug. They hit 34 of 290 people on the dummy drip. The drug group had 1 death, and the dummy group had 2. None was linked to the drug.

What it means for patients

In this trial, the drug did not clearly slow the worsening of movement signs. Still, the authors say planned extra checks hint the drug may have an effect. They feel this backs further study of the drug. A phase 3 trial called PARAISO is now under way to test it more.

Why it is not certain yet

The main result was not significant, so the delay may be due to chance. The hints of an effect came only from extra checks, not the main test. The abstract does not give the details of those extra checks. The trial only took people with early disease on a steady symptom drug. The phase 3 trial has yet to show if the drug works.

Source

Efficacy and safety of intravenous prasinezumab in individuals with early-stage Parkinson's disease on stable symptomatic monotherapy (PADOVA): a phase 2b, multicentre, randomised, double-blind, placebo-controlled study.

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