L-dopa usually comes in two different formats : either the immediate release version, which satisfies the immediate need for L-dopa, or the controlled release version, which avoids the excessive effects of L-dopa by spreading out the effect over time. Dual layer L-dopa (IPX066), which is being developed for the treatment of Parkinson's Disease, has the advantages of both by combining the two types of L-dopa.
A randomized, double-blind, placebo-controlled, clinical trial of IPX066 assessed three dosages of L-dopa : 145mg, 245mg or 390mg taken three times daily. The main efficacy measure was the Parkinson's Disease symptom score, the Unified Parkinson's Disease Rating Scale (UPDRS), and also the Parkinson's Disease Questionnaire (PDQ-39).
All three dosages improved Parkinson's Disease, with the 145mg dosage, then the 245mg dosage giving better results. The most commonly reported adverse events with IPX066 included nausea, dizziness, and headache. No unexpected drug-related serious adverse events were reported.
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