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Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial.
Mov Disord. 2010 Dec 15; 25(16):2724-7.MD

Abstract

Levodopa use in fluctuating Parkinson's disease (PD) is complicated by an inconsistent and prolonged onset to clinical improvement. An orally dissolved carbidopa/levodopa (OD C/L) preparation (Parcopa UCB Pharma) is available in the United States. This offers potential advantages to shorten the duration from ingestion to clinical improvement. Surprisingly, this has never been clinically assessed. We tested 20 patients with fluctuating PD and a Unified Parkinson's Disease Rating Scale (UPDRS) "off" motor score of ≥ 25 in a 2-day, single-dose, double-blind, double-dummy, crossover study. Patients arrived in the morning in the practically defined "off" state and were randomly assigned to receive identical doses of either oral C/L and OD placebo or OD C/L and oral C/L placebo on 1st day and the reverse combination on a 2nd day. After training, patients underwent bilateral hand tapping at baseline and every 5 minutes for 60 minutes after dose ingestion. Stride length (SL) was recorded at 5-minute intervals with an ambulatory gait monitor. Patients identified their subjective latency to "on" and noted drug preferences and adverse events. They also underwent a UPDRS motor examination at baseline and 60 minutes after dose. Twenty subjects [15 male, age 68.7 (9.7), PD duration 13.4 (6.8)] completed. There were no significant group differences in tapping speed, subjective time to "on," latency of increased SL, or overall preference. However, all trends did favor OD C/L. Adverse events were similar. This small pilot study did not show significant group differences favoring OD C/L; however, larger studies may be justified, and individual patients may benefit.

Authors+Show Affiliations

Department of Neurology, Baylor College of Medicine, Houston, Texas, USA. wondo@bcm.tmc.eduNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20925074

Citation

Ondo, William G., et al. "Comparison of Orally Dissolving Carbidopa/levodopa (Parcopa) to Conventional Oral Carbidopa/levodopa: a Single-dose, Double-blind, Double-dummy, Placebo-controlled, Crossover Trial." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 25, no. 16, 2010, pp. 2724-7.
Ondo WG, Shinawi L, Moore S. Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial. Mov Disord. 2010;25(16):2724-7.
Ondo, W. G., Shinawi, L., & Moore, S. (2010). Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial. Movement Disorders : Official Journal of the Movement Disorder Society, 25(16), 2724-7. https://doi.org/10.1002/mds.23158
Ondo WG, Shinawi L, Moore S. Comparison of Orally Dissolving Carbidopa/levodopa (Parcopa) to Conventional Oral Carbidopa/levodopa: a Single-dose, Double-blind, Double-dummy, Placebo-controlled, Crossover Trial. Mov Disord. 2010 Dec 15;25(16):2724-7. PubMed PMID: 20925074.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial. AU - Ondo,William G, AU - Shinawi,Lina, AU - Moore,Steven, PY - 2010/10/7/entrez PY - 2010/10/7/pubmed PY - 2011/4/9/medline SP - 2724 EP - 7 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov Disord VL - 25 IS - 16 N2 - Levodopa use in fluctuating Parkinson's disease (PD) is complicated by an inconsistent and prolonged onset to clinical improvement. An orally dissolved carbidopa/levodopa (OD C/L) preparation (Parcopa UCB Pharma) is available in the United States. This offers potential advantages to shorten the duration from ingestion to clinical improvement. Surprisingly, this has never been clinically assessed. We tested 20 patients with fluctuating PD and a Unified Parkinson's Disease Rating Scale (UPDRS) "off" motor score of ≥ 25 in a 2-day, single-dose, double-blind, double-dummy, crossover study. Patients arrived in the morning in the practically defined "off" state and were randomly assigned to receive identical doses of either oral C/L and OD placebo or OD C/L and oral C/L placebo on 1st day and the reverse combination on a 2nd day. After training, patients underwent bilateral hand tapping at baseline and every 5 minutes for 60 minutes after dose ingestion. Stride length (SL) was recorded at 5-minute intervals with an ambulatory gait monitor. Patients identified their subjective latency to "on" and noted drug preferences and adverse events. They also underwent a UPDRS motor examination at baseline and 60 minutes after dose. Twenty subjects [15 male, age 68.7 (9.7), PD duration 13.4 (6.8)] completed. There were no significant group differences in tapping speed, subjective time to "on," latency of increased SL, or overall preference. However, all trends did favor OD C/L. Adverse events were similar. This small pilot study did not show significant group differences favoring OD C/L; however, larger studies may be justified, and individual patients may benefit. SN - 1531-8257 UR - https://www.unboundmedicine.com/medline/citation/20925074/Comparison_of_orally_dissolving_carbidopa/levodopa__Parcopa__to_conventional_oral_carbidopa/levodopa:_A_single_dose_double_blind_double_dummy_placebo_controlled_crossover_trial_ L2 - https://doi.org/10.1002/mds.23158 DB - PRIME DP - Unbound Medicine ER -