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Subcutaneous apomorphine in patients with advanced Parkinson's disease: a dose-escalation study with randomized, double-blind, placebo-controlled crossover evaluation of a single dose.
J Neurol Sci. 2007 Jul 15; 258(1-2):137-43.JN

Abstract

OBJECTIVE

To further explore the efficacy and safety of subcutaneous apomorphine (APO) in treating off episodes in APO-naïve patients with advanced Parkinson's disease (PD).

METHODS

56 patients receiving optimized oral anti-PD medication were evaluated on separate days for response to single increasing doses of APO. Acute response to oral anti-PD medication and APO dose escalation (2-10 mg) was evaluated under unblinded conditions. At the 4 mg APO dose, placebo was randomly introduced under double-blind crossover conditions.

RESULTS

Mean changes from pre-dose in Unified Parkinson's Disease Rating Scale motor scores indicated significant improvement following APO 4 mg versus placebo at 20 min (p=0.0002), 40 min (p<0.0001; maximum improvement) and 90 min (p=0.0229). Improvements showed significant dose-response at 20 min, 40 min (both p<0.0001) and 90 min (p=0.0049). Adverse events were more common with APO than placebo, and also showed significant dose-response (p<0.0001). Common adverse events associated with APO included yawning, dizziness, nausea, somnolence and dyskinesias, and were generally mild to moderate. There were no significant differences between APO and placebo in the incidence of hypotension associated with a postural change from a sitting to standing position.

CONCLUSIONS

Subcutaneous APO provided rapid, effective relief of off episodes associated with advanced PD.

Authors+Show Affiliations

University of Kansas Medical Center, 3599 Rainbow Blvd, Kansas City, KS 66160, USA. rpahwa@kumc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

17466338

Citation

Pahwa, Rajesh, et al. "Subcutaneous Apomorphine in Patients With Advanced Parkinson's Disease: a Dose-escalation Study With Randomized, Double-blind, Placebo-controlled Crossover Evaluation of a Single Dose." Journal of the Neurological Sciences, vol. 258, no. 1-2, 2007, pp. 137-43.
Pahwa R, Koller WC, Trosch RM, et al. Subcutaneous apomorphine in patients with advanced Parkinson's disease: a dose-escalation study with randomized, double-blind, placebo-controlled crossover evaluation of a single dose. J Neurol Sci. 2007;258(1-2):137-43.
Pahwa, R., Koller, W. C., Trosch, R. M., & Sherry, J. H. (2007). Subcutaneous apomorphine in patients with advanced Parkinson's disease: a dose-escalation study with randomized, double-blind, placebo-controlled crossover evaluation of a single dose. Journal of the Neurological Sciences, 258(1-2), 137-43.
Pahwa R, et al. Subcutaneous Apomorphine in Patients With Advanced Parkinson's Disease: a Dose-escalation Study With Randomized, Double-blind, Placebo-controlled Crossover Evaluation of a Single Dose. J Neurol Sci. 2007 Jul 15;258(1-2):137-43. PubMed PMID: 17466338.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Subcutaneous apomorphine in patients with advanced Parkinson's disease: a dose-escalation study with randomized, double-blind, placebo-controlled crossover evaluation of a single dose. AU - Pahwa,Rajesh, AU - Koller,William C, AU - Trosch,Richard M, AU - Sherry,James H, AU - ,, Y1 - 2007/04/27/ PY - 2006/08/17/received PY - 2007/03/13/revised PY - 2007/03/15/accepted PY - 2007/5/1/pubmed PY - 2007/8/19/medline PY - 2007/5/1/entrez SP - 137 EP - 43 JF - Journal of the neurological sciences JO - J Neurol Sci VL - 258 IS - 1-2 N2 - OBJECTIVE: To further explore the efficacy and safety of subcutaneous apomorphine (APO) in treating off episodes in APO-naïve patients with advanced Parkinson's disease (PD). METHODS: 56 patients receiving optimized oral anti-PD medication were evaluated on separate days for response to single increasing doses of APO. Acute response to oral anti-PD medication and APO dose escalation (2-10 mg) was evaluated under unblinded conditions. At the 4 mg APO dose, placebo was randomly introduced under double-blind crossover conditions. RESULTS: Mean changes from pre-dose in Unified Parkinson's Disease Rating Scale motor scores indicated significant improvement following APO 4 mg versus placebo at 20 min (p=0.0002), 40 min (p<0.0001; maximum improvement) and 90 min (p=0.0229). Improvements showed significant dose-response at 20 min, 40 min (both p<0.0001) and 90 min (p=0.0049). Adverse events were more common with APO than placebo, and also showed significant dose-response (p<0.0001). Common adverse events associated with APO included yawning, dizziness, nausea, somnolence and dyskinesias, and were generally mild to moderate. There were no significant differences between APO and placebo in the incidence of hypotension associated with a postural change from a sitting to standing position. CONCLUSIONS: Subcutaneous APO provided rapid, effective relief of off episodes associated with advanced PD. SN - 0022-510X UR - https://www.unboundmedicine.com/medline/citation/17466338/Subcutaneous_apomorphine_in_patients_with_advanced_Parkinson's_disease:_a_dose_escalation_study_with_randomized_double_blind_placebo_controlled_crossover_evaluation_of_a_single_dose_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-510X(07)00215-8 DB - PRIME DP - Unbound Medicine ER -