Parkinson’s Disease / 2020 / Article / Tab 5

Research Article

Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa

Table 5

Patients with select AEs and ADRs of special interest.

Phase III programPatients, n (%)
Levodopa <2000 mg/day (n = 340)Levodopa ≥2000 mg/day (n = 72)Overall (N = 412)

Abuse liability AEs
 Intentional overdose1 (0.3)1 (0.2)
 Psychomotor hyperactivity1 (1.4)1 (0.2)
Sleep/sleep attack-related AEs
 Sleep attacks30 (8.8)9 (12.5)39 (9.5)
 Somnolence8 (2.4)4 (5.6)12 (2.9)
Hallucination/psychosis-related AEs
 Hallucination25 (7.4)13 (18.1)38 (9.2)
 Hallucination, auditory4 (1.2)4 (1.0)
 Hallucination, tactile2 (0.6)2 (0.5)
 Hallucination, visual11 (3.2)1 (1.4)12 (2.9)
 Hallucination, mixed1 (0.3)1 (0.2)
 Psychotic disorder3 (0.9)3 (4.2)6 (1.5)
Polyneuropathy-related AEsa32 (9.4)17 (23.6)49 (11.9)
Polyneuropathy-related AEs reported in >1% of patients overallb
 Polyneuropathy15 (4.4)10 (13.9)25 (6.1)
 Peripheral neuropathy5 (1.5)1 (1.4)6 (1.5)
 Peripheral sensory neuropathy5 (1.5)1 (1.4)6 (1.5)

GLORIA registryLevodopa <2000 mg/day (n = 309)Levodopa ≥2000 mg/day (n = 47)Overall (N = 356)

Somnolence2 (0.6)1 (2.1)3 (0.8)
Hallucination/psychosis-related ADRsb
 Hallucination9 (2.9)3 (6.4)12 (3.4)
 Hallucination, visual1 (0.3)1 (2.1)2 (0.6)
 Psychotic disorder6 (1.9)1 (2.1)7 (2.0)
Polyneuropathy-related ADRsb reported in >1% of patients overall
 Polyneuropathy12 (3.9)4 (8.5)16 (4.5)
 Peripheral neuropathy4 (1.3)1 (2.1)5 (1.4)
 Peripheral sensory neuropathy1 (0.3)3 (6.4)4 (1.1)

aBased on the Standard MedDRA Query narrow search of Guillain–Barré syndrome and peripheral neuropathy. bPolyneuropathy AEs not listed in the table include Guillain–Barré syndrome, which occurred in two patients (n/N = 2/72, 2.8%) who required ≥2000 mg dose for PD symptom control. bADRs were AEs deemed by the investigator to have at least a reasonable possibility of a causal relationship to the treatment drug/device. ADR: adverse drug reaction; AE: adverse event; PD: Parkinson’s disease.

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