Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's Disease
Status:
Completed
Trial end date:
2020-04-20
Target enrollment:
Participant gender:
Summary
In patients with Parkinson's disease, the characteristic motor symptoms, i.e., slowness of
movement (bradykinesia), tremor and rigidity, are consequences of the progressive
degeneration of neurons containing and releasing dopamine. The first-line treatment of
Parkinson´s is oral administration of levodopa - a precursor to dopamine that (unlike
dopamine) passes the blood brain barrier. After the first few years of treatment with
levodopa, many patients do however develop a highly variable response to the drug
characterised by rapid shifts between impaired locomotion and drug induced dyskinesias
(referred to as the on-off syndrome). This is cased by the marked variation in serum levodopa
levels following per oral administration, and it is known that intravenous administration of
levodopa give a more stable level of levodopa with improved on-off symptoms.
Levodopa-carbidopa intestinal gel (LCIG) - under the name of Duodopa® - is delivered directly
to the proximal jejunum via a tube connected to a portable infusion pump. Infusion of Duodopa
in the jejunum bypasses gastric emptying, helping to avoid the fluctuation in plasma levodopa
levels. However, while clearly confirming that an even administration of levodopa is of
considerable benefit to Parkinson patients with on-off symptomatology, the LCIG approach is
marred by the need for surgery (for the insertion of the intestinal tube) and various
possible complications following this, as well as by side effects such as abdominal pain.
Researchers have now succeeded in producing a physiologically acceptable levodopa solution
(called Infudopa) in a concentration allowing for a continuous intravenous (i.v.) or
subcutaneous (s.c.) administration of therapeutic doses to humans. Early experience of this
strategy confirms that both s.c. and i.v. administration of this solution results in even
serum levodopa levels and markedly improved motor functioning. The aim of this study is to
compare the pharmacokinetic profile of Infudopa administered i.v. and s.c. with that of
Duodopa administered enterally in parkinsonian patients with on-off complications.
Phase:
Phase 1
Details
Lead Sponsor:
Vastra Gotaland Region
Collaborators:
Dizlin Medical Design AB Göteborg University The Swedish Research Council
Treatments:
Carbidopa Carbidopa, levodopa drug combination Levodopa