Status:
COMPLETED
Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's Disease
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
The Swedish Research Council
Dizlin Medical Design AB
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE1
Brief 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 con...
Detailed Description
IPO-001 is a prospective, randomized, 3-period cross-over, open-label multicentre trial comparing intravenous and subcutaneous Infudopa with intestinal Duodopa. The patients will be identified and rec...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Signed informed consent
- Male or female patients at least 30 years old
- Patients with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days, on a stable treatment regimen of 685 mg to 4000 mg levodopa per day, and with approximately 16- or 24-h Duodopa infusion regimens\*
- Patients with a Hoehn and Yahr (H\&Y) score of ≤ 3 on Duodopa treatment (including concomitant medication)
- Body mass index range from 18.0 to 35.0 kg/m2
- Patients in general good health, as judged by the Investigator, and as determined by vital signs, medical history, physical examination, ECG, and laboratory tests
- Females of childbearing potential must have a negative pregnancy test prior to randomization and must be willing to use a highly effective contraceptive measure during relevant systemic exposure to the investigational drug and the first menstrual cycle after treatment cessation (see section 7.3).
- Males must be willing to refrain from fathering a child, including sperm donation, during the study and 3 months following the last dose.
- Criterion 3 updated to "...a stable treatment regimen of 600 mg to 4000 mg levodopa per day" after first interim analysis (patient 6 and onwards)
- Exclusion Criteria\*\*:
- 1\. Simultaneous participation in any other clinical study 2. Known drug abuse of any kind, or other condition that may render the patient more likely to be non-compliant to the protocol, as judged by the investigator 3. Patients who are considered to be violent or patients considered at suicidal risk by the investigator 4. Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments 5. Patients with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions (previous brain surgery), any acute brain trauma requiring treatment with anticonvulsant therapy, or acute stroke 6. Current diagnosis or history of drug or alcohol abuse within 12 months of baseline 7. Other psychiatric, neurological, or behavioral disorders that may interfere with the conduct or interpretation of the study, as judged by the Investigator 8. History of, or current, seizure disorders and patients requiring treatment with anticonvulsants 9. History or presence of any condition that might interfere with absorption, distribution, metabolism, or excretion of study drug, however, the PEG/J (percutaneous endoscopic gastrojejunostomy) tube that Duodopa patients have is not considered as such condition 10. Patients on medication with warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, monoamine oxidase-A inhibitors and alpha-methyldopa (within last 60 days); selegiline, catechol-O-methyltransferase (COMT) inhibitors, dopamine, parenteral ergots, methylphenidate, amphetamine, beta blockers for treating tremor, isoprenaline, adrenaline, dobutamide, reserpine, flunarizine or cinnarizine, isoniazid, metoclopramide, and anticholinergics (within last 30 days); and iron salts (within last 7 days), or any other treatment that could affect the metabolism of levodopa 11. Patients who use antineoplastic and immunosuppressants (within the last 5 years), and drugs known to increase risks for cardiac toxicity, Torsade de Pointes, sudden death or prolonged QT interval (within five elimination half-lives before baseline and for the duration of the study)
- \*\*) Replaced by the following exclusion criteria after interim analysis (patient 6 and onwards):
- Simultaneous participation in any other clinical drug trial
- Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments.
- Patients with current serious symptomatic CNS-lesions, neurological, psychiatric, or behavioral disorders other than Parkinson's disease (e.g. major stroke, epilepsy, substance use disorder, previous neurosurgery including DBS) and that may interfere with the conduct or interpretation of the study
- History or presence of any condition that can interfere with absorption, distribution, metabolism, or excretion of study drug (not including the percutaneous endoscopic gastrojejunostomy tube needed for Duodopa administration)
- Patients on medication with warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, monoamine oxidase-A inhibitors and alpha-methyldopa (within the last 60 days); selegiline, catechol-O-methyltransferase (COMT) inhibitors other than a single daily dose of entacaponeparenteral ergots, anticholinergics, methylphenidate, amphetamine, isoprenaline, adrenaline, dobutamide, reserpine, or other drugs with known dopamine receptor antagonistic effect (within the last 30 days); and iron salts (within the last 7 days), or any other treatment that could affect the metabolism of levodopa
- Patients who use antineoplastic chemotherapy or biological immunosuppressants (within the last 5 years), and drugs known to increase risks for cardiac toxicity, Torsade de Pointes, sudden death or prolonged QT interval (within five elimination half-lives before baseline and for the duration of the study)
Exclusion
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03419806
Start Date
February 16 2018
End Date
April 20 2020
Last Update
November 5 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sahlgrenska Universtiy Hospital, Dep of Neurology
Gothenburg, Sweden