|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
5 June 2023 |
|
Main ID: |
NCT02577523 |
|
Date of registration:
|
06/10/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease
|
|
Scientific title:
|
A Multicenter, Parallel-group, Rater-blinded, Randomized Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of 2 Dosing Regimens of ND0612H [ ] in Subjects With Advanced Parkinson's Disease |
|
Date of first enrolment:
|
December 29, 2015 |
|
Target sample size:
|
38 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02577523 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Austria
|
Israel
|
Italy
|
United States
| | | | |
|
Contacts
|
|
Name:
|
Laurence Salin, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
NeuroDerm Ltd. |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Male and female PD subjects of any race aged 30 to 80 years who sign an Institutional
Review Board/Ethics Committee (IRB/EC)-approved informed consent form (ICF).
2. PD diagnosis consistent with the UK Brain Bank Criteria.
3. Modified Hoehn & Yahr scale in "ON" state of stage =3.
4. Taking at least 4 doses/day of LD (or at least 3 doses/day of Rytary) and taking, or
have attempted to take, at least 2 other classes of anti-PD medications in a
therapeutic dose for at least 30 consecutive days each.
5. Subjects must be stable on their anti-PD medications for at least 30 days before Day
1.
6. Subjects may have had prior exposure to SC apomorphine injections/infusion but must
have stopped administration at least 4 weeks before the screening visit. Treatment
with apomorphine is prohibited during the entire ND0612H treatment period.
7. Must have a minimum of 2.5 hrs of "OFF" time per day with predictable early morning
"OFF" periods as estimated by the subject.
8. Must have predictable and well defined early morning "OFF" periods with a good
response to LD for treatment of the early morning "OFF" in the judgement of the
investigator.
9. Mini Mental State Examination (MMSE) score >26.
10. No clinically significant medical, psychiatric or laboratory abnormalities which the
investigator judges would be unsafe or non-compliant in the study.
11. Female subjects must be surgically sterile, postmenopausal (defined as cessation of
menses for at least 1 year), or willing to practice a highly effective method of
contraception. All female participants must be non-lactating and non-pregnant and have
a negative urine pregnancy test at Screening and at Baseline. Female subjects of
childbearing potential must practice a highly effective method of contraception (e.g.,
oral contraceptives, a barrier method of birth control [e.g., condoms with
contraceptive foams, diaphragms with contraceptive jelly], intrauterine devices,
partner with vasectomy), 1 month before enrollment, for the duration of the study, and
3 months after the last dose of study drug.
12. Willingness and ability to comply with study requirements
Exclusion Criteria:
1. Atypical or secondary parkinsonism.
2. Acute psychosis or hallucinations in past 6 months.
3. Any relevant medical, surgical, or psychiatric condition, laboratory value, or
concomitant medication which, in the opinion of the Investigator or the eligibility
reviewer, makes the subject unsuitable for study entry or potentially unable to
complete all aspects of the study.
4. Prior neurosurgical procedure for PD, or duodopa treatment.
5. Subjects with a history of drug abuse or alcoholism within the past 12 months.
6. Clinically significant ECG rhythm abnormalities.
7. Renal or liver dysfunction that may alter drug metabolism including: serum creatinine
>1.3 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
>2 x upper limit of normal (ULN), total serum bilirubin >2.5 mg/dL.
8. Subjects who are not willing to operate the pump system.
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Parkinson's Disease
|
|
Intervention(s)
|
|
Drug: ND0612 (Levodopa/Carbidopa solution)
|
|
Drug: ND0612 (Levodopa/Carbidopa solution) + morning oral IR-LD/CD
|
|
Primary Outcome(s)
|
|
Change in Daily "OFF" Time
[Time Frame: Baseline to Day 28]
|
|
Secondary Outcome(s)
|
|
Change in PDSS-2 Total Score
[Time Frame: Baseline to Day 27]
|
|
Change in Daily "Good ON" Time as Assessed by a Blinded Rater
[Time Frame: Baseline to Day 28]
|
|
Change in PDQ-39 Summary Index and the 8-dimension Scores
[Time Frame: Baseline to Day 27]
|
|
Change in Morning UPDRS Part III (Motor) Scores
[Time Frame: Baseline to Day 28]
|
|
Change in UPDRS Part II (ADL) Scores
[Time Frame: Baseline to Day 28]
|
|
CGI-Improvement (CGI-I) Score as Assessed by Investigator
[Time Frame: Baseline to Day 28]
|
|
The Percentage of Subjects With Full "ON" at Approximately 08:00 and Approximately 09:00, as Determined by the Subject
[Time Frame: Baseline to Day 28]
|
|
Secondary ID(s)
|
|
ND0612H-006
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|