Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal
NCT ID: NCT03541356
Last Updated: 2020-08-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2018-05-08
2019-06-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
In Cohort 4 the INP103 formulation will contain L-dopa:carbidopa administered nasally. Dosing will take place once OFF episode is confirmed and will not include predosing with oral benserazide.
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Delivered via the I231 POD (Precision Olfactory Delivery) device
L-dopa 35 mg
L-dopa 35 mg
Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
L-dopa 70 mg
L-dopa 70mg
Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
L-dopa 140 mg
L-dopa 140 mg
Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
L-dopa 70 mg/carbidopa 7 mg
L-dopa 70mg/carbidopa 7mg
Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
Interventions
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Placebo
Delivered via the I231 POD (Precision Olfactory Delivery) device
L-dopa 35 mg
Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
L-dopa 70mg
Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
L-dopa 140 mg
Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
L-dopa 70mg/carbidopa 7mg
Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with Idiopathic PD (by UK Brain Bank Criteria) with Modified Hoehn \& Yahr (H\&Y) Stage I-III during an ON period at Visit 1
3. Subjects who are prone to (and recognize) OFF episodes (when their usual PD medication has worn off)
4. Shown to be responsive to L-dopa medication (≥ 30% improvement in MDS-UPDRS Part III Motor Examination score) as assessed during the Screening period (Visit 2)
5. On a stable dose of L-dopa containing medication for at least 2 weeks prior to Visit 1 (up to 1200 mg/day) with no single dose exceeding 250 mg. All other anti-PD medication (e.g. dopamine agonists \[DAs\], monoamine oxidase-B inhibitor (MAOB-I) or catechol-O-methyl transferase (COMT) inhibitors ARE allowed if the subject has been on a stable dose for at least 30 days prior to Visit 1.
6. Willing to omit their (usual) PD drugs (e.g. usual regular anti-PD medication including any L-dopa containing medication, DAs and/or COMT inhibitors and any required anti-OFF treatment) from 22:00 pm the evening prior to study dosing until 120 minutes post study treatment dosing.
Cohorts 1, 2 and 3 ONLY WILL take oral benserazide 25 mg on arrival at the research site (at 60 ± 5 minutes before dosing with INP103 or placebo).
Cohort 4 will omit oral benserazide and subjects may be dosed once OFF episode has been confirmed and all baseline assessments have been completed.
7. If female and of childbearing potential must agree to use adequate contraception (see Section 4.4) during the study
8. Able and willing to attend the necessary visits at the study centre
9. Willing to provide voluntary written informed consent signed prior to entry into the study
Exclusion Criteria
2. In receipt of L-dopa containing medication at \> 1200 mg/day
3. History of significant psychotic episode(s) within the previous 12 months in the opinion of the Investigator, or currently receiving anti-psychotic medication at a moderate dose (quetiapine \>50 mg/day, risperidone \>1 mg/day or olanzapine \>2.5 mg/day)
4. Mini Mental State Examination (MMSE) ≤ 25 as documented within the previous 36 months or as assessed by Investigator during Screening
5. History of suicidal ideation or attempted suicide within previous 12 months
6. Narrow-angle glaucoma
7. Presence of skin lesions that, in the opinion of the Investigator, may be cancerous
8. Females who are pregnant, planning a pregnancy or lactating
9. Subjects with any underlying physical condition that, in the opinion of the Investigator, would make it unlikely that the subject will comply with or be able to complete the study requirements
10. Use of any medication likely to interact with benserazide, carbidopa or INP103 (see Appendix 5)
11. Laboratory test abnormalities at Screening (Visit 1) deemed clinically significant by the Investigator.
12. History or presence of alcoholism or drug abuse within the 2 years prior to INP103 or placebo dosing
13. Administration of an investigational product in another trial within 30 days or 5 half-lives (whichever is longer) prior to INP103 or placebo dosing
14. Significant nasal congestion, physical blockage in either nostril, or significantly deviated nasal septum as evaluated by the PI or other suitably trained healthcare professional
15. Subjects who have previously shown hypersensitivity to L-dopa or benserazide (for Cohorts 1, 2 and 3), or L-dopa or carbidopa (for Cohort 4) or any of their excipients
40 Years
80 Years
ALL
No
Sponsors
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Impel Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen B Shrewsbury, MD
Role: STUDY_CHAIR
Impel NeuroPharma, Seattle, WA (USA)
Terry O'Brien, MD/Prof
Role: PRINCIPAL_INVESTIGATOR
The Alfred Hospital, Melbourne, VIC (AUS)
Locations
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The Brain and Mind Centre / Scientia Clinical Research
Sydney, New South Wales, Australia
Q-Pharm
Brisbane, Queensland, Australia
The Mater Hospital
Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Perron Institute
Perth, Western Australia, Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INP103-201
Identifier Type: -
Identifier Source: org_study_id
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