A Phase 2 interventional study of Placebo and L-dopa 35 mg in Parkinson's Disease, sponsored by Impel Pharmaceuticals. Completed at 5 sites in Australia. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Impel Pharmaceuticals · Phase 2, Interventional, and Treatment
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Among 51 studies testing levodopa in Parkinson Disease — 3 open to participants now, 3 under way, none of them phase 3. Levodopa · Parkinson Disease.
Among the 51 studies testing levodopa in Parkinson Disease, this one is the 35th largest by enrollment of the 50 interventional ones that give a count, is the only one that started in 2018, is one of 9 in phase 2, and was the 44th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →3 of the 51 studies testing levodopa in Parkinson Disease are open now, in 2 countries. Recruiting first, the newest first:
Second Affiliated Hospital of Soochow University · Sites in China
Ages 30–80
Emory University · Sites in United States
Ages 45–75 · Healthy volunteers
Beth Israel Deaconess Medical Center · Sites in United States
By country, each count listing its studies:
Levodopa: first FDA approval 1970 (LARODOPA), first EMA approval 2003. What it is approved for, and how studies give it, is on its page →
Of the 750 Parkinson Disease studies recruiting now, 312 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 190 take healthy volunteers.
This study: 40 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 11 · Phase 3 12 · Phase 4 17
First in 1998; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 56 across the 50 interventional studies. Of the 45 that completed or were terminated, 18 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
33 of 51 have an industry lead sponsor. The 10 most frequent:
Impel Pharmaceuticals is the lead sponsor of 5 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Impel Pharmaceuticals has 1 study filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
1 of the studies testing levodopa in Parkinson Disease that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06234995Emory UniversityCortical Electrophysiology of Response Inhibition in Parkinson's Disease | 2027-09 |
Add it to your calendar (.ics) → With an account.
Among the 51 studies testing levodopa in Parkinson Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of Decarboxylase Inhibitor to L-dopa Responsive Parkinson's Disease Patients
This is a Phase IIa randomized, double-blind, placebo-controlled, single dose study to compare the safety, tolerability and PK/PDyn of intranasal L-dopa following administration of INP103 in the presence of L-dopa decarboxylase inhibitor (DCI) during an OFF episode.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: Placebo
Combination Product: L-dopa 35 mg
Combination Product: L-dopa 70mg
Combination Product: L-dopa 140 mg
Combination Product: L-dopa 70mg/carbidopa 7mg
Delivered via the I231 POD (Precision Olfactory Delivery) device
Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
Drug page: Levodopa
Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
Number of Participants With Treatment Emergent Adverse Events
Assessment of treatment emergent adverse events after single dosing with INP103 (L-dopa or L-dopa/carbidopa)
Time frame: 7 days
AUC0-2hr for L-dopa
Area under the Plasma Concentration-time Curve for L-dopa from Time = 0 to Time = 2 hours post dose. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.
Time frame: For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 min
Cmax of L-dopa
Maximum Observed Plasma Concentration of L-dopa from Time = 0 to Time = 2 hours post dose. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.
Time frame: For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.
Tmax of L-dopa
Time to Reach the Maximum Plasma Concentration (Cmax) of L-dopa
Time frame: For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.
Mean Change From Baseline in MDS-UPDRS Score Over 2 Hours for C1, C2, C3 and Change From Baseline at 30, 60, 90, 120 Minutes for C4, in MDS-UPDRS Part III Score
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Maximum score is 132, minimum is zero. High score means worse outcome. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg treatment groups, assessment occurred at pre-dose, 15, 30, 45, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, assessment occurred at pre-dose, 30, 60, 90 and 120 minutes post-dose.
Time frame: For L-dopa 35 mg, 70 mg, 140 mg, assessment occurred at pre-dose, 15, 30, 45, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, assessment occurred at pre-dose, 30, 60, 90 and 120 minutes post-dose.
Time to Response (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Time frame: 2 hours
Cumulative Number of Responders (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Time frame: From time = 0 to 2 hours post-dose
Area Under the Curve (AUC) of Change From Baseline in MDS-UPDRS Part III Scores
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Time frame: For L-dopa 35 mg, 70 mg, 140 mg, assessments were made at pre-dose, 15, 30, 45, 60, 90, 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, assessments were made at pre-dose, 50, 60, 90, 120 minutes post-dose.
Mean Maximum Change From Baseline in MDS-UPDRS Part III Score
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total of the subscales has a maximum value of 132 and a minimum value of zero. Lower scores indicate better motor function. A negative change from baseline indicates improved motor function.
Time frame: From time = 0 to 2 hours post-dose
Subjective Time to "ON" as Evaluated by the Investigator
Investigators will evaluate subjects' fluctuations in motor functions at 15, 30, 45, 60, 90, 120, and 240 minutes post-dose to determine if they are "ON".
Time frame: 4 hours
Assessment of Time to "ON" as Evaluated by Subject Self-assessment
Subjects were asked to provide self-assessments at 15, 30, 45, 60, 90, 120, and 240 minutes post-dose as to whether they considered themselves to be "ON".
Time frame: 4 hours
AUC0-2h for Carbidopa
Area under the concentration time curve for carbidopa
Time frame: Plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose and AUC calculated from these from time 0 to 120 minutes.
Cmax of Carbidopa
Maximum concentration of carbidopa
Time frame: For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.
Tmax of Carbidopa
Time to reach the maximum concentration of carbidopa
Time frame: For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.
Duration of Response, Where Response is Defined as an Improvement of 30% in MDS-UPDRS Part III Score From Baseline.
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Maximum score is 132, minimum is zero. High score means worse outcome.
Time frame: 2 hours
Parkinson's disease patients at movement disorder clinics in Australia
| Milestone | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| Started | 8 | 6 | 6 | 6 | 6 |
| Completed | 8 | 6 | 6 | 6 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
Assessment of treatment emergent adverse events after single dosing with INP103 (L-dopa or L-dopa/carbidopa)
| Participants | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | 5 | 5 | 3 | 4 | 5 |
Area under the Plasma Concentration-time Curve for L-dopa from Time = 0 to Time = 2 hours post dose. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.
| hours*ng/mL | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|
| AUC0-2hr for L-dopa | 240.71 ± 117.819 | 463.49 ± 260.093 | 725.29 ± 456.566 | 552.75 ± 177.979 |
Maximum Observed Plasma Concentration of L-dopa from Time = 0 to Time = 2 hours post dose. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.
| ng/mL | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|
| Cmax of L-dopa | 185.80 ± 78.144 | 362.68 ± 195.265 | 643.65 ± 462.469 | 445.75 ± 183.746 |
Time to Reach the Maximum Plasma Concentration (Cmax) of L-dopa
| minutes | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|
| Tmax of L-dopa | 60.17 ± 37.950 | 66.00 ± 38.735 | 70.00 ± 15.505 | 92.00 ± 27.481 |
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Maximum score is 132, minimum is zero. High score means worse outcome. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg treatment groups, assessment occurred at pre-dose, 15, 30, 45, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, assessment occurred at pre-dose, 30, 60, 90 and 120 minutes post-dose.
| score on a scale | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| 15 minutes | -3.5 ± 3.89 | -4.5 ± 4.46 | 0.8 ± 9.20 | -9.0 ± 6.16 | NA ± NA |
| 30 minutes | -8.5 ± 6.52 | -6.7 ± 4.89 | -8.5 ± 9.09 | -12.7 ± 7.79 | -3.7 ± 3.83 |
| 45 minutes | -13.5 ± 7.09 | -4.7 ± 4.03 | -12.8 ± 11.05 | -13.7 ± 8.91 | NA ± NA |
| 60 minutes | -12.5 ± 7.87 | -6.8 ± 4.54 | -15.7 ± 9.58 | -13.5 ± 8.29 | -0.8 ± 10.63 |
| 90 minutes | -10.8 ± 9.35 | -10.3 ± 13.56 | -15.5 ± 10.03 | -9.0 ± 5.76 | -3.7 ± 10.76 |
| 120 minutes | -8.8 ± 10.61 | -11.0 ± 9.47 | -13.8 ± 11.97 | -7.2 ± 9.09 | -3.2 ± 9.22 |
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
| minutes | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| Time to Response (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline) | 45.0 (35.0 to NA) | NA (40.0 to NA) | 54.0 (15.0 to NA) | 30.0 (15.0 to NA) | NA (32.0 to NA) |
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
| Participants | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| 15 minutes | 0 | 0 | 1 | 2 | NA |
| 30 minutes | 3 | 1 | 1 | 5 | 1 |
| 45 minutes | 4 | 1 | 3 | 5 | NA |
| 60 minutes | 6 | 1 | 4 | 5 | 2 |
| 90 minutes | 6 | 2 | 5 | 5 | 3 |
| 120 minutes | 6 | 2 | 5 | 5 | 3 |
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
| change in score*minutes | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| 15 minutes | -26.25 ± 29.144 | -33.50 ± 33.697 | 7.00 ± 69.206 | -67.50 ± 46.233 | NA ± NA |
| 30 minutes | -237.63 ± 276.197 | -138.58 ± 138.105 | -50.50 ± 203.053 | -232.83 ± 153.638 | -230.08 ± 250.832 |
| 45 minutes | -264.92 ± 178.969 | -201.92 ± 162.256 | -210.50 ± 334.216 | -426.83 ± 274.566 | NA ± NA |
| 60 minutes | -573.88 ± 371.782 | -296.50 ± 241.271 | -424.25 ± 464.545 | -630.58 ± 401.947 | -295.25 ± 412.042 |
| 90 minutes | -919.75 ± 530.872 | -575.17 ± 486.241 | -896.67 ± 671.116 | -968.08 ± 587.629 | -362.75 ± 676.456 |
| 120 minutes | -1215.75 ± 765.287 | -903.67 ± 804.196 | -1324.83 ± 863.122 | -1210.58 ± 714.512 | -465.25 ± 932.842 |
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total of the subscales has a maximum value of 132 and a minimum value of zero. Lower scores indicate better motor function. A negative change from baseline indicates improved motor function.
| score on a scale | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| Mean Maximum Change From Baseline in MDS-UPDRS Part III Score | -15.5 ± 6.35 | -14.0 ± 11.15 | -20.3 ± 11.18 | -15.3 ± 8.12 | -7.5 ± 6.72 |
Investigators will evaluate subjects' fluctuations in motor functions at 15, 30, 45, 60, 90, 120, and 240 minutes post-dose to determine if they are "ON".
| minutes | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| Subjective Time to "ON" as Evaluated by the Investigator | 45.0 (30 to 240) | 240.0 (90 to NA) | 30.0 (15 to 240) | 30.0 (15 to 240) | 240.0 (30 to 240) |
Subjects were asked to provide self-assessments at 15, 30, 45, 60, 90, 120, and 240 minutes post-dose as to whether they considered themselves to be "ON".
| minutes | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| Assessment of Time to "ON" as Evaluated by Subject Self-assessment | 40.0 (15 to 240) | 240.0 (95 to NA) | 39.0 (15 to 240) | 30.0 (15 to 240) | 232.5 (31 to 240) |
Area under the concentration time curve for carbidopa
| hours*ng/mL | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|
| AUC0-2h for Carbidopa | 114.80 ± 30.384 |
Maximum concentration of carbidopa
| ng/mL | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|
| Cmax of Carbidopa | 80.23 ± 22.945 |
Time to reach the maximum concentration of carbidopa
| minutes | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|
| Tmax of Carbidopa | 44.50 ± 13.882 |
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Maximum score is 132, minimum is zero. High score means worse outcome.
| minutes | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| Duration of Response, Where Response is Defined as an Improvement of 30% in MDS-UPDRS Part III Score From Baseline. | 66.9 ± 48.35 | 23.3 ± 36.70 | 57.3 ± 42.72 | 37.5 ± 42.25 | 15.0 ± 25.10 |
Collected over 7 days. Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/8 (0%) | 0/8 (0%) | 5/8 (62.5%) |
| L-dopa 35 mg | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| L-dopa 70 mg | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| L-dopa 140 mg | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| L-dopa 70 mg/Carbidopa 7 mg | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Event | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg |
|---|---|---|---|---|---|
| headacheNervous system disorders | 0/8 | 2/6 | 0/6 | 0/6 | 0/6 |
| upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 0/8 | 1/6 | 1/6 | 1/6 | 0/6 |
| rhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/8 | 0/6 | 1/6 | 1/6 | 0/6 |
| sinus painRespiratory, thoracic and mediastinal disorders | 0/8 | 0/6 | 0/6 | 1/6 | 1/6 |
| coughRespiratory, thoracic and mediastinal disorders | 0/8 | 0/6 | 0/6 | 1/6 | 0/6 |
| dyspnoeaRespiratory, thoracic and mediastinal disorders | 0/8 | 0/6 | 0/6 | 0/6 | 1/6 |
| nasal congestionRespiratory, thoracic and mediastinal disorders | 0/8 | 0/6 | 0/6 | 0/6 | 1/6 |
| nasal drynessRespiratory, thoracic and mediastinal disorders | 0/8 | 0/6 | 0/6 | 1/6 | 0/6 |
| nasal oedemaRespiratory, thoracic and mediastinal disorders | 0/8 | 0/6 | 0/6 | 0/6 | 1/6 |
| paranasal sinus discomfortRespiratory, thoracic and mediastinal disorders | 0/8 | 0/6 | 0/6 | 0/6 | 1/6 |
| Age, Categorical(Participants) | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 3 | 1 | 3 | 5 | 18 |
| >=65 years | 2 | 3 | 5 | 3 | 1 | 14 |
| Sex: Female, Male(Participants) | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg | Total |
|---|---|---|---|---|---|---|
| Female | 3 | 2 | 2 | 2 | 3 | 12 |
| Male | 5 | 4 | 4 | 4 | 3 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 8 | 6 | 6 | 6 | 6 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 2 | 0 | 0 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 6 | 4 | 6 | 6 | 6 | 28 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | L-dopa 35 mg | L-dopa 70 mg | L-dopa 140 mg | L-dopa 70 mg/Carbidopa 7 mg | Total |
|---|---|---|---|---|---|---|
| Australia | 8 | 6 | 6 | 6 | 6 | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Jun 2019, 13 months.
Results were first posted in Aug 2020, 1 year 2 months after primary completion.
Of 96 industry-sponsored phase 2 interventional studies under Parkinson Disease, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 33. This study's 13 months is below that.
Counting every sponsor, half of 201 studies reached it within 28 months; a quarter within 16 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Levodopa
Impel Pharmaceuticals