AzTrials
AzTrials

Parkinson DiseasePhase 1NCT03665454

PF 06412562 in Subjects With Advanced Stage Parkinson's Disease

A Phase 1 study testing PF-06412562 in people with Parkinson Disease, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to test the safety and tolerability of the investigational drug PF-06412562 compared to the current medical standard of care medication for Parkinson's disease, carbidopa/levodopa. Read more about this study

Who is it for?
Any age
Conditions the study is for
Parkinson Disease
What is being tested?
PF-06412562
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
1 siteUnited States
Study dates
24 Sep 2018to 21 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of classic PD with history of clinically meaningful response to levodopa
  • Disease duration >15 years since diagnosis
  • Hoehn \& Yahr stage >IV "on" or "off" levodopa
  • Consent signed by subject, if possible
  • If subject is cognitively impaired, consent signed by power of attorney or legally authorized subject representative
  • Assent from the study subject, if possible
  • Stable dose of all medications for 60 days prior to Day 1 of first week of study

Who cannot join

  • Atypical parkinsonian syndrome (e.g., never responded to levodopa, and/or atypical signs)
  • Acute or unstable medical condition such as heart disease, kidney and liver failure
  • History of HIV, hepatitis B and C
  • Use of moderate to strong CYP 3A4 modulators (see both inhibitors and inducers in Appendix BB)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: A Phase Ib Safety, Tolerability, and Efficacy Study of Two Days of Oral Split Dose (25/20 mg) Administration of PF 06412562 in Subjects With Advanced Stage Parkinson's Disease

The purpose of this study is to test the safety and tolerability of the investigational drug PF-06412562 compared to the current medical standard of care medication for Parkinson's disease, carbidopa/levodopa. This research also is being done to find out if the investigational drug PF-06412562 can help improve the motor (movement) function, alertness, and cognitive (thinking) skills of people who are considered to be in the advanced-stage of Parkinson's disease. In this study, PF06412562 is 'investigational,' which means that it is experimental and has not been approved by the US Food and Drug Administration (FDA), but can be used in clinical research studies such as this one.

Read the detailed description

The investigators are conducting a randomized, double-blind, carbidopa/levodopa-controlled crossover safety, tolerability, and efficacy study of the investigational compound, PF-06412562, in advanced Parkinson's patients. The primary purpose of this study is to test the safety and tolerability of the investigational drug PF-06412562 compared to the current medical standard of care medication for Parkinson's disease, carbidopa/levodopa, in these patients. This secondary purpose of this research is to find out if the investigational drug PF-06412562 can help improve the motor (movement) function, alertness, and cognitive (thinking) skills of people who are considered to be in the advanced-stage of Parkinson's disease. This study will inform the field as to whether PF-06412562 is safe and well-tolerated in advanced Parkinson's patients, and also may provide preliminary data on its efficacy in several domains.

Being tested
PF-06412562, Standard of Care Placebo
Keywords
Parkinson's Disease, Parkinson Disease, End-Stage, Progressed, Advanced Parkinson's Disease, End-Stage Parkinson's Disease, Clinical intervention, Double-blind, randomized
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06412562Drug

    PF-06412562 is a dopamine agonist developed by Pfizer Inc. into a tablet form for oral usage. It will be provided as 5 mg tablets. Thus, to administer the 25 mg dose, 5 x 5 mg tablets will be given; and to administer the 20 mg dose, 4 x 5 mg tablets will be administered.

  • Standard of Care PlaceboDrug

    Also called Sinemet

    25/100 mg tablet(s) of carbidopa/levodopa will be encapsulated and administered according to the subject's home regimen.

Study groups in NCT03665454
Study groupRoleWhat they receive
PF-06412562ExperimentalSubjects will receive 25 mg of PF-06412562 twice daily on study Days 2 and 3, along with placebo carbidopa/levodopa dosed at these times. Additional carbidopa/levodopa placebo capsules also will be administered according to the subject's home regimen.
Receives: Drug: PF-06412562
Standard of Care carbidopa/levodopaActive comparatorSubjects will take placebo tablets for the PF-06412562 twice daily on study Days 2 and 3, along with active carbidopa/levodopa (25/100 mg) administered at these times. Additional active carbidopa/levodopa capsules also will be administered according to the subject's home regimen.
Receives: Drug: Standard of Care Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of PF-06412562 assessed by blood sample results

    NA (mmol/L), K(mmol/L), HCO3(mmol/L)

    Measured: Day 1

  2. Safety and tolerability of PF-06412562 assessed by blood sample results

    Ca (mg/dL), Mg (mg/dL), BUN( mg/dL), Creatinine (mg/dL), Bilirubin (mg/dL)

    Measured: Day 1

  3. Safety and tolerability of PF-06412562 assessed by blood sample results

    AST (U/L), ALT (U/L)

    Measured: Day 1

  4. Safety and tolerability of PF-06412562 assessed by blood sample results

    white blood cell count (K/uL), platelets (K/uL)

    Measured: Day 1

  5. Safety and tolerability of PF-06412562 assessed by blood sample results

    Hematocrit (%)

    Measured: Day 1

  6. Safety and tolerability of PF-06412562 assessed by blood sample results

    hemoglobin (g/dL)

    Measured: Day 1

  7. Safety and tolerability of PF-06412562 assessed by blood sample results

    NA (mmol/L), K(mmol/L), HCO3(mmol/L)

    Measured: Day 4

  8. Safety and tolerability of PF-06412562 assessed by blood sample results

    Ca (mg/dL), Mg (mg/dL), BUN (mg/dL), creatinine (mg/dL), bilirubin (mg/dL)

    Measured: Day 4

  9. Safety and tolerability of PF-06412562 assessed by blood sample results

    AST (U/L), ALT (U/L)

    Measured: Day 4

  10. Safety and tolerability of PF-06412562 assessed by blood sample results

    white blood cell count (K/uL), platelets (K/uL)

    Measured: Day 4

  11. Safety and tolerability of PF-06412562 assessed by blood sample results

    hematocrit (%)

    Measured: Day 4

  12. Safety and tolerability of PF-06412562 assessed by blood sample results

    hemoglobin (g/dL)

    Measured: Day 4

  13. Safety and tolerability of PF-06412562 assessed by blood sample results

    Red blood cell count (M/uL)

    Measured: Day 4

  14. Safety and tolerability of PF-06412562 assessed by vital signs

    height (inches)

    Measured: Time Frame: Vital signs: X2 on Day 1

  15. Safety and tolerability of PF-06412562 assessed by vital signs

    weight (lbs)

    Measured: X2 on Day 1

  16. Safety and tolerability of PF-06412562 assessed by vital signs

    blood pressure (mmHg)

    Measured: X2 on Day 1

  17. Safety and tolerability of PF-06412562 assessed by vital signs

    heart rate (bpm)

    Measured: X2 on Day 1

  18. Safety and tolerability of PF-06412562 assessed by vital signs

    respiratory rate (breathes/min)

    Measured: X2 on Day 1

  19. Safety and tolerability of PF-06412562 assessed by vital signs

    temperature (F)

    Measured: X2 on Day 1

  20. Safety and tolerability of PF-06412562 assessed by vital signs

    height (inches)

    Measured: X3 on Days 2

  21. Safety and tolerability of PF-06412562 assessed by vital signs

    blood pressure (mmHg)

    Measured: X3 on Days 2

  22. Safety and tolerability of PF-06412562 assessed by vital signs

    heart rate (bpm)

    Measured: X3 on Days 2

  23. Safety and tolerability of PF-06412562 assessed by vital signs

    respiratory rate (breathes/min)

    Measured: X3 on Days 2

  24. Safety and tolerability of PF-06412562 assessed by vital signs

    temperature (F)

    Measured: X3 on Days 2

  25. Safety and tolerability of PF-06412562 assessed by vital signs

    height (inches)

    Measured: X3 on Days 3

  26. Safety and tolerability of PF-06412562 assessed by vital signs

    weight (lbs)

    Measured: X3 on Days 3

  27. Safety and tolerability of PF-06412562 assessed by vital signs

    blood pressure (mmHg)

    Measured: X3 on Days 3

  28. Safety and tolerability of PF-06412562 assessed by vital signs

    heart rate (bpm)

    Measured: X3 on Days 3

  29. Safety and tolerability of PF-06412562 assessed by vital signs

    respiratory rate (breathes/min)

    Measured: X3 on Days 3

  30. Safety and tolerability of PF-06412562 assessed by vital signs

    temperature (F)

    Measured: X3 on Days 3

  31. Safety and tolerability of PF-06412562 assessed by vital signs

    height (inches)

    Measured: X2 on Day 4

  32. Safety and tolerability of PF-06412562 assessed by vital signs

    weight (lbs)

    Measured: X2 on Day 4

  33. Safety and tolerability of PF-06412562 assessed by vital signs

    blood pressure (mmHg)

    Measured: X2 on Day 4

  34. Safety and tolerability of PF-06412562 assessed by vital signs

    heart rate (bpm)

    Measured: X2 on Day 4

  35. Safety and tolerability of PF-06412562 assessed by vital signs

    respiratory rate (breathes/min)

    Measured: X2 on Day 4

  36. Safety and tolerability of PF-06412562 assessed by vital signs

    temperature (F)

    Measured: X2 on Day 4

  37. Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function

    Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)

    Measured: X1 on Day 1 over 15 min

  38. Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function

    heart rate (beats/min), sinus arrhythmia (beats/min)

    Measured: X1 on Day 1 over 15 min

  39. Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function

    Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)

    Measured: X3 on Days 2 over 15 min each time

  40. Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function

    heart rate (beats/min), sinus arrhythmia (beats/min)

    Measured: X3 on Days 2 over 15 min each time

  41. Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function

    Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)

    Measured: X3 on Days 3 over 15 min each time

  42. Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function

    heart rate (beats/min), sinus arrhythmia (beats/min)

    Measured: X3 on Days 3 over 15 min each time

  43. Safety and tolerability of PF-06412562 assessed by UPDRS-IV

    UPDRS-IV (United Parkinson's Disease Rating Scale): each questions scored on scale of 0 to 4, where 0= not present, 4= severe; subscales are summed to yield a total score, min total score:0, max total score:81; higher score corresponds to increased disease severity

    Measured: X3 on Days 2

  44. Safety and tolerability of PF-06412562 assessed by UPDRS-IV

    UPDRS-IV (United Parkinson's Disease Rating Scale): each questions scored on scale of 0 to 4, where 0= not present, 4= severe; subscales are summed to yield a total score, min total score:0, max total score:81; higher score corresponds to increased disease severity

    Measured: X3 on Days 3

  45. Safety and tolerability of PF-06412562 assessed by Columbia Suicide Rating

    C-SSRS measures suicidal ideation and/or behavior. Rated from Category 1-10 with Category 1 being the least severe, and Category 10 representing the most severe, i.e. completing suicide.

    Measured: X1 on Day 1

  46. Safety and tolerability of PF-06412562 assessed by Columbia Suicide Rating

    C-SSRS measures suicidal ideation and/or behavior. Rated from Category 1-10 with Category 1 being the least severe, and Category 10 representing the most severe, i.e. completing suicide.

    Measured: X1 on Day 4

Secondary outcomes (1)

  1. Pilot data on potential efficacy of PF-06412562 compared to the standard of care treatment (i.e., carbidopa/levodopa) on overall signs and quality of life in subjects with advanced PD

    • Clinician Global Impression of Change score: measures change in disease symptoms per clinician's judgement. Each item rated 1-7, 1=marked improvement, 7= marked worsening; min Caregiver perception of change interview: interviews with participants' caregiver(s). Open-ended questions elicit open-ended answers about subject's behavior, appearance, cognition, etc. over the study

    Measured: Global Impression of Change: X3 on Days 2 and 3; Caregiver Perception of Change: X1 on Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2018
  2. Study start24 Sep 2018
  3. Primary completion21 Mar 2019
  4. Study completion21 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Subjects will participate in study for 2 consecutive weeks. Days 2-3 of Week 1, they will be blindly and randomly assigned to one of two treatment arms (study drug PF-06412562 or standard of care carbidopa/levodopa). Whichever treatment arm they did not receive during Week 1, they will receive during Days 2-3 of Week 2.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03665454
Sponsor's protocol ID
9437
Status last verified
Jul 2019
First submitted
1 Aug 2018
Last updated
31 Jul 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fernandez-Mendoza J, Puzino K, Amatrudo G, Bourchtein E, Calhoun SL, Plante DT, Kaplan K. The Hypersomnia Severity Index: reliability, construct, and criterion validity in a clinical sample of patients with sleep disorders. J Clin Sleep Med. 2021 Nov 1;17(11):2249-2256. doi: 10.5664/jcsm.9426.

    PubMed 34032202

  • Huang X, Lewis MM, Van Scoy LJ, De Jesus S, Eslinger PJ, Arnold AC, Miller AJ, Fernandez-Mendoza J, Snyder B, Harrington W, Kong L, Wang X, Sun D, Delnomdedieu M, Duvvuri S, Mahoney SE, Gray DL, Mailman RB. The D1/D5 Dopamine Partial Agonist PF-06412562 in Advanced-Stage Parkinson's Disease: A Feasibility Study. J Parkinsons Dis. 2020;10(4):1515-1527. doi: 10.3233/JPD-202188.

    PubMed 32986682

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06412562 in people with Parkinson Disease, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of PF-06412562 assessed by blood sample results (time frame: Day 1). The study lists 46 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03665454, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in