A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)

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Brief Title

A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)

Official Title

A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)

Brief Summary

      This is a Phase 2a study to assess the safety and tolerability of TPN-101 patients with PSP.
    

Detailed Description

      This is a Phase 2a multi-center, randomized, double-blind, placebo-controlled parallel-group,
      4-arm study with an open-label treatment phase in patients with PSP. This study includes a
      6-week Screening Period, a 24-week Double-blind Treatment Period, a 24-week Open label
      Treatment Period, and a Follow-up Visit 4 weeks post treatment.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Assess the safety and tolerability of TPN-101 in patients with progressive supranuclear palsy (PSP)

Secondary Outcome

 Assess the pharmacokinetics of TPN-101 as measured by concentrations of TPN-101 in plasma and cerebrospinal fluid (CSF)

Condition

Progressive Supranuclear Palsy

Intervention

TPN-101, 100 mg/day

Study Arms / Comparison Groups

 TPN-101, Dose A
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

October 15, 2021

Completion Date

July 15, 2023

Primary Completion Date

July 15, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Clinical diagnosis of probable progressive supranuclear palsy (PSP)

          2. Presence of PSP symptoms for less than 5 years

          3. Body weight range of ≥ 41 kg (90 lbs) to ≤ 118 kg (260 lbs)

          4. Has a reliable caregiver to accompany the patient to all study visits.

          5. Score ≥ 18 on the Mini Mental State Exam (MMSE) at Screening

          6. Patient must reside outside a skilled nursing facility or dementia care facility at
             the time of Screening, and admission to such a facility must not be planned. Residence
             in an assisted living facility is allowed

          7. If patient is receiving coenzyme Q10, levodopa/carbidopa, levodopa/ benserazide, a
             dopamine agonist, catechol-o-methyltransferase inhibitor, other Parkinson's disease
             medication, or memantine with or without acetylcholinesterase inhibitors for
             cognition, the dose must have been stable for at least 30 days prior to Screening and
             must remain stable for the duration of the study. No such medication may be initiated
             during the study

        Exclusion Criteria:

        Patients must not meet any of the following criteria:

          1. Presence of other significant neurological or psychiatric disorders including (but not
             limited to) Alzheimer's disease; dementia with Lewy bodies; prion disease; Parkinson's
             disease (which has not subsequently been revised to PSP); amyotrophic lateral
             sclerosis or other motor neuron disease; multiple sclerosis; any psychotic disorder;
             severe bipolar or unipolar depression; prior history of a suicide attempt or current
             suicidal thoughts or behavior that are believed to represent a safety risk as
             indicated by a "yes" response to Question 2 of the C-SSRS; seizure; brain tumor or
             other space-occupying lesion; history of stroke; or history of severe head injury
             within the past 20 years

          2. History of significant brain abnormality, including, but not limited to, prior
             hemorrhage or infarct, cerebral contusion, encephalomalacia, aneurysm, vascular
             malformation, subdural hematoma (SDH), hydrocephalus, or space-occupying lesion (e.g.,
             abscess or brain tumor such as meningioma). If there is history or evidence on
             neurologic exam suggesting possible SDH, patients should be fully evaluated, including
             MRI if indicated, to exclude significant, new SDH

          3. Presence of cerebellar ataxia, choreoathetosis, early symptomatic autonomic
             dysfunction, or moderate to severe resting tremor, responsive to levodopa

          4. Known history of serum or plasma progranulin level less than one standard deviation
             below the normal patient mean for the laboratory performing the assay
      

Gender

All

Ages

41 Years - 86 Years

Accepts Healthy Volunteers

No

Contacts

, 310-261-5312, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04993768

Organization ID

TPN-101-PSP-201


Responsible Party

Sponsor

Study Sponsor

Transposon Therapeutics, Inc.


Study Sponsor

, , 


Verification Date

October 2021