A Study of Buntanetap in Participants With PD
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age40-85
SponsorAnnovis Bio Inc.
About this trial
This study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study. This study will be conducted with two cohorts. Cohort 1 will enroll via invitation only for PD participants who have previously participated in buntanetap clinical trials. Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. Qualified participants will receive buntanetap 30mg QD after a screening period of up to 42 days.
Eligibility criteria
Qualifiers
Diagnosis of idiopathic PD according to MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015) and
Have a support person who will accompany the participant on study visits at designated times.
Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation,
Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation,
Disqualifiers
Cohort 1 only: Is currently receiving DBS treatment. (Participant may enroll in Cohort 2 if they meet the corresponding inclusion/exclusion criteria).
A history of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), unless their symptoms have been mild, and they are stable on treatment or no longer need treatment. Mild depression or history of depression that is stable on treatment with selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) medication at a stable dose is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications.
A history of seizure disorder. If stable on medication, it is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications.
A history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 450 ms for men and ≥ 460 ms for women, or torsades de pointes.
Trial design
Treatments tested in this trial
- buntanetap/posiphen
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Annovis Bio Inc.
Lead sponsor
Duke Clinical Research Institute
Collaborator
Source ClinicalTrials.gov