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SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

ConditionsPARKINSON DISEASE (Disorder)Advanced Parkinson's Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorSerina Therapeutics

About this trial

This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female or male participants 40-80 years of age, inclusive, at the time of screening

Diagnosis of idiopathic Parkinson's disease consistent with UK Brain Bank and MDS Research Criteria; must include bradykinesia with sequence effect, motor asymmetry if no rest tremor, and a reliable, visible response to levodopa

On a stable regimen of anti-Parkinsonian medication for at least 4 weeks prior to Screening; MAOBIs must be stable for at least 12 weeks prior to Screening

Routine early-morning OFF, corroborated by investigator interview at Screening

Disqualifiers

Diagnosis of secondary or atypical parkinsonism

Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e., Duopa, apomorphine), surgery for PD (i.e., DBS), or anticipation of these during the study

History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia

Clinically debilitating motor complications as determined by the principal investigator or delegate (severe, disabling dyskinesias or severe OFF)

Trial design

Design model

Parallel

Treatments tested in this trial

  • SER-252 (PEOZ-apomorphine)

    Drug

    SER-252 drug product consists of 20mg lyophilized apomorphine equivalent in SER-252 drug substance in a sterile vial for reconstitution with a diluent product containing 15mM acetate buffer at pH 6.0 and 7% trehalose to maintain final pH and isotonicity in the reconstituted product.

  • enFuse

    Device

    The enFuse® device is a sterile, non-pyrogenic, user-filled, single-use, fixed-dose subcutaneous dose delivery system.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: SER-252 (PEOZ-apomorphine)Experimental treatment 2 interventions
Group B: Diluent ProductPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and Temporal Profile of Treatment-Emergent Adverse Events (TEAEs)

Proportion of participants with TEAEs (new onset or worsening) and temporal profile post-dose; TEAEs summarized by type/nature, severity/intensity, seriousness, and relationship to study treatment per protocol.

Time frame
From first dose through Day 21 (7 days after the Day 14 end-of-participation visit).
2

Incidence of Moderate or Severe TEAEs Related to Study Intervention

Proportion of participants experiencing moderate or severe TEAEs related to study intervention (including possibly and probably related).

Time frame
From first dose through Day 21 (7 days after the Day 14 end-of-participation visit).
3

Incidence of Serious Adverse Events (SAEs), including suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)

Proportion of participants with SAEs (ICH-GCP), including suicidality identified via C-SSRS

Time frame
From first dose through Day 44 (30 days after the Day 14 end-of-participation visit).
4

Change from Baseline in Vital Signs

Mean change from baseline in systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.

Time frame
Baseline to Day 8 (with Day 14 follow-up vitals also collected)

Secondary outcomes

Other outcomes

1

Exploratory Efficacy Endpoint: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II

MDS-UPDRS Part II Change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score. The MDS-UPDRS Part II assesses motor aspects of daily living on a scale from 0 to 52, with higher scores indicating greater impairment.

Time frame
Change from Baseline at Day 8
2

Exploratory Efficacy Endpoint: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - Change from Baseline at 4 Hours

Change from baseline in the MDS-UPDRS Part III (motor examination) total score at 4 hours post-dose. The MDS-UPDRS Part III ranges from 0 to 132, with higher scores indicating greater motor impairment. Time Frame: Baseline to 4 hours post-dose.

Time frame
Baseline to 4 hours post dose
3

Exploratory Efficacy Endpoint: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - Maximum Daily Change from Baseline

Maximum (most extreme) change from baseline in MDS-UPDRS Part III total score observed across the following post-dose timepoints: 1, 2, 3, 4, 6, 9, and 12 hours. Scale range: 0-132, higher scores = worse.

Time frame
Baseline to 12 hours post-dose
4

Exploratory Efficacy Endpoint: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - Area Under the Curve (AUC)

AUC of change from baseline in MDS-UPDRS Part III total score over the following timepoints: baseline and 1, 2, 3, 4, 6, 9, and 12 hours post-dose. Positive AUC values indicate net worsening; negative values indicate net improvement over time. Scale range: 0-132, higher scores = worse. Time Frame: Baseline to 12 hours post-dose.

Time frame
Baseline to 12 hours post-dose

Sponsors and contacts

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Serina Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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