NovusClarus
50 mg MDMA + 500 mg acetaminophen
Clinical-development framework
Trial Development
From hypothesis to human trials through explicit endpoints, safety architecture, and regulatory gates.
NovusClarus
Proposed four-arm component study.
The trial architecture is designed to answer whether the fixed combination contributes benefit beyond either component alone and placebo.
MDMA
50 mg
Acetaminophen
500 mg
Placebo
Matched comparator
Endpoint hierarchy
Predefined before enrollment.
Primary, secondary, exploratory, and safety endpoints are separated to reduce narrative flexibility after results are known.
Sensory symptom change
Standardized patient-reported measure plus sensory mapping or quantitative testing.
Fine motor function
Nine-Hole Peg Test, typing or dexterity tasks, and daily functional performance.
Quality of life
MSQOL-54, fatigue, cognition, pain interference, and participant-prioritized outcomes.
Neuroplasticity
Imaging, biomarkers, sensory-network measures, or mechanistic substudies if justified.
Development gates
Sequence before speed.
Dates are not presented until partners, regulatory strategy, manufacturing feasibility, and required studies are established.
Source Audit
Verify case records, timelines, dose context, and adverse events.
Scientific Review
External critique of indication, mechanism, confounders, and formulation.
CMC & Nonclinical
Manufacturing, analytical, stability, interaction, and safety strategy.
Pre-IND
FDA consultation on development plan and evidence requirements.
Phase 1
Safety, tolerability, PK, monitoring, and dosing feasibility.
Phase 2
Randomized proof of concept and component contribution.
Decision
Proceed, redesign, partner, license, pause, or discontinue.
Belcopa
Behavioral-intervention pathway.
Belcopa requires a separate protocol-development program focused on practitioner behavior, informed disclosure, context, debriefing, and ethically valid comparison conditions.
Ethics
Protocol
Fidelity
Pilot
Controlled
Replicate