BetterLife Pharma in partnership with
A trial observation brief for BetterLife Pharma

Cluster headache data deserves observation that doesn't end at the diary entry.

BETR-001's cluster headache program faces a measurement gap most CNS trials carry: the distance between patient-reported attack frequency and what's clinically happening between attacks. Videra Health captures the high-resolution behavioral data that makes the efficacy case to FDA and the value case to payers.

See how we'd observe BETR-001

The Asset

BETR-001 (BOL-148)

BetterLife's BOL-148 program for cluster headache — non-hallucinogenic 5-HT2A modulation in a high-need, underserved patient population.

IndicationCluster Headache
PhasePhase 2
Mechanism5-HT2A modulator (BOL-148)
DifferentiatorNon-hallucinogenic
PopulationHigh-need, underserved
Outcome priorityAttack frequency + inter-attack burden
Why we're paying attention

Cluster headache is a measurement problem hiding in plain sight.

BOL-148 for cluster headache

BETR-001 is BetterLife's BOL-148 program targeting cluster headache — one of the most painful conditions in medicine, with limited approved treatment options and a small but high-need patient population.

The 5-HT2A mechanism without psychedelic effects is the commercial story. The measurement question — how do you prove efficacy in attacks that come in clusters and disappear in remission — is the trial design story.

Beyond the attack diary

Most cluster headache trials rely on patient-reported attack frequency. That data captures the events, but not the inter-attack burden, the anticipatory distress, the recovery patterns. Continuous voice and video monitoring across attack and remission periods generates the high-resolution data that makes the case to both FDA and payers.

The cluster headache market is small but high-need. Well-validated outcomes data is the difference between a niche launch and a foundational franchise.

Cluster
High-need indication with limited current options
BOL-148
Decades of pharmacology research on the parent compound
Non-H
Non-hallucinogenic 5-HT2A modulator
In the News

We've tracked BETR-001 through Phase 2 development.

BetterLife Pharma's non-hallucinogenic 5-HT2A program for cluster headache.

The observation problem

Attack diaries miss most of what matters.

Four observation gaps separate 'fewer attacks' from a foundational cluster headache franchise.

Gap 1: Inter-Attack Burden

Attacks come in clusters. So does the suffering.

Patient-reported attack frequency captures the events but not the anticipatory anxiety, the sleep disruption, the functional impairment. Continuous behavioral monitoring across attack and remission periods captures all of it.

Gap 2: Objective Severity

Attack severity is subjective. Voice patterns are not.

Vocal stress markers, facial pain expression, and linguistic content during and after attacks generate the objective severity data that strengthens efficacy claims and payer access conversations.

Gap 3: Recovery Trajectories

How fast a patient recovers between attacks is part of the story.

BETR-001's value proposition includes faster between-attack recovery. Continuous behavioral capture surfaces that recovery curve in trial data and post-launch evidence.

Gap 4: Payer Differentiation

A small market needs unambiguous data.

Cluster headache is a high-need but small market. The difference between 'covered' and 'not covered' often comes down to data depth. Videra delivers it.

Three ways Videra observes BETR-001

Purpose-built for cluster headache evidence generation.

Our platform pairs in-clinic AI hardware with multimodal behavioral analytics and a custom algorithm engine, already proven in TDScreen and Check on Mom. Here's how each maps to BETR-001.

01 · Ambient Monitoring

An AI-powered video cart that captures Phase 2 cluster headache trial sessions.

A clinical-grade camera and directional audio rig that drops into any BETR-001 site in minutes. Every patient assessment captured consistently — the baseline for objective attack severity and recovery measurement.

  • Verifies dosing protocol adherence and consistent administration across sites
  • Standardizes facilitator language and post-dose check-ins
  • Generates a defensible session record for regulators, monitors, and post-hoc review
  • HIPAA-compliant, end-to-end encrypted; data never leaves the secure pipeline
See it in action. Videra Monitoring Stand reference →
PROTOCOL: VERIFIED Site #042 · Session 14 VIDERA MONITORING STAND Same setup. Same angles. Every site. Every session.
VoiceVitals · Live capture● Recording
00:00T+18 min00:60
Vocal affect tone↑ 32% vs. baseline
Speech rate variabilityNormalized at T+45
Facial expressivity (FACS)Peak T+22 min
Linguistic sentiment+1.8σ shift sustained
02 · Multimodal AI Endpoints

ASSESS extends observation beyond the clinic into daily life.

Multimodal analysis of voice, video, and language across attacks and remission periods, captured remotely between clinic visits. The data depth a small but high-need market requires.

  • Objectively capture onset, peak, and resolution of the psychoactive window
  • Augment MADRS and HAM-D with continuous, between-visit behavioral data
  • Built on 1M+ patient interactions across 300+ behavioral health facilities
  • Designed for 21 CFR Part 11, HIPAA, and SOC 2 Type II environments
Proof point: Check on Mom. Live AI video screener for postpartum depression →
03 · Custom Algorithms

Custom biomarkers for cluster headache efficacy.

For BETR-001, that means a proprietary attack severity and inter-attack burden index — capturing the full disease burden that drives both regulatory approval and payer access.

  • Capture attack severity, inter-attack burden, and recovery trajectory objectively
  • Stratify likely responders vs. non-responders earlier in treatment
  • Feed regulatory submissions, label expansion, and payer dossiers
  • Live algorithms today: TDScreen (AUC 0.89, J Clin Psychiatry) and Check on Mom
Proof point: TDScreen. AI that outperforms trained clinician raters, in production →
LIVE · IN MARKET

TDScreen

AI-powered tardive dyskinesia screening built on the AIMS standard. AUC 0.89 vs. trained raters, peer-reviewed in J Clin Psychiatry.

tdscreen.ai →

LIVE · IN MARKET

Check on Mom

Conversational AI + video screener for postpartum depression. Used in real homes, on real devices, validated against clinical frameworks.

checkonmom.ai →

PROPOSED · BETR-001

A "BETR-001 Cluster Headache Index"

Multimodal AI model trained on BETR-001 Phase 2 data, capturing attack severity, recovery trajectory, and inter-attack burden in a way attack diaries cannot.

Strategic Alignment

Where BetterLife Pharma is headed, and how Videra fits.

Your BETR-001 development strategy, mapped to Videra capabilities in production.

BetterLife Pharma's Priority
How Videra Accelerates
Generate FDA-defensible cluster headache outcomes data
ePRO+ with VoiceVitals captures attack frequency, severity, and inter-attack signal
Document non-hallucinogenic profile objectively
Behavioral capture isolates the 5-HT2A mechanism from subjective effects
Build payer-grade evidence for a small market
Behavioral-health network depth supports niche-indication value cases
Position BETR-001 against current cluster headache options
Comparison-grade behavioral data anchors the differentiation story
Build launch infrastructure for a high-need population
EngageEntry for cluster headache patient identification, SignalSort for adherence
Built on real-world data

Not a pitch. A platform.

Videra's network isn't our customer base. It's the living dataset that powers every algorithm we build. For BetterLife Pharma, that means real clinical depth and peer-reviewed validation.

300+
Behavioral health facilities
1M+
Patient interactions analyzed
0.89
AUC for TDScreen (J Clin Psychiatry, 2025)
94%
Patient program completion rate
HIPAA Compliant SOC 2 Type II 21 CFR Part 11 ready End-to-End Encrypted

Let's explore what this could look like for BETR-001.

We'd welcome a 30-minute session to walk BetterLife Pharma through a tailored, protocol-by-protocol proposal for BETR-001's cluster headache program.

Your Videra contact
Ryan Roberts
Videra Health
ryan@viderahealth.com viderahealth.com →