Clinical Enroll

4 Patients Randomized. $2,500 Per Randomized Patient.

A Vertex study site enrolled 4 patients into a Phase 3 diabetic peripheral neuropathy study across two site locations, under a randomization commitment. Screening is ongoing.

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4

Patients Randomized

$10,000

Campaign Investment

$2,500

Cost Per Randomized Patient

Sponsor

Vertex Pharmaceuticals Incorporated

Drug

Suzetrigine (SUZ)

Phase

3

Condition

Diabetic Peripheral Neuropathic Pain

Key eligibility

Age 18 to 80, body weight 45 kg or more, BMI 18 to under 40, type 1 or type 2 diabetes with HbA1c 9% or lower, bilateral lower-extremity DPN pain for at least 1 year, weekly average daily NPRS score of 4 to 9 with limited variation across a 7-day baseline period

Site profile

2 site locations (multi-site engagement)

Registration

NCT07231419 on ClinicalTrials.gov

A Common Condition With an Uncommon Screening Runway

A Vertex study site was running a Phase 3 trial of suzetrigine for pain associated with diabetic peripheral neuropathy, a 734-participant study spread across more than 60 US sites. Diabetic nerve pain is common and self-identifiable, so the top of the funnel was never the constraint.

The constraint sat further down. Eligibility turned on a 7-day baseline pain diary: a candidate had to log a daily pain score in a narrow band, with limited variation and no more than 3 missing entries, before a randomization decision could even be made. Layered on top were a BMI ceiling, an HbA1c limit, and a requirement for bilateral lower-extremity pain lasting at least a year.

That structure puts a fixed waiting period between a qualified referral and a randomized patient. It is a protocol design reality rather than a site performance issue, and it is the kind of thing that separates a lead count from an enrollment result. The site needed referrals pre-screened against the full criteria set and a partner accountable for randomizations rather than volume.

Feasibility Confirmed. Commitment Extended. Campaign Deployed.

Clinical Enroll evaluated the DPN protocol for feasibility before any campaign work began, modeling the addressable patient population, the cumulative effect of the eligibility criteria, and per-site enrollment targets at both locations. The commitment was confirmed supportable and formalized in contract. An IRB-compliant campaign was built and deployed across symptom-targeted digital channels, with a pre-screening questionnaire aligned to the study's inclusion and exclusion criteria. Candidates who did not meet the DPN-specific threshold were not referred, and those who did were carried through the baseline diary window rather than handed off at the point of interest.

4 Randomized Patients. Two Site Locations. Screening Ongoing.

The campaign delivered 4 randomized patients across two site locations against a combined $10,000 investment, a cost per randomized patient of $2,500.

The study is still recruiting and screening activity continues at both locations. The figures above are randomizations confirmed by the site to date against the investment already spent, not a closed-out final total.

Per-patient site fees for Phase 3 studies typically range from $8,000 to $20,000 per randomized patient depending on indication and protocol complexity. At an estimated $8,000 to $20,000 per-patient site fee, 4 randomized patients represents a potential $32,000 to $80,000 in patient revenue against a $10,000 campaign investment.

POTENTIAL ROI

$10,000

Campaign investment

$8k–$20k

Per-patient site fee range

$32k–$80k

Potential patient revenue

How Feasibility Was Verified Before Launch

Clinical Enroll evaluated the suzetrigine DPN protocol for feasibility across both site locations before extending a randomization commitment. Because the binding constraint was the baseline diary window rather than the size of the patient pool, the review modeled how many qualified candidates would clear the full criteria set, not just how many would respond to an ad.

  1. Protocol and eligibility review. Study criteria verified against the registered protocol, NCT07231419.
  2. Addressable population modeling. Diabetes prevalence, neuropathy pain severity, and BMI and HbA1c thresholds assessed within each site's catchment area.
  3. IRB-ready campaign build. Symptom-targeted creative and channels developed for compliance review at each site.
  4. Pre-screening. Every referral is screened against the study's inclusion and exclusion criteria before reaching a site.
  5. Contracted randomization commitment. Per-site enrollment targets are fixed in writing before the campaign launches.

Read more about how Clinical Enroll runs feasibility assessments before every engagement.

Common questions about this engagement.

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All campaigns developed for IRB review and deployed in accordance with FDA guidance on clinical trial advertising.