Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

December 15, 2026

Study Completion Date

June 30, 2027

Conditions
Chemotherapy-induced Peripheral NeuropathyDrug-Induced Nephropathy
Interventions
DRUG

VMD-3866 Gel

"Each participant will have 2 treatment periods, separated by a washout of at least 7 days. Participants will be randomized 1:1 to receive VMD-3866 gel in one period, and placebo gel in the other. Before the start of each treatment period, participants will have a Run-in period lasting 7 days, during which they will record NPRS scores each morning in a trial diary. Participants will continue to record NPRS scores in the trial diary during treatment periods 1 and 2 (about 1 h after each dose).~Participants will be screened within 45 days before their first treatment period. Eligible participants may attend an outpatient visit up to 14 days before their first dose of VMD-3866 or placebo, for baseline QST and, in ≥ 8 participants, a skin biopsy. Participants will visit the site for their first and last doses (Days 1 and 8) in each treatment period. All other doses they will self-administer at home."

DRUG

Placebo Gel

Each participant will have 2 treatment periods, separated by a washout of at least 7 days. Participants will be randomized 1:1 to receive VMD-3866 gel in one period, and placebo gel in the other. Before the start of each treatment period, participants will have a Run-in period lasting 7 days, during which they will record NPRS scores each morning in a trial diary. Participants will continue to record NPRS scores in the trial diary during treatment periods 1 and 2 (about 1 h after each dose). Participants will be screened within 45 days before their first treatment period. Eligible participants may attend an outpatient visit up to 14 days before their first dose of VMD-3866 or placebo, for baseline QST and, in ≥ 8 participants, a skin biopsy. Participants will visit the site for their first and last doses (Days 1 and 8) in each treatment period. All other doses they will self-administer at home.

Trial Locations (1)

NW10 7EW

RECRUITING

Hammersmith Medicines Research Ltd (HMR code 24-503), London

All Listed Sponsors
lead

VM Therapeutics LLC

INDUSTRY

NCT07072468 - Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy | Biotech Hunter | Biotech Hunter