NCT06830642

Study of the Oral Treatment MTR-601 in Cervical Dystonia

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of MTR-601, a Novel Oral Treatment in Patients With Cervical Dystonia

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Motric Bio · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Study MTR-601-201 is an 8-week, randomized, placebo-controlled study to examine the safety, tolerability, and efficacy of MTR-601 in participants with cervical dystonia.

Detailed description

Study MTR-601-201 is an 8-week, randomized, placebo-controlled study to examine the safety, tolerability, and efficacy of MTR-601 in participants with cervical dystonia. Participants will be randomized (1:1) to receive either MTR-601 or matching placebo every day for 4 weeks, after which all participants will be followed for an additional 2 weeks through study treatment washout. The Investigator and Participant will be blinded to the assigned arm. Treatment will be administered via capsules and matching placebo capsules. The total sample size will be approximately 80 participants. The study will be divided into 3 periods: Screening, Treatment and Follow up. An initial screening assessment (V1) will occur between Day -90 and Day -2, where individuals will undergo informed consent and have their preliminary eligibility reviewed. Individuals who are found to be eligible will be instructed to not receive their next scheduled botulinum toxin treatment prior to entry into the study. A full Screening visit (V2) will occur between Day -14 and -1. Individuals who are confirmed to be eligible after V2, including having not received botulinum toxin treatment for ≥3 months (≥6 months for daxibotulinum ToxinA), will return to clinic on Day 1 for randomization and initiation of study treatment (V3). At this visit individuals will be randomized into the study and receive either MTR-601 or matching placebo to take for the duration of the study and will be discharged home. Individuals will take the first dose and subsequent doses of study treatment once daily while at home, with weekly visits during the treatment period to assess safety, tolerability and efficacy. At Day 36 and thereafter, participants may resume treatment with botulinum toxin or daxibotulinum toxinA. Individuals will return to the clinic 14 days after completion of treatment (Day 42) for the end of study visit (V8) where final safety assessments will be performed. Individuals will then be discontinued from the study.

Conditions

• Cervical Dystonia

Interventions

Type	Name	Description
DRUG	MTR-601	Capsule
DRUG	Placebo	Capsule

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-07-08
• Completion: 2026-08-03
• First posted: 2025-02-17
• Last updated: 2025-12-12

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study