Study of the Oral Treatment MTR-601 in Cervical Dystonia

NCT06830642 | Suspended Phase 2 DMC FDA Drug

• 1 other identifier: MTR-601-201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Cervical Dystonia

Keywords

Dystonia; Cervical Dystonia

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of MTR-601 by the incidents of treatment-related adverse events as assessed by CTCAE v5.0

  To evaluate the safety and tolerability of MTR-601 in participants with cervical dystonia by the incidents of treatments emergent adverse events

  Baseline to week 6

• To evaluate the efficacy of MTR-601 in participants with cervical dystonia

  To evaluate the efficacy of MTR-601 in participants with cervical dystonia by Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) overall score change.

  Baseline to week 4

Secondary Outcomes (8)

• To evaluate the plasma concentration of MTR-601 in participants with cervical dystonia overall and by age

  Day 14 and Day 28

• To evaluate the effect of MTR-601 on Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity sub score

  Baseline to week 4

• To evaluate the effect of MTR-601 on Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity sub score

  Baseline to week 2

• To evaluate the effect of MTR-601 on Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) pain sub score

  Baseline to week 4

• To evaluate the effect of MTR-601 on Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) pain sub score

  Baseline to week 2

Study Arms (2)

MTR-601

EXPERIMENTAL

Drug: MTR-601

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MTR-601 DRUG

Capsule

MTR-601

Placebo DRUG

Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to adhere to study procedures and provide written informed consent prior to the start of any study procedures.
• Confirmed clinical diagnosis of cervical dystonia with the following:
• Treatment with botulinum toxin injections (any type) on a stable dosing regimen for ≥ 2 consecutive doses at V2 or a history of botulinum toxin injections within the last 5 years which were discontinued for reasons other than lack of efficacy.
• months (90 days) since botulinum toxin injection (≥6 months (180 days) for daxibotulinum toxinA) at V3
• TWSTRS total score ≥ 20 with the following sub scores at V2:
• Severity ≥ 15
• Disability ≥ 3
• Pain score ≥ 1)
• Willingness to not use botulinum toxin for duration of their study participation
• Adults 18-80 years of age at the time of consent.
• Weight ≥40 kg and body mass index (BMI) ≤35 kg/m2.
• Agree to practice highly effective birth control starting at screening and continuing for 30 days (females) or 90 days (males) after study treatment ends.
• For females any of the following (no donation of eggs/ova is allowed):
• Abstinence from heterosexual intercourse.
• Postmenopausal: absence of menses ≥ 12 months (without an alternative medical condition) and FSH ≥ 40 mIU/mL at screening.

Sponsors & Collaborators

• Motric Bio: lead

Study Sites (17)

Arizona Neuroscience Research, LLC

Phoenix, Arizona, 85032, United States

Location

The Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

Keck Medicine of University of Southern California

Los Angeles, California, 90033, United States

Location

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, 80113, United States

Location

Neurology One

Orlando, Florida, 32825, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Michigan State University, Department of Neurology

East Lansing, Michigan, 48824, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

University of New Mexico, The Nene and Jamie Koch Comprehensive Movement Disorder Clinic

Albuquerque, New Mexico, 87106, United States

Location

Albany Medical Center Neurosciences Institute

Albany, New York, 12208, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Vanderbilt Neurology, The Vanderbilt Clinic

Nashville, Tennessee, 37232, United States

Location

Kingfisher Cooperative, LLC

Spokane, Washington, 99201, United States

Location

West Virginia University Medicine

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Torticollis; Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 17, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): July 8, 2026
• Study Completion (Estimated): August 3, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)