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MTR-601 for Torticollis
Fountain Valley, CA
Phase 2
Recruiting
Research Sponsored by Motric Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Disability ≥ 3
* Willingness to not use botulinum toxin for duration of their study participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 6
Summary
This trial is an 8-week study that will test the safety, side effects, and effectiveness of MTR-601 in people with cervical dystonia.
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Who is the study for?
This trial is for adults aged 18-75 with cervical dystonia, experiencing disability and pain. Participants must have been on a stable botulinum toxin treatment for over a year but agree not to use it during the study. They should weigh at least 40 kg with a BMI of ≤35 and commit to effective birth control during and after the trial.Check my eligibility
What is being tested?
The study tests MTR-601's safety, tolerability, and effectiveness against placebo in people with cervical dystonia over an 8-week period. It's randomized, meaning participants are put into the MTR-601 or placebo group by chance.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones may include reactions at the pill intake site, gastrointestinal issues like nausea or diarrhea, potential allergic reactions, headaches, dizziness or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a significant disability.
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I agree not to use botulinum toxin during the study.
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I am between 18 and 75 years old.
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I weigh at least 40 kg and my BMI is 35 or less.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the efficacy of MTR-601 in participants with cervical dystonia
To evaluate the safety and tolerability of MTR-601 by the incidents of treatment-related adverse events as assessed by CTCAE v5.0
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MTR-601Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Closest Location:Quest Research Institute· Farmington Hills, MI· 176 miles
Who is running the clinical trial?
Motric BioLead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled