MTR-601 for Torticollis

Not currently recruiting at 17 trial locations

Overseen By Jenelle Lin

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Motric Bio

Must be taking: Botulinum toxin

Must not be taking: CYP3A inhibitors, CYP3A inducers, CYP3A substrates, MATE1 substrates

Disqualifiers: Endocrine, Neurological, Cardiovascular, Neoplastic, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests MTR-601, a new treatment for cervical dystonia, which causes painful neck muscle spasms. The study will assess the safety and effectiveness of MTR-601 by comparing it to a placebo (a non-active treatment). Suitable participants have experienced cervical dystonia for some time, have previously tried botulinum toxin injections, and are willing to avoid these injections during the study. This trial may interest those seeking alternative treatments for their condition. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to explore new treatment options.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop using certain medications, such as botulinum toxin and specific drugs that interact with MTR-601, for a specified period before and during the study. However, some treatments for cervical dystonia, like muscle relaxants and benzodiazepines, are allowed if the dose has been stable for at least 3 months.

Is there any evidence suggesting that MTR-601 is likely to be safe for humans?

Research has shown that MTR-601 is being tested for safety and effectiveness in treating cervical dystonia, a condition causing neck muscles to tighten uncontrollably. Although detailed safety data is not yet available, the current trial phase indicates that MTR-601 showed promise in earlier studies. This phase focuses on assessing how well participants tolerate the drug and identifying any side effects.

Treatments reaching this phase have typically been tested in small groups to check for major safety issues, suggesting that MTR-601 is likely considered safe enough for more extensive testing. However, participants should be aware that side effects can occur, and the study will closely monitor for any negative reactions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for torticollis?

Most treatments for torticollis involve muscle relaxants or botulinum toxin injections to ease muscle spasms. But MTR-601 works differently, as it targets the underlying neurological signals that cause the muscle contractions. This unique mechanism could offer more sustained relief without the need for frequent injections. Researchers are excited because this approach may lead to longer-lasting improvements and fewer side effects compared to current options.

What evidence suggests that MTR-601 might be an effective treatment for cervical dystonia?

Research shows that MTR-601, which participants in this trial may receive, may help treat cervical dystonia, a condition where neck muscles tighten uncontrollably. Previous studies used a special scale to measure the severity of the condition. Early results indicated that people taking MTR-601 had fewer symptoms than those taking a placebo. This suggests that MTR-601 might help reduce muscle spasms and discomfort linked to cervical dystonia. Although more research is needed, these early findings offer promise for those seeking relief. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I experience pain from my condition.

I am willing to follow the study rules and have signed the consent form.

My condition's severity score is 15 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

12 weeks

2 visits (in-person)

Treatment

Participants receive either MTR-601 or placebo daily for 4 weeks

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MTR-601

Trial Overview

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.

How Is the Trial Designed?

Group I: MTR-601 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Motric Bio

Lead Sponsor

Trials

2

Recruited

170+

Published Research Related to This Trial

Thyrotropin-releasing hormone significantly improved neurologic recovery in cats with experimentally induced spinal trauma compared to saline or dexamethasone, with treated animals showing normal function at six weeks (P < 0.01).

Unlike naloxone, thyrotropin-releasing hormone did not increase post-traumatic pain, suggesting it may offer a unique therapeutic approach for spinal injuries without compromising pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyrotropin-releasing hormone improves neurologic recovery after spinal trauma in cats. Faden, AI., Jacobs, TP., Holaday, JW.[2015]

In a study involving 16 patients with motor neuron disease, the TRH analogue RX77368 showed slight to moderate improvements in bulbar function, especially in speech, with effects lasting up to 90 days for some patients after repeated infusions.

The treatment also led to significant reductions in cramps and spasticity, with the best benefit-to-side effect ratio observed at a dosage of 0.2 mg/kg every 3-4 days, suggesting potential for further long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subacute administration of a TRH analogue (RX77368) in motorneuron disease: an open study. Modarres-Sadeghi, H., Rogers, H., Emami, J., et al.[2019]

RX77368, a TRH analogue, showed promising short-term improvements in symptoms like dysarthria and spasticity in patients with motor neurone disease, lasting up to 72 hours after a single intravenous dose.

In a subacute trial with repeated doses, 8 out of 12 patients experienced sustained improvements in bulbar function and spasticity for several days, although side effects were significant at higher doses, indicating a need for careful dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of TRH analogues in motorneurone disease. Guiloff, RJ.[2019]

The study found that androgen receptors (AR) are present in specific motoneuronal pools of the male rat lumbar spinal cord, with the highest levels in the spinal nucleus of the bulbocavernosus (SNB) and the lowest in the retrodorsolateral nucleus (RDLN).

Testosterone administration can restore AR labeling in gonadectomized males, indicating that AR translocates to the nucleus upon binding with testosterone, which is crucial for understanding the mechanism of androgen action in motoneurons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distribution of androgen receptor immunoreactivity in the spinal cord of wild-type, androgen-insensitive and gonadectomized male rats. Freeman, LM., Padgett, BA., Prins, GS., et al.[2016]

In a single blind crossover trial involving 7 patients with spinocerebellar degenerations, daily intramuscular injections of 2 mg thyrotropin-releasing hormone showed an acute beneficial effect on stabilogram measurements, indicating some immediate improvement in balance or stability.

However, the study did not find significant long-term therapeutic efficacy after the 2-week treatment period, although there was a noted trend suggesting potential effectiveness for chronic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and chronic effects of thyrotropin-releasing hormone (TRH) on stabilogram in spinocerebellar degenerations. Yoshida, M., Nakanishi, T., Komatsu, Y.[2019]

Citations

1.

vanderbilt.trialstoday.org

vanderbilt.trialstoday.org/trial/NCT06830642

Study of the Oral Treatment MTR-601 in Cervical Dystonia

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 ...

2.

withpower.com

withpower.com/trial/phase-2-torticollis-1-2025-87f77

MTR-601 for Torticollis · Recruiting Participants for Phase ...

Trial Overview The study tests MTR-601's safety, tolerability, and effectiveness against placebo in people with cervical dystonia over an 8-week period. It's ...

3.

rush.edu

rush.edu/clinical-trials/new-treatment-cervical-dystonia-cd

New Treatment for Cervical Dystonia (CD)

The purpose of this study is to assess how safe, tolerable, and effective MTR-601 (study drug) is in patients with cervical dystonia (CD) and to determine ...

4.

mountsinai.org

mountsinai.org/clinical-trials/study-of-oral-treatment-mtr-601-in-cervical-dystonia

Study of the Oral Treatment MTR-601 in Cervical Dystonia

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 ...

5.

trial.medpath.com

trial.medpath.com/clinical-trial/b4d0d25bd88e2a78/nct06830642-mtr-601-cervical-dystonia-treatment

Study of the Oral Treatment MTR-601 in 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.

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06830642/study-of-the-oral-treatment-mtr-601-in-cervical-dystonia

Study of the Oral Treatment MTR-601 in Cervical Dystonia

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 ...

7.

motricbio.com

motricbio.com/mtr-601

MTR-601 - Relieving Muscle Spasticity

MTR-601 is designed to offer a non-invasive approach for the treatment of cervical dystonia, targeting fast-twitch muscle fibers with the potential to decrease ...

8.

trial.medpath.com

trial.medpath.com/drug/report/0a7ab4076c42ea9b

MTR-601 | Advanced Drug Monograph - MedPath

MTR-601 is positioned to address a significant unmet need in the treatment of cervical dystonia and other spasticity-related disorders. The ...