80 Participants Needed

MTR-601 for Torticollis

Recruiting at 9 trial locations
JL
Overseen ByJenelle Lin
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

What evidence supports the effectiveness of the drug MTR-601 for treating torticollis?

Thyrotropin-releasing hormone (TRH), which is related to MTR-601, has shown to improve neurologic recovery after spinal trauma in cats and provided slight to moderate improvements in motor neuron disease symptoms like speech and spasticity in humans. This suggests potential benefits for conditions involving muscle control, like torticollis.12345

What is the purpose of this trial?

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.

Eligibility Criteria

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.
I've been on a stable dose of botulinum toxin injections for over a year.
See 6 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MTR-601Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Motric Bio

Lead Sponsor

Trials
2
Recruited
170+

Findings from Research

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

References

Use of TRH analogues in motorneurone disease. [2019]
Distribution of androgen receptor immunoreactivity in the spinal cord of wild-type, androgen-insensitive and gonadectomized male rats. [2016]
Thyrotropin-releasing hormone improves neurologic recovery after spinal trauma in cats. [2015]
Subacute administration of a TRH analogue (RX77368) in motorneuron disease: an open study. [2019]
Acute and chronic effects of thyrotropin-releasing hormone (TRH) on stabilogram in spinocerebellar degenerations. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security