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Spinocerebellar DegenerationPhase 4NCT04107740

C-Trelin Orally Disintegrated(OD) Tablet 5mg in Ataxia Due to Spinocerebellar Degeneration

A Phase 4 study testing C-Trelin OD Tab(5mg Taltirelin Hydrate) in people with Spinocerebellar Degeneration, run by HLB Pharmaceutical Co., Ltd. at 8 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the efficacy and safety of C-Trelin OD Tablet 5mg(Taltirelin Hydrate) in Multicenter, randomized, double-blind, placebo-controlled clinical trial in patients with ataxia induced by spinocerebellar degeneration. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Spinocerebellar Degeneration
What is being tested?
C-Trelin OD Tab(5mg Taltirelin Hydrate)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
8 sitesSouth Korea
Study dates
4 Mar 2019to 8 Feb 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥ 20 years of age
  • Patients who voluntarily agreed to enroll in the study and signed an informed consent form
  • Patients diagnosed with ataxia (genetic or non-genetic) due to spinocerebellar degeneration by the investigator's judgment based on the results of essential diagnostic examinations stated below.
  • <Genetic ataxia>
  • Spinocerebellar ataxia(SCA)
  • Friedreich's ataxia(FA)
Show all 13Show fewer
  • Other genetic ataxia
  • <Non-genetic ataxia>
  • Idiopathic late onset cerebellar ataxia(ILOCA) The following examinations to diagnose ataxia (genetic or non-genetic) induced by spinocerebellar degeneration can be used, and the investigator has to diagnose by combining at least one diagnostic examination result among the following-items.
  • Medical history: alcohol abuse, medication history, family history
  • Genetic test: SCA 1, 2, 3, 6, 7, 8, 17, FA which is available for the patient
  • Brain MRI or CT scan: abnormalities of cerebellum and pons, brain vascular disease, or brain tumors
  • Retinal or optic nerve examination

Who cannot join

  • Patients with bed-ridden state at the time of screening even though the patient is diagnosed with ataxia induced by spinocerebellar degeneration
  • Patients with ataxia caused by stroke
  • Patients with ataxia caused by cerebrovascular, alcoholic-induced or drug-induced secondary cerebellar abnormalities
  • Patients with complications of other neurodegenerative diseases such as Parkinson's disease and multiple system atrophy(however, patients diagnosed with SCA 2, SCA 3, SCA 17 can be enrolled)
  • Patients with malignant neoplastic disease
  • Patients with kidney failure and liver failure history
Show all 19Show fewer
  • Patients with abnormalities in clinical laboratory test results as follows( Patients with liver dysfunction: Aspartate Transaminase(AST), Alanine Transaminase(ALT) > 3 times than the upper limit of normal range(ULN), Total bilirubin > 1.5 times than the ULN, Patients with renal dysfunction: Serum creatinine > 1.5mg/dl, Patients with thyroid dysfunction: free T4: above or below the normal range)
  • Patients with thyroid dysfunction at the time of screening(hyperthyroidism, hypothyroidism)
  • Patients accompanied by lesions other than spinocerebellar degeneration from Brain MRI or CT scan
  • Patients with schizophrenia, major depressive disorder
  • Patients with a history of acute myocardial infarction within 2 years of the screening visit
  • Patients with a history of unstable angina pectoris within 2 years of the screening visit
  • Patients taking contraindicated concomitant medication( However, patients with following drugs can be enrolled only if they are administered 4 weeks before the screening visit, and the type, dosage, and volume should be kept unchanged during the clinical trial.: Parkinson's disease medicine, Anxiolytics, Antidepressants, Antiepileptics, Antipsychotics, Medicine for dysuria, Sleep inducer, β blocker)
  • Patients with hypersensitivity to Taltirelin Hydrate
  • Cognitive dysfunction: Korean Version of Mini-Mental State Exam(K-MMSE) ≤ 20
  • Patients who are pregnant or lactating
  • All childbearing females who are planning to pregnant during the clinical trial or who are not using medically reliable contraceptive methods (such as intrauterine contraceptives, condoms or diaphragms combined with spermicides) except menopaused more than 1 year from the last menstruation or had undergone surgical sterilization
  • Patients participating in any other clinical trials or participated 30 days before
  • Patients whom the investigator considers inappropriate for the clinical trial due to any other reasons

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Korea8 sites

  • Chonnam National University Hospital

    Gwangju

  • Gangnam Severance Hospital

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IV Clinical Trial to Evaluate and Compare the Efficacy and Safety of C-Trelin OD Tab 5mg(Taltirelin Hydrate) in Patients With Ataxia Induced by Spinocerebellar Degeneration

The aim of this study is to evaluate the efficacy and safety of C-Trelin OD Tablet 5mg(Taltirelin Hydrate) in Multicenter, randomized, double-blind, placebo-controlled clinical trial in patients with ataxia induced by spinocerebellar degeneration.

Read the detailed description

Taltirelin Hydrate, an active substance of C-Trelin OD tablet 5mg, is an analogue of Thyrotropin Releasing Hormone(TRH). TRH is distributed widely in the brain, and exerts variety of central nervous system effects as well as endocrine activity such as releasing of Thyroid Stimulating Hormone(TSH) and Prolactin. Based on these actions, studies have been attempted for the treatment of various neurological diseases such as refractory epilepsy, cerebellar ataxia, amyotrophic lateral sclerosis, cerebellar ataxia and so on. C-Trelin OD tablet 5mg(Taltirelin Hydrate), an investigational product, is a commercially available drug that was approved by Ministry of Food and Drug Safety(MFDS) based on the safety and efficacy. However, the studies with this medicine were conducted before 1997, and the evaluation criteria for the efficacy was quite different from the current evaluation criteria.

In this clinical trial, K-SARA as an objective evaluation criteria validated in Korean patients is used to confirm the efficacy of C-Trelin to improve ataxia, and to prove safety by evaluating changes in clinical laboratory data and adverse events.

Being tested
C-Trelin OD Tab(5mg Taltirelin Hydrate), Placebo
Keywords
Spinocerebellar degeneration, Ataxia
Medical subject headings
Spinocerebellar Degenerations, Ataxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • C-Trelin OD Tab(5mg Taltirelin Hydrate)Drug

    BID, 10mg per day, for 24 weeks

  • PlaceboDrug

    BID, 10mg per day, for 24 weeks

Study groups in NCT04107740
Study groupRoleWhat they receive
C-Trelin OD Tab(5mg Taltirelin Hydrate)ExperimentalBID, 10mg per day, for 24 weeks
Receives: Drug: C-Trelin OD Tab(5mg Taltirelin Hydrate)
Placebo (0mg Taltirelin Hydrate)Placebo comparatorBID, 10mg per day, for 24 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Korean Version of Scale for the Assessment and Rating of Ataxia(K-SARA) scores

    K-SARA consists of walking, standing, sitting, speech impairment, finger following, nose-finger test, palm flipping, and heel-shin test. The total score is 40 and higher scores indicate serious ataxia.

    Measured: 24 weeks of administration compared to the baseline

Secondary outcomes (7)

  1. Changes in Korean Version of Scale for the Assessment and Rating of Ataxia(K-SARA) scores

    K-SARA consists of walking, standing, sitting, speech impairment, finger following, nose-finger test, palm flipping, and heel-shin test. The total score is 40 and higher scores indicate serious ataxia.

    Measured: 4 weeks and 12 weeks of administration compared to the baseline

  2. Changes in Clinical Global Impression - Severity(CGI-S) scores

    Changes in Clinical Global Impression(CGI) is a commonly used measure to assess the severity of symptoms, improvement, the effectiveness of treatment and it consists of Clinical Global Impression-Severity(CGI-S), Clinical Global Impression-Improvement scale(CGI-I), and Clinical Global Impression-Efficacy index(CGI-E). Clinical Global Impression-Severity(CGI-S) means overall clinical impression at the time of drug administration. It ranges from 1 to 7, higher scores indicate higher severity.

    Measured: 4 weeks, 12 weeks, and 24 weeks of administration compared to the baseline

  3. Changes in Clinical Global Impression - Improvement(CGI-I) scores

    Changes in Clinical Global Impression(CGI) is a commonly used measure to assess the severity of symptoms, improvement, the effectiveness of treatment and it consists of Clinical Global Impression-Severity(CGI-S), Clinical Global Impression-Improvement scale(CGI-I), and Clinical Global Impression-Efficacy index(CGI-E). Clinical Global Impression-Improvement scale(CGI-I) means current improvement from the patient's baseline status. It ranges from 1 to 7, and higher scores indicate worsening of symptoms.

    Measured: 12 weeks and 24 weeks of administration compared to 4 weeks of administration

  4. Changes in Clinical Global Impression - Efficacy index(CGI-E) scores

    Changes in Clinical Global Impression(CGI) is a commonly used measure to assess the severity of symptoms, improvement, the effectiveness of treatment and it consists of Clinical Global Impression-Severity(CGI-S), Clinical Global Impression-Improvement scale(CGI-I), and Clinical Global Impression-Efficacy index(CGI-E). Clinical Global Impression-Efficacy index(CGI-E) indicates the effect of the current treatment and the severity of the side effects. It is calculated by dividing the treatment effect by the side effects. The treatment effect ranges from 1 to 4, and higher scores indicate the better effect. The side effect ranges from 1 to 4, and higher scores indicate the greater side effect.

    Measured: 12 weeks and, 24 weeks of administration compared to 4 weeks of administration

  5. Changes in Korean Version of the Scale for Outcomes in Parkinson's Disease-Autonomic(K-SCOPA-AUT) scores

    Korean Version of the Scale for Outcomes in Parkinson's Disease-Autonomic(K-SCOPA-AUT) score is a patient report questionnaire for intensive evaluation of autonomic dysfunction in Parkinson's disease to determine the problems with physical functioning, such as difficulty in urinating or sweating over the past month. The total score is 69 points, and each item is evaluated on a scale of 0(never) to 3(often).

    Measured: 24 weeks of administration compared to the baseline

  6. Changes in EQ-5D-5L scores

    EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ Visual Analogue Scale (EQ VAS). EQ-5D-5L descriptive system consists of 5 items (mobility, self-care, usual activities, pain / discomfort, anxiety / depression), and 5 levels for each item [No problems (Level 1), slight problems (Level 2), moderate problems (Level 3), severe problems (Level 4), extreme problems (Level 5)]. EQ Visual Analogue Scale(EQ VAS) measures and records the subject's rating for their current health-related quality of life state on a 20cm visual analogue scale. Each endpoint is marked with "best imaginable health(100)" and "worst imaginable health(0)".

    Measured: 24 weeks of administration compared to the baseline

  7. Changes in Tinetti balance test & Gait assessment scores

    Tinetti balance test \& Gait assessment measures the gait and balance of a subject according to the subject's ability to perform a specific task. Each item is scored by 0 to 2 and higher scores indicate the better performance. The sum of each individual score consists of the total gait scores(12 points), the total balance scores(16 points), and the sum of the gait and balance scores(28 points).

    Measured: 24 weeks of administration compared to the baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2019
  2. Study start4 Mar 2019
  3. Primary completion8 Feb 2021
  4. Study completion8 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04107740
Sponsor's protocol ID
CTT-004
Status last verified
Feb 2022
First submitted
10 Sep 2019
Last updated
24 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing C-Trelin OD Tab(5mg Taltirelin Hydrate) in people with Spinocerebellar Degeneration, run by HLB Pharmaceutical Co., Ltd. at 8 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Korean Version of Scale for the Assessment and Rating of Ataxia(K-SARA) scores (time frame: 24 weeks of administration compared to the baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04107740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.

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