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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 27 July 2020
Main ID:  EUCTR2005-005915-13-GB
Date of registration: 10/04/2006
Prospective Registration: Yes
Primary sponsor: TauRx Therapeutics PTE Ltd
Public title: An Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes - Pilot Stidy of MTC in FTD and related dementia syndromes
Scientific title: An Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes - Pilot Stidy of MTC in FTD and related dementia syndromes
Date of first enrolment: 12/07/2006
Target sample size: 20
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005915-13
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1. Patients of either sex supervised by a carer competent and willing to ensure compliance with medication and who is willing to participate in completing the various assessments.

2. Female patients should not be pregnant at the start of the study or planning a pregnancy during the course of the study.

3. Patients must be able to either give written informed consent to participation in the study, with additional assent to their participation being provided by a competent carer.

4. Patients must meet either:

• Consensus Clinical Diagnostic Criteria for Frontotemporal Lobar Degeneration (Neary et al 1998) including MRI and HMPAO SPECT imaging consistent with the diagnosis
• NINDS –SPSP Clinical Criteria for Diagnosis of Probable Progressive Supranuclear Palsy including MRI and HMPAO SPECT imaging consistent with that diagnosis (Litvan et al 1996a)
• Diagnostic Criteria for Corticobasal Degeneration including MRI and HMPAO SPECT consistent with the diagnosis (Boeve et al 2003)

In addition to meeting the above criteria patients additionally must have significant cognitive impairment with a CAMCOG score of < 85.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
The patient is not eligible to participate in the study in any of the following circumstances:

1. The patient has a known sensitivity to MTC or similar agents.

2. The patient has known glucose-6-phosphate dehydrogenase deficiency.
3. The patient has known hereditary methaemoglobinaemia, has been known to have suffered an attack of acquired methaemoglobinaemia or has a blood level of methaemoglobin at screening which is above the upper limit of normal for age and laboratory.

4. The patient has significant impairment of renal, hepatic or haematological function for the age of the patient.

5. The patient has started taking prescribed medication known to have an effect on mood, cognition or motor function within the previous six weeks or has changed the dose of such medication within the same period (e.g.cholinesterase inhibitors, memantine, anticholinergics, hypnotics, sedatives, anxiolytics, neuroleptics antidepressants, antiepileptics or antiparkinsonian drugs).

6. The patient has started taking an alternative anti dementia therapy (e.g. ginkgo biloba or HRT) within six weeks or has changed their dose within that period.

7. The patient is receiving warfarin or digitalis or any other medication that has a narrow margin between effective dose and toxic dose or between effective dose and ineffective dose, where the subject would be at risk if the levels were to rise or fall due to interaction with MTC.

8. Patients who are unlikely to comply with the study procedures or with study medication.

9. Patients with significant intercurrent illness which in the opinion of the investigator may compromise either the safety of the patient or the validity of the data.

10. Females who, in the opinion of the investigator, have the potential of childbearing and are not using adequate contraception or females who are breastfeeding.

11. Patients with a history of alcohol or drug abuse defined as meeting DSM-IV criteria for substance dependence. This applies to alcohol and /or any illicit drug including cannabis within the last six months.

12. The patient has participated in a clinical investigation of a medication or device within the previous three months.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Frontotemporal Dementia and related syndromes Prevention and reversal of tau protein aggregation is a novel approach to the treatment of patients with FTD and related syndromes and has the potential for slowing the disease process as well as providing symptomatic improvement in hitherto untreatable, ultimately fatal conditions.
MedDRA version: 8.1 Level: PT Classification code 10012267
Intervention(s)

Product Name: Methylthioninium chloride
Product Code: MTC TRx0014-001 capsules
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100 -

Primary Outcome(s)
Main Objective: The primary objective of the study is to investigate and compare the effects of oral MTC at a dose of 100 mg tid on cognitive ability in patients with frontotemporal dementia with Parkinsonism linked to chromosome 17, frontotemporal dementia (lacking evidence of dominant inheritance), progressive aphasia (semantic dementia and progressive non-fluent aphasia), and corticobasal degeneration or progressive supranuclear palsy associated with dementia.

Cognitive ability will be measured by the Cambridge Cognitive Examination (CAMCOG). Interim evaluations will be made at 12 weeks (visit 2), 24 weeks (visit 4), and the final evaluation will be made at 48 weeks (Visit 6).
Primary end point(s): The primary objective of the study is to investigate and compare the effects of 100 mg tid oral MTC on cognitive ability in patients with FTD or related dementias.
Change in cognitive ability from baseline to week 48 will be measured by the Cambridge Cognitive Examination (CAMCOG).

Secondary objectives of the study are to investigate the bahavioural and pschological symtoms assessed on the NPI, clobal sate assessed on the CGI/C, functional ability assessed on the BADLS, extrapyramidal symptoms and signs assessed on the SPES, cererebral perfusion assessed by SPECT.
Secondary Objective: 1. The secondary objectives of this study are to investigate the effects of MTC on:

(i) Behavioural and psychological symptoms assessed on the Neuropsychiatric Inventory (NPI).
(ii) Global state assessed on a clinical global impression / of change (CGI/C).
(iii) Functional ability assessed on the Bristol Activities of Daily Living Scale (BADLS).
(iv) Extrapyramidal symptoms and signs assessed on the Short Parkinson’s Evaluation Scale (SPES).

2. Cerebral perfusion assessed by hexamethylpropylamine oxime single photon emission computerised tomography (HMPAO SPECT) scan.

3. Cerebral atrophy assessed by MRI.

4. The safety and tolerability of MTC will also be evaluated.
Secondary Outcome(s)
Secondary ID(s)
TRx-014-002
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 12/07/2006
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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