Clinical Trial Results:
The HAM Ciclosporin Study: An observational trial of therapy in early or progressing HAM/TSP
Summary
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EudraCT number |
2006-002031-24 |
Trial protocol |
GB |
Global end of trial date |
29 Jan 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Oct 2019
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First version publication date |
16 Oct 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
HAM005
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00773292 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Imperial College London
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Sponsor organisation address |
South Kensingston Campus, London, United Kingdom, SW7 2AZ
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Public contact |
Prof Graham Taylor, Imperial College London, +44 020 3312 1521, g.p.taylor@imperial.ac.uk
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Scientific contact |
Prof Graham Taylor, Imperial College London, +44 020 3312 1521, g.p.taylor@imperial.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
24 Jan 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Jan 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Jan 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine in an open, pilot, proof of principle study whether ciclosporin A improves the clinical measures of patients with ‘early’ or ‘progressing’ ‘definite’ HAM/TSP
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Protection of trial subjects |
None
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2006
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Scientific research | ||
Long term follow-up duration |
6 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 7
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Worldwide total number of subjects |
7
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EEA total number of subjects |
7
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
6
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
All patients attended to National Centre for Human Retrovirology at St Mary’s Hospital, London. | ||||||||||||
Pre-assignment
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Screening details |
Eligible patients had definite HAM/TSP, as defined by ‘Belem criteria’ and either had developed first symptoms within the last two years or had progressive disease, as defined by 50% documented deterioration in 10 m timed walk over the preceding three months. | ||||||||||||
Period 1
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Period 1 title |
Pre - Treatment
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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All participants | ||||||||||||
Arm description |
4 weeks treatment | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
None
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
No treatment in the pre-treatment period
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Period 2
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Period 2 title |
Treatment
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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All participants | ||||||||||||
Arm description |
48 weeks treatment | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Ciclosporin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
2.5 - 5mg/kg/day in two equally divided doses. dose adjusted according to trough ciclosporin concentration
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Period 3
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Period 3 title |
Post treatment follow up
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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All participants | ||||||||||||
Arm description |
24 weeks treatment | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
None
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
No treatment in the pre-treatment period
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Baseline characteristics reporting groups
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Reporting group title |
Pre - Treatment
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
All participants
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Reporting group description |
4 weeks treatment | ||
Reporting group title |
All participants
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Reporting group description |
48 weeks treatment | ||
Reporting group title |
All participants
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Reporting group description |
24 weeks treatment |
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End point title |
Number of Patient With Lack of Objective Clinical Improvement [1] | ||||||
End point description |
Lack of objective clinical improvement after three months of therapy. Objective improvement was defined as any of the following comparing baseline measurements to 12, 24 and 48 weeks: i) one point decrease in the IPEC 1 scale (Instituto de Pesquisa Clínica Evandro Chagas), ii) >30% improvement in 10 m timed walk, iii) visual analogue pain score reduced by >2 points, iv) reduction of frequency or nocturia by greater than one or reduction of residual volume by more than 10% at two consecutive visits.
Proof of concept study and therefore outcomes report is descriptive only. No statistical test appropriate.
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End point type |
Primary
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End point timeframe |
12 month
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Proof of concept study and therefore outcomes report is descriptive only. No statistical test appropriate. Please see attached article. |
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No statistical analyses for this end point |
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End point title |
Changes in Clinical Outcome Measures, Time Walk at 12 Weeks Compared to Baseline | ||||||||
End point description |
Change in the time taken to walk 10 meters 0 - 12 weeks compared with baseline. A timed walk rank was created to take into account the use of walking aids.
Timed walk rank was calculated by ranking the time to walk 10 meters over all patients and visits, in the following order (highest/worst score to lowest/best score): unable to walk; able to walk, but not able to complete 10 meters (ranked on distance walked and time taken); able to walk 10 meters with a bilateral aid; able to walk 10 meters with a unilateral aid; able to walk 10 meters unaided (all ranked on time taken).
Decrease in score means improvement.
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End point type |
Secondary
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End point timeframe |
12 weeks
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
72 weeks
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
All participants
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Reporting group description |
4 weeks treatment | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/2272010 |