Clinical trial aimed at new therapeutic strategy for HAM by prosultiamine treatment with oral administration - Oral prosultiamine treatment against HAM patients as new therapeutics

Start Date01 Jul 2011

Sponsor / Collaborator-

JPRN-UMIN000004478 / CompletedIIT

Clinical trial aimed at a complete cure of HAM by prosultiamine treatment with oral administration - Oral prosultiamine treatment against HAM patients

Start Date01 Nov 2010

Sponsor / Collaborator-

100 Clinical Results associated with Prosultiamine

100 Translational Medicine associated with Prosultiamine

100 Patents (Medical) associated with Prosultiamine

Literatures (Medical) associated with Prosultiamine

01 Jan 2018·International journal of urology : official journal of the Japanese Urological Association

Prosultiamine for treatment of lower urinary tract dysfunction accompanied by human T‐lymphotropic virus type 1‐associated myelopathy/tropical spastic paraparesis

Article

Author: Nakamura, Tatsufumi ; Satoh, Katsuya ; Matsuo, Tomohiro ; Sakai, Hideki ; Miyata, Yasuyoshi

Objectives:

To evaluate oral prosultiamine treatment in patients with overactive bladder accompanied by human T‐lymphotropic virus type 1‐associated myelopathy/tropical spastic paraparesis.

Methods:

This was a prospective, single‐center, open‐label study. Patients received oral prosultiamine (300 mg) once daily in the morning, and the overactive bladder symptom score and urine levels of overactive bladder‐related biomarkers (nerve growth factor/creatinine and adenosine triphosphate/creatinine) 12 weeks after the initial administration were compared with the baseline values. In addition, the urodynamic parameters, including involuntary detrusor contraction and detrusor sphincter dyssynergia, were evaluated before and after treatment.

Results:

A total of 16 patients were recruited for this clinical study. In the overactive bladder symptom score, night‐time frequency, urgency and the total score improved after oral prosultiamine treatment (P = 0.028, 0.001 and 0.004, respectively). Both urinary nerve growth factor/creatinine and adenosine triphosphate/creatinine levels decreased significantly after the treatment (P = 0.004 and 0.017, respectively). Urodynamic studies showed that the maximum cystometric capacity increased significantly after the treatment. However, the symptoms disappeared because of the treatment in six of 10 patients with involuntary detrusor contraction (60%) and three of seven patients with detrusor sphincter dyssynergia (42.9%). There were no serious adverse events.

Conclusions:

The changes in urodynamic parameters and urine levels of overactive bladder‐related markers suggest that oral prosultiamine is a safe and effective treatment for overactive bladder with human T‐lymphotropic virus type 1‐associated myelopathy/tropical spastic paraparesis.

01 Jan 2016·Indian journal of ophthalmologyQ4 · MEDICINE

Outcome of transplanted donor corneas with more than 6 h of death-to-preservation time

Q4 · MEDICINE

ArticleOA

Author: Garg, Prashant ; Chaurasia, Sunita ; Mohamed, Ashik

PURPOSE:

In tropical countries, physicians are skeptic in using corneas with death-to-preservation time (DTPT) >6 h, concerns being endothelial cell viability and microbial contamination on prolonged DTPT. The objective of the study was to investigate these concerns by analyzing the outcomes of corneal transplants performed using donor corneas with DTPT >6 h.

MATERIALS AND METHODS:

The study was a retrospective case series of 65 transplants performed in 2013 with donor corneas that had DTPT >6 h (range, 6.1-9.8 h). The information on donor cornea tissues and the recipient details were collected from the eye bank and the medical records department of our tertiary eye care center. The main outcome measures were slit lamp assessment of the donor corneas, primary graft failure, graft survival, and postoperative adverse reactions, especially infections, if any.

RESULTS:

Median DTPT was 7 h. Forty-four (67.7%) corneas were evaluated as optical grade and 21 (32.3%) were deemed as therapeutic grade; 36 (55.4%) were used for optical indications. There was no relationship between DTPT and the tissue grading of corneas or endothelial cell density. Of the 23 keratoplasties for purely optical indications with a minimum follow-up of 3 months, 15 (65.2%) remained clear whereas 7 (30.4%) failed (mean follow-up 15.1 ± 6.7 months). The causes of failure were primary graft failure (n = 1) and secondary graft failure (n = 6).

CONCLUSION:

The donor corneas with DTPT 6 h to 10 h can be utilized for optical indications provided that they meet the criteria of tissue acceptance for optical use.

01 Dec 2013·BMC medicineQ1 · MEDICINE

Efficacy of prosultiamine treatment in patients with human T lymphotropic virus type I-associated myelopathy/tropical spastic paraparesis: results from an open-label clinical trial

Q1 · MEDICINE

ArticleOA

Author: Yoshihiro Nishiura ; Katsuya Satoh ; Tomoko Narita-Masuda ; Hideki Sakai ; Atsushi Kawakami ; Kentaro Yamaguchi ; Ikuo Kinoshita ; Taku Fukuda ; Shinji Yamato ; Hideki Nakamura ; Tomohiro Matsuo ; Kunihiko Nagasato ; Tatsufumi Nakamura ; Toshio Matsuzaki ; Hitoshi Sasaki

BACKGROUND:

Human T lymphotropic virus type I (HTLV-I)-associated myelopathy/tropical spastic paraparesis (HAM/TSP) is a chronic myelopathy characterized by motor dysfunction of the lower extremities and urinary disturbance. Immunomodulatory treatments are the main strategy for HAM/TSP, but several issues are associated with long-term treatment. We conducted a clinical trial with prosultiamine (which has apoptotic activity against HTLV-I-infected cells) as a novel therapy in HAM/TSP patients.

METHODS:

We enrolled 24 HAM/TSP patients in this open-label clinical trial. Prosultiamine (300 mg, orally) was administered once daily for 12 weeks. We monitored changes in the motor function of the lower extremities and urinary function as well as copy numbers of the HTLV-I provirus in peripheral blood mononuclear cells (PBMCs).

RESULTS:

Improvement in the motor function of the lower extremities based on a reduction in spasticity (for example, decrease in time required for walking and descending a flight of stairs) was observed. In an urodynamic study (UDS), bladder capacity and detrusor pressure and then maximum flow rate increased significantly. Detrusor overactivity and detrusor-sphincter dyssynergia improved in 68.8% and 45.5% of patients observed at pretreatment, respectively. Improvement in UDS corresponded with improvements in the score of nocturia-quality of life questionnaire. HTLV-I proviral copy numbers in PBMCs decreased significantly (approximately 15.4%) compared with pretreatment levels.

CONCLUSIONS:

These data suggest that prosultiamine can safely improve motor dysfunction of the lower extremities and urinary disturbance as well as reduce HTLV-I provirus levels in peripheral blood. It therefore has potential as a new therapeutic tool for HAM/TSP patients.

TRIAL REGISTRATION:

University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) number, UMIN000005969. Please see related commentary: http://www.biomedcentral.com/1741-7015/11/183.

100 Deals associated with Prosultiamine

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KEGG	Wiki	ATC	Drug Bank
D03286	Prosultiamine	A11DA	-

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