UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001010
Receipt number R000001217
Scientific Title Long Term Follow-up Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Date of disclosure of the study information 2008/02/01
Last modified on 2010/08/01 18:35:24

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Basic information

Public title

Long Term Follow-up Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)

Acronym

Long Term Follow-up Phase III Clinical Trial of Leuprorelin acetate in Patients with SBMA (JASMITT)

Scientific Title

Long Term Follow-up Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)

Scientific Title:Acronym

Long Term Follow-up Phase III Clinical Trial of Leuprorelin acetate in Patients with SBMA (JASMITT)

Region

Japan


Condition

Condition

Spinal and Bulbar Muscular Atrophy (SBMA)

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To evaluate efficacy and safety of long term use of TAP-144-SR(3M) in patient with spinal and bulbar muscular atrophy (SBMA)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Pharyngeal barium residue (%)
in videofluorography

Key secondary outcomes

Clinical scores (ALSFRS-R, QMG Score, 6-minute walk)
QOL (ALSAQ-5)
serum creatine kinase (CK)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

TAP-144-SR(3M) 11.25mg subcutaneous
injection every 12 weeks

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

30 years-old <=

Age-upper limit

71 years-old >

Gender

Male

Key inclusion criteria

1) Patients who finished double-blind placebo-controlled phase III clinical trial
of TAP-144-SR (3M) in patients with spinal and bulbar muscular atrophy (SBMA).
2) Patients who have no desire to father a child.
3) Patients with written informed consent.
4) Patients who are capable of ambulatory hospital visits.

Key exclusion criteria

1) Patients who have met the termination criteria for the double-blind placebo-controlled phase III clinical trial.
2) Patients who have taken LH-RH agonists, testosterone drugs, 5-alpha-reductase inhibitors, anti-androgen drugs estrogen drugs or unapproved drugs after the recruitment of the double-blind placebo-controlled phase III clinical trial
3) Patients who have undergone operations (eg. orchiectomy), which reduce serum testosterone levels.
4) Patients who are unable to undergo videofluorography.
5) Patients who are diagnosed being depressed by M.I.N.I. Japanese version 5.0.0 major depression episode.
6) Patients who have severe complications.
7) Patients with past medical history of allergy to trial drugs in double-blind placebo-controlled phase III clinical trial.
8) Patients who are not appropriate to participate to the trial.

Target sample size

152


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Gen Sobue

Organization

Nagoya University, Graduate School of Medicine

Division name

JASMITT Clinical Trial Office

Zip code


Address

65 Tsurumai, Showa-ku, Nagoya, Aichi

TEL

052-744-2390

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

JASMITT Clinical Trial Office

Division name

Department of Neurology, Nagoya University, School of Medicine

Zip code


Address

Tsurumai 65, Showa-ku, Nagoya, Aichi

TEL

052-744-2390

Homepage URL


Email

sbma@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Neurology, Nagoya University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Center for Clinical Trials, Japan Medical Association

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Hokkaido, Tohoku Univ, Jichi Med College, Chiba Univ, Univ of Tokyo, Tokyo Medical and Dental Univ, NHO Sagamitara HP, Niigata Univ, Hamamatsu Med college, Kobe, Tottori, Nagasaki, Kumamoto Univ.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2008 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2007 Year 07 Month 31 Day

Date of IRB


Anticipated trial start date

2007 Year 07 Month 01 Day

Last follow-up date

2010 Year 03 Month 01 Day

Date of closure to data entry

2010 Year 08 Month 01 Day

Date trial data considered complete

2010 Year 09 Month 01 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 02 Month 01 Day

Last modified on

2010 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001217


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name