NCT01343355

Brief Summary

An open-label, non-randomised, uncontrolled, proof-of-concept study of patients with HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Participants will receive oral administration of tamibarotene in the amount of 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks. The patients will be followed up for further 8 weeks. Efficacy will be monitored by measuring clinical scores including motor and urination function, HTLV-1 proviral load, immunological parameters, and markers in the spinal fluid. Safety will be evaluated at the same time.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

1.2 years

First QC Date

April 25, 2011

Last Update Submit

July 21, 2011

Conditions

HTLV-I-Associated Myelopathy

Keywords

Tropical Spastic ParaparesisHAMTSP

Outcome Measures

Primary Outcomes (4)

  • Change in Soluble IL-2 Receptor level in peripheral blood

    0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks

  • Change in HTLV-I viral load in peripheral blood

    0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks

  • Change in T cell population in peripheral blood

    0,12, 24, 28 and 32 weeks

  • Change in cerebrospinal fluid examination

    baseline and after the treatment defined as from 24 to 32 weeks

Secondary Outcomes (6)

  • Change in Osame's Motor Disability Score for HAM patients

    0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks

  • Change in The Expanded Disability Status Scale (EDSS)

    0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks

  • Change in timed 10m walk

    0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks

  • Change in Manual Muscle Testing and vibratory perception of the lower limbs

    0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks

  • Change in Modified Ashworth Scale

    0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks

  • +1 more secondary outcomes

Interventions

TamibaroteneDRUG

Oral administration of tamibarotene 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks.

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have been diagnosed as HAM according to the WHO criteria
  • Patients who are positive for HTLV-I antibody in the spinal fluid
  • Patients, if female, who are not pregnant or breastfeeding, either agreed to take contraceptive measures during and two years after the treatment, or sterile
  • Patients, if male, who agreed to take contraceptive measures during and six months after the treatment
  • Patients who have been informed and understood the contents of the study and consented to participate in the signed form.

You may not qualify if:

  • Patients who has a rapid progress in the symptoms defined as an increase of two or more in Osame's Motor Disability Score for HAM patients in the past one year.
  • Patients of hyperlipidemia (serum triglyceride higher than 400 mg/dL)
  • Patients who were administered new or increased dose of corticosteroid in the past 8 weeks before the intervention
  • Patients who received steroid pulse therapy in the past 8 weeks before the intervention
  • Patients who were administered new or increased dose of immunosuppressant in the past 8 weeks before the intervention
  • Patients with a history of serious drug allergy
  • Patients with significant complication such as malignancy, severe heart failure, and other serious diseases.
  • Patients who were in the past administered etretinate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iseikai Medical Corporation, Shoyo Kashiwadai Hospital

Kanagawa, 243-0402, Japan

Location

MeSH Terms

Conditions

Paraparesis, Tropical Spastic

Interventions

tamibarotene

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsHTLV-I InfectionsDeltaretrovirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory Diseases

Study Officials

  • Yoshihisa Yamano, MD

    St. Marianna University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2011

First Posted

April 28, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

JP(1)