We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy

This study has been terminated.
(Major planned study protocol modifications)
ClinicalTrials.gov Identifier:
First Posted: July 11, 2008
Last Update Posted: July 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mitos Pharmaceuticals
The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy

Condition Intervention Phase
Alopecia Drug: MTS-01 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II, Double-Blind Placebo-Controlled, Parallel Group Study of the Safety and Preliminary Efficacy of MTS-01, for the Prevention of Alopecia Induced by Whole Brain Radiotherapy

Further study details as provided by Mitos Pharmaceuticals:

Primary Outcome Measures:
  • Investigator assessment of hair loss using a 10 point scale [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures:
  • A time to event analysis of the hair loss [ Time Frame: up to 12 weeks ]

Enrollment: 16
Study Start Date: April 2007
Estimated Study Completion Date: September 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo group
Drug: Placebo
Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment
Active Comparator: 2
Control Group
Drug: MTS-01
MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment

Detailed Description:
Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • is >/= 18 years of age
  • Has metastatic cancer to the brain for which palliative or prophylactic whole brain radiotherapy is recommended. A histological diagnosis of cancer will be required, however, a biopsy of the brain metastases will not be required
  • Can understand and sign the IRB/IEC approved informed consent, can communicate with the Investigator, and can understand with the requirements of the protocol
  • has signed the HIPAA authorization

Exclusion Criteria:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Louis Habash/ President and CEO, Mitos Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00713154     History of Changes
Other Study ID Numbers: Mito 02-02
First Submitted: July 9, 2008
First Posted: July 11, 2008
Last Update Posted: July 11, 2008
Last Verified: July 2008

Keywords provided by Mitos Pharmaceuticals:

Additional relevant MeSH terms:
Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Enzyme Inhibitors
Radiation-Protective Agents
Neuroprotective Agents