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)
Sponsor:
Mitos Pharmaceuticals
Information provided by:
Mitos Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00713154
First received: July 9, 2008
Last updated: July 10, 2008
Last verified: July 2008
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Purpose
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 Blind (Subject, 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- A time to event analysis of the hair loss [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
| 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
No publications provided
| Responsible Party: | Louis Habash/ President and CEO, Mitos Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00713154 History of Changes |
| Other Study ID Numbers: | Mito 02-02 |
| Study First Received: | July 9, 2008 |
| Last Updated: | July 10, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mitos Pharmaceuticals:
|
Radiotherapy induced |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013