Nadolol for Proliferating Infantile Hemangiomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01010308
First received: November 8, 2009
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of infancy.

The secondary objective is to assess the feasibility of conducting a randomized controlled trial comparing nadolol with corticosteroids and propranolol.


Condition Intervention Phase
Infantile Hemangioma
Drug: Nadolol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nadolol for Proliferating Infantile Hemangiomas: A Prospective Open Label Study With a Historical Control

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Proportion of subjects with at least 75% improvement in the extent of the hemangioma [ Time Frame: Baseline, 6months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects with at least 50% improvement in the extent of the hemangiomas [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: February 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group:

The patients in this study are infants aged 1 month to 1 year of age with head and neck hemangiomas currently causing /or with impending function loss (e.g. vision, airway obstruction, feeding, etc), or hemangiomas currently causing/or with potential for facial disfigurement

Infants aged 1 month to 1 year of age with head and neck hemangiomas that received treatment with systemic propranolol in the past 2 years as a control group

Drug: Nadolol
Nadolol will be administered orally at home starting at 0.5 mg/kg/day divided into 2 doses. Weekly, if BP and heart rate are acceptable, the dose will be increased by 0.5 mg/kg/day up to 2 mg/kg/day.
No Intervention: Historical control group
Ten infants (1-12 months of age) treated with propranolol will be identified from a Dermatology Database. Patients will be considered as controls if they were treated with propranolol before 1 year of age and had digital photography documentation of their hemangioma.
No Intervention: Angiogenesis marker control group
The angiogenesis marker control group will consist of 6 -10 patients seen in the Dermatology clinic for conditions other than IH and not receiving corticosteroids or beta blockers.

Detailed Description:

Systemic corticosteroids are currently the most frequent used medication for treatment of problematic infantile hemangiomas (IH's). Since June 2008, systemic propranolol has been an important addition to the therapeutic options for problematic IH, allowing decreased dependence on the systemic corticosteroids. So far, we have found excellent response with propranolol with minimal short-term side effects. Studies, which compared nadolol and propranolol in children with other conditions, suggest that nadolol is safer and more efficacious than propranolol. In addition, it has better dosing schedules and less central nervous system (CNS) penetration, making it suitable even for patients with suspected or proven PHACES syndrome.

  Eligibility

Ages Eligible for Study:   1 Month to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Intervention Group

  • Infants aged 1 month to 1 year of age with head and neck hemangiomas currently causing /or with impending function loss (e.g. vision, airway obstruction, feeding, etc), or hemangiomas currently causing/or with potential for facial disfigurement.

Historical Control Group

  • Infants aged 1 month to 1 year of age with head and neck hemangiomas that received treatment with systemic propranolol in the past 2 years

Angiogenesis Marker Control Group

  • Infants aged 1 month to 1 year attending dermatology clinic

Exclusion Criteria:

Intervention Group

  • Patients with PHACES syndrome (proven) or suspected PHACES (plaque like hemangioma awaiting imaging).
  • Children with history of hypersensitivity to beta blockers
  • Children with personal history or family history of a first degree relative with asthma
  • Children with known renal impairment
  • Children with known cardiac conditions which may predispose to heart blocks
  • Personal history of hypoglycemia
  • Children on medications that may interact with beta blockers

Historical Control Group:

  • No digital photography available documenting IHs progression

Angiogenesis Marker Control Group:

  • Children with IH
  • Children on beta blocker or systemic corticosteroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010308

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Elena Pope, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Elena Pope, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01010308     History of Changes
Other Study ID Numbers: 1000014079
Study First Received: November 8, 2009
Last Updated: August 1, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
infantile hemangioma
nadolol

Additional relevant MeSH terms:
Hemangioma
Hemangioma, Capillary
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Nadolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 22, 2014