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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03474614
Other study ID # 17-0173-30-12
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date January 24, 2018
Est. completion date February 11, 2021

Study information

Verified date April 2024
Source St. Joseph's Hospital and Medical Center, Phoenix
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single center, randomized, trial that will enroll twenty (n=20) patients with a diagnosis of symptomatic cavernous malformations who are planned candidates for surgical resection by one of the investigators, and who meet all of the inclusion and exclusion criteria. Patients will be randomized into two groups: A Treatment group of ten (n=10) patients that will receive oral propranolol at a dose of 60mg per day (one 60mg ER capsule per day) for 7- to 10-days prior to surgery plus their usual medications, and a Control group of 10 (n=10) patients will receive only their routine medications. Currently, the only active treatment alternative for symptomatic cerebral cavernous malformations is surgery. A control group is required to allow for a semi-quantitative comparison with mRNA and miRNA levels in the treatment group.


Description:

This is a single center, randomized, trial that will enroll twenty (n=20) patients with a diagnosis of symptomatic cavernous malformations who are planned candidates for surgical resection by one of the investigators, and who meet all of the inclusion and exclusion criteria. Patients will be randomized into two groups: A Treatment group of ten (n=10) patients that will receive oral propranolol at a dose of 60mg per day (one 60mg ER capsule per day) for 7- to 10-days prior to surgery plus their usual medications, and a Control group of 10 (n=10) patients will receive only their routine medications. Currently, the only active treatment alternative for symptomatic cerebral cavernous malformations is surgery. A control group is required to allow for a semi-quantitative comparison with mRNA and miRNA levels in the treatment group.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date February 11, 2021
Est. primary completion date February 11, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subject is at least 18-years of age. 2. Clinical and imaging diagnosis of a symptomatic Isolated cavernous malformation or Familial cavernous malformation 3. MRI Imaging Grade Type I or Type II (see Table 1) 4. Patient is considered a candidate for surgical resection of their cavernous malformation 5. Written and informed consent obtained prior to the study enrollment. 6. Negative pregnancy test at time of enrollment for women of child-bearing potential. 7. Heart rate greater than 50 beats per minute 8. Systolic blood pressure > 90 mmHg Exclusion Criteria: 1. Subject is less than 18-years of age. 2. History of allergy to propranolol or other beta blockers. 3. Patient is already taking another beta blocker for cardiac indications. 4. History of asthma presently requiring any active treatment (oral medications or inhalers). 5. History of cardiac dysfunction (as defined by the New York Heart Association Functional Classification grade II, III or IV). 6. Heart rate < 50 beats per minute 7. Systolic blood pressure < 90 mmHg 8. History of diabetes and currently on any anti-hyperglycemic medication. 9. Pregnant and lactating women.

Study Design


Intervention

Drug:
Propranolol
The medication will be administered so that patient receives a minimum of 7- days and maximum of 10-days of treatment with propranolol prior to planned surgical resection of CCM (routine care)
Genetic:
DNA and RNA Analysis
During the operative procedure, a small sample of the patient's blood will be obtained and small (1 to 2cc) tissue sample from the resected cavernous malformation will be collected. The blood and tissue samples will be labeled and stored for subsequent DNA and RNA analysis

Locations

Country Name City State
United States Barrow Neurological Institute Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
St. Joseph's Hospital and Medical Center, Phoenix

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To measure effects of low-dose oral propranolol on global messenger RNA (mRNA) and microRNA (miRNA) expression in the blood and tissue of patients with CCM compare changes noted in mRNA and miRNA in blood and CCM tissue samples of patients who do and do not receive propranolol preoperatively for CCM -7 to -10 days until surgery
Secondary To correlate treatment response to propranolol with the underlying established mutations in cerebral cavernous malformation (CCM) genes. correlate and compare genetic mutations seen in CCM genes in tissue of patients who receive propranolol preoperatively -7 to -10 days until surgery
Secondary Record adverse event (tolerance to) related to low-dose oral propranolol (60mg ER once daily) Number of reported adverse events in patients taking propranolol -7 to -10 days until surgery
See also
  Status Clinical Trial Phase
Terminated NCT01764451 - Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins Early Phase 1
Recruiting NCT03467295 - Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHina.
Recruiting NCT01764529 - Modifiers of Disease Severity in Cerebral Cavernous Malformations